For many applications, the Australian Pesticides and Veterinary Medicines Authority (APVMA) is required to publish a summary of the application once the applicant has been notified that the application has been accepted for assessment. The summary will be removed once the application is finalised.
The types of applications requiring an application summary include those for new active constituents, products and labels and applications involving variation to products and labels, where the variation involves a change in the use, supply or disposal of the product.
The summaries include details of the applications as specified in Divisions 2.1 and 2.2 of the regulations.
Please remember to follow the guidance for preparing information lists when preparing your application to avoid sensitive information being published.
For more information, please see the questions and answers.
Use the filter and links below to find and view application summaries.
Date
Application Date
Application No
Application Number
141670
Product/Active constituent Name
Application Product Name
Restrain Plant Growth Regulator
Application Date
Application Number
141670
Application Product Name
Restrain Plant Growth Regulator
Application details
Product name:
Restrain Plant Growth Regulator
Product number:
94136
Applicant Name:
RESTRAIN COMPANY LIMITED
Application purpose and description of use:
Registration of a catalytic ethylene generator (GE) product for:
1, the pre-harvest ripening of tomatoes and bell peppers
2, the post-harvest anti sprouting treatment of potatoes, onions, garlic & shallots during extended storage
Description of data provided:
Data no
260060
Title
Document H, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260083
Title
Doc M-CP Section 1, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260106
Title
Ctgb dRR Part C (CONFIDENTIAL)
Study date
2014
Auth party contact address
RMS: The Netherlands (Ctgb)
Data no
259968
Title
Ethylene
Study date
2005
Auth party contact address
-
Data no
259991
Title
OECD Screening Information Data Sets (SIDS), Ethylene, SIDS Initial Assessment Profile
Study date
2023
Auth party contact address
-
Data no
259937
Title
Annex II, Doc L, Section 2 Reference List
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260014
Title
Ethylene
Study date
2003
Auth party contact address
-
Data no
259914
Title
Draft Assessment Report (DAR), Public version, Ethylene. Volume 3, B7
Study date
2008
Auth party contact address
RMS: United Kingdom
Data no
260037
Title
The efficacy of Restrain as sprout inhibitor in Dutch seed potato storage (cultivar and dose/temperature experiment; 2005-2006)
Study date
2006
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260054
Title
Document D1, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259960
Title
Doc N
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260008
Title
Atmospheric Oxidation of Ethylene and Ethylene oxide- Atkinson Calculation. Rivendell Consulting Ltd., Rivendell House, Stamullen, Co Meath, Ireland
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260043
Title
Effect of low concentration of Ethylene and CA on the storage three cultivars of onions
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
281786
Title
Restrain Draft Label Australia V1.2_17Dec2024
Study date
2024
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259997
Title
Environmental
Study date
2005
Auth party contact address
-
Data no
260100
Title
Ctgb dRR Part B3
Study date
2014
Auth party contact address
RMS: The Netherlands (Ctgb)
Data no
259951
Title
Annex II, Doc M, Section 4
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259977
Title
OECD Screening Information Data Sets (SIDS), Ethylene, SIDS Initial Assessment Profile
Study date
2023
Auth party contact address
-
Data no
260071
Title
Doc L-CP Section 10, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260120
Title
Application Form ???????? Sections 11 & 13
Study date
2023
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259971
Title
Ethylene ???????? IR Spectrum
Study date
2005
Auth party contact address
-
Data no
260077
Title
Doc M-CA Section 5, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260114
Title
COMMISSION IMPLEMENTING REGULATION (EU) 2023/1446 of 12 July 2023
Study date
2023
Auth party contact address
-
Data no
260126
Title
Efficacy and Crop Safety 1 Module
Study date
2023
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259934
Title
J1.2 5 Batch Analysis Appendix 2 (CONFIDENTIAL)
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260020
Title
International Programme on Chemical Safety, Environmental Health Criteria 55, Ethylene Oxide
Study date
1985
Auth party contact address
-
Data no
259928
Title
Document G
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259917
Title
Draft Assessment Report (DAR), Public version, Ethylene. Volume 3, B6 Appendices 1-2
Study date
2008
Auth party contact address
RMS: United Kingdom
Data no
260057
Title
Document F, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260063
Title
Doc L-CA Section 4, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260034
Title
The efficacy of Restrain as sprout inhibitor in Dutch ware potato storage (cultivar and dose trial; 2004-2005)
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260040
Title
Certis trial 2004-2005
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259940
Title
Annex II, Doc L, Section 5 Reference List
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260011
Title
International Programme on Chemical Safety, Environmental Health Criteria 55, Ethylene Oxide
Study date
1985
Auth party contact address
-
Data no
259988
Title
Assessment Report ???????? Ethylene Oxide
Study date
2001
Auth party contact address
-
Data no
281789
Title
Section 159(1)(b) Notice of requirement of information_Restrain_17Dec2024
Study date
2024
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259911
Title
Draft Assessment Report (DAR), Public version, Ethylene. Volume 2
Study date
2008
Auth party contact address
RMS: United Kingdom
Data no
259948
Title
Annex II, Doc M, Section 1
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260103
Title
Ctgb dRR Part B6
Study date
2014
Auth party contact address
RMS: The Netherlands (Ctgb)
Data no
259957
Title
Annex III, Doc M, Section 4
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259994
Title
Ethylene Treatments for Ripening & Degreening
Study date
2005
Auth party contact address
-
Data no
260051
Title
Document A, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260097
Title
Ctgb dRR Part A
Study date
2014
Auth party contact address
RMS: The Netherlands (Ctgb)
Data no
260000
Title
Ethylene
Study date
2003
Auth party contact address
-
Data no
259954
Title
Annex III, Doc M, Section 1
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259931
Title
Document J (CONFIDENTIAL)
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260094
Title
Ctgb authorisation Restrain 05 Dec 2008 (Potatoes ???????? Onions)
Study date
2008
Auth party contact address
RMS: The Netherlands (Ctgb)
Data no
260117
Title
Ethanol Certificate of Conformance
Study date
2022
Auth party contact address
-
Data no
260017
Title
Use of Ethylene Gas in Banana Ripening
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260031
Title
Expertise report Plant Protection Service Wageningen Division Integrated Plant Protection
Study date
2007
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260080
Title
Doc M-CA Section 8, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259974
Title
Purge and Trap thermal desorption GC analysis methodology for sampling Ethylene from living plant and waste processing biofilter. Society of automotive engineers, Inc., pp. 1 ???????? 8, 1999.
Study date
1999
Auth party contact address
-
Data no
259980
Title
IUCLID Dataset (ethylene, pure)
Study date
2000
Auth party contact address
-
Data no
259925
Title
Document E1
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260023
Title
Ethylene Effects
Study date
2023
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260074
Title
Doc M-CA Section 2, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260123
Title
Health 4 Module
Study date
2023
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259989
Title
Praxair Material Safety Data Sheet (Ethylene)
Study date
2004
Auth party contact address
-
Data no
259966
Title
CHRIS chemical sheet, ethylene (ETL)
Study date
1999
Auth party contact address
-
Data no
259943
Title
Annex III, Doc L, Section 2 Reference List
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259920
Title
Draft Assessment Report (DAR), Ethylene, Annex C, Confidential Information ??? Restrain (CONFIDENTIAL)
Study date
2008
Auth party contact address
RMS: United Kingdom
Data no
260129
Title
Restrain APVMA Covering Letter
Study date
2023
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260058
Title
Document F Appendix 1, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260035
Title
The efficacy of Restrain as sprout inhibitor in Dutch seed potato storage (cultivar and dose trial; 2004-2005)
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260112
Title
Ctgb Change of authorisation Restrain 2016
Study date
2016
Auth party contact address
RMS: The Netherlands (Ctgb)
Data no
260012
Title
EcotoxEcotoxicology database USEPA/ORD/NHEERL, Mid continent ecology division, Aquatic Records
Study date
2005
Auth party contact address
-
Data no
259912
Title
Draft Assessment Report (DAR), Public version, Ethylene. Volume 3, B1-B5
Study date
2008
Auth party contact address
RMS: United Kingdom
Data no
259995
Title
Biology
Study date
1999
Auth party contact address
-
Data no
260089
Title
Doc M-CP Section 8, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260006
Title
OECD Screening Information Data Sets (SIDS), Ethylene, SIDS Initial Assessment Profile
Study date
2023
Auth party contact address
-
Data no
260052
Title
Document B, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259949
Title
Annex II, Doc M, Section 2
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260098
Title
Ctgb dRR Part B1
Study date
2014
Auth party contact address
RMS: The Netherlands (Ctgb)
Data no
260095
Title
Ctgb authorisation Restrain 23 Dec 2014 (Tomatoes) Dutch
Study date
2014
Auth party contact address
RMS: The Netherlands (Ctgb)
Data no
259955
Title
Annex III, Doc M, Section 2
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260118
Title
Ethanol Product Specification
Study date
2022
Auth party contact address
-
Data no
259932
Title
J1 5 Batch Analysis RES-001 report (CONFIDENTIAL)
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259983
Title
Ethylene and Polyethylene. Vol. 19, page 157
Study date
1979
Auth party contact address
-
Data no
260032
Title
Expertise report Plant Protection Service Wageningen Division Integrated Plant Protection
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259969
Title
Ethylene ???????? Henry????????s Law Data
Study date
2005
Auth party contact address
-
Data no
260018
Title
Proposed regulatory decision document-Ethylene ECO sprout guard. PRDD2001-04
Study date
2001
Auth party contact address
-
Data no
260069
Title
Doc L-CP Section 4, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260075
Title
Doc M-CA Section 3, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260026
Title
Effect of ethylene treatment on the ripening, polyphenoloxidase activity and water-soluble tannin content of Taiwan Northern Banana at different maturity stages and the stability of banana polyphenoloxidase
Study date
1990
Auth party contact address
-
Data no
259926
Title
Document E2
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259975
Title
Ethlyene Oxide in Air Method no. 49
Study date
1984
Auth party contact address
-
Data no
259986
Title
CHEMINFO Chemical Profiles Created by CCOHS
Study date
2000
Auth party contact address
-
Data no
259992
Title
OECD Screening Information Data Sets (SIDS), Ethylene, SIDS Initial Assessment Profile
Study date
2023
Auth party contact address
-
Data no
260009
Title
Assessment report ???????? Ethylene oxide
Study date
2002
Auth party contact address
-
Data no
260015
Title
Ethylene Treatments for Ripening & Degreening
Study date
2005
Auth party contact address
-
Data no
260038
Title
Trial protocol for registration research on the efficacy of Restrain as sprout inhibitor in seed potato storage (2005-2006) in The Netherlands
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260109
Title
Ethylene treatment at the end of the tomato cultivation
Study date
2011
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259963
Title
The Merck Index, 12th edition, page 3837-3838
Study date
1996
Auth party contact address
-
Data no
260086
Title
Doc M-CP Section 4, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260101
Title
Ctgb dRR Part B4
Study date
2014
Auth party contact address
RMS: The Netherlands (Ctgb)
Data no
259946
Title
Annex III, Doc L, Section 5 Reference List
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260055
Title
Document D2, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260092
Title
Doc M-CP Section 11, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260003
Title
CHEMFATE search results
Study date
2005
Auth party contact address
-
Data no
260046
Title
Restrain as a sprout inhibitor in onions. Cultivar and dose trial 2004-2005
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259952
Title
Annex II, Doc M, Section 5
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260049
Title
An Evaluation of the Efficacy of Restrain???? as Sprout Inhibitor in Onion Storage in Germany 2006-2007 Season
Study date
2007
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260072
Title
Doc L-CP Section 12, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259929
Title
Document H
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259909
Title
Conclusion on the peer review of the pesticide risk assessment of the active substance ethylene
Study date
2012
Auth party contact address
-
Data no
260066
Title
Doc L-CA Section 7, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260078
Title
Doc M-CA Section 6, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259923
Title
Document C
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259972
Title
Ethylene ???????? Mass Spectrum
Study date
2005
Auth party contact address
-
Data no
260029
Title
121_IIIA, 6.1-05 Banana Ref to doc J. Please refer to Document J for this information
Study date
2023
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260115
Title
International Assessment Module
Study date
2023
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260121
Title
RESTRAIN Ethylene Generator B200. Five Batch Analysis of Catalytic Produced Ethene (CONFIDENTIAL)
Study date
2017
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259918
Title
Draft Assessment Report (DAR), Public version, Ethylene. Volume 3, B7, Appendix 3
Study date
2008
Auth party contact address
RMS: United Kingdom
Data no
259941
Title
Annex II, Doc L, Section 6 Reference List
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260010
Title
Ecotox: Ecotoxicology database USEPA/ORD/NHEERL, Mid continent ecology division, Aquatic Records
Study date
2005
Auth party contact address
-
Data no
260081
Title
Doc M-CA Section 9, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260087
Title
Doc M-CP Section 5, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260033
Title
Ethylene treatment of stored ware potatoes for processing (Sutton Bridge Potato Trial 2004)
Study date
2004
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260064
Title
Doc L-CA Section 5, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259964
Title
OECD Screening Information Data Sets (SIDS), Ethylene, SIDS Initial Assessment Profile
Study date
2023
Auth party contact address
-
Data no
259987
Title
R.E.D. Facts: Ethylene. EPA ???????? 738-F-92-012
Study date
1992
Auth party contact address
-
Data no
260110
Title
Alternative method to ripen tomatoes
Study date
2013
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259947
Title
Annex III, Doc L, Section 6 Reference List
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
281790
Title
APVMA Information List_Restrain Updated 17Dec2024
Study date
2024
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259958
Title
Annex III, Doc M, Section 5
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260041
Title
Certis potato trial 2006 Zondag
Study date
2006
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260104
Title
Ctgb dRR Part B7 Core
Study date
2014
Auth party contact address
RMS: The Netherlands (Ctgb)
Data no
260004
Title
Safety Data sheet for ethylene
Study date
2002
Auth party contact address
-
Data no
260093
Title
Doc M-CP Section 12, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260047
Title
Restrain as a sprout inhibitor in Dutch onion storage. Cultivar experiment 2005-2006.
Study date
2006
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260050
Title
An Evaluation of the Efficacy of Restrain???? as Sprout Inhibitor in Onion Storage in Germany 2007
Study date
2007
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259924
Title
Document D1
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259981
Title
Assessment report ???????? Ethylene oxide
Study date
2002
Auth party contact address
-
Data no
260030
Title
Restrain Biological Dossier 10-07
Study date
2007
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260067
Title
Doc L-CA Section 8, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260116
Title
Chemistry 3 Module (CONFIDENTIAL)
Study date
2023
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260124
Title
Residues 5 Module
Study date
2023
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260024
Title
OECD Screening Information Data Sets (SIDS), Ethylene, SIDS Initial Assessment Profile
Study date
2023
Auth party contact address
-
Data no
260073
Title
Doc M-CA Section 1, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260084
Title
Doc M-CP Section 2, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259990
Title
Post harvest Handling of Greenhouse Vegetables: Strategies for the Prevention of Ethylene Damage
Study date
1990
Auth party contact address
-
Data no
260107
Title
Tomatoes: fruit ripening at the end of the season by injecting ethylene
Study date
2013
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259967
Title
Bretherick????????s Handbook of Reactive Chemical Hazards
Study date
1999
Auth party contact address
-
Data no
260130
Title
APVMA Information List_Restrain August 2023
Study date
2023
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259944
Title
Annex III, Doc L, Section 3 Reference List
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259915
Title
Draft Assessment Report (DAR), Public version, Ethylene. Volume 3, B8
Study date
2008
Auth party contact address
RMS: United Kingdom
Data no
259961
Title
OECD Screening Information Data Sets (SIDS), Ethylene, SIDS Initial Assessment Profile
Study date
2023
Auth party contact address
-
Data no
259938
Title
Annex II, Doc L, Section 3 Reference List
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260061
Title
Document I, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260007
Title
Reregistration Eligibility Document (RED) Ethylene. List C, Case 3071
Study date
2005
Auth party contact address
-
Data no
260090
Title
Doc M-CP Section 9, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260044
Title
An investigation into the effect of Restrain System as a sprout suppressant for bulb onions
Study date
2004
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260053
Title
Document C, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259998
Title
Assessment report ???????? Ethylene oxide
Study date
2002
Auth party contact address
-
Data no
259950
Title
Annex II, Doc M, Section 3
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
281787
Title
Restrain_Generator_B200_User_Manual_EN V1.1
Study date
2019
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260001
Title
IUCLID Dataset (ethylene, pure)
Study date
2000
Auth party contact address
-
Data no
260096
Title
Ctgb authorisation Restrain 23 Dec 2014 (Tomatoes) English
Study date
2014
Auth party contact address
RMS: The Netherlands (Ctgb)
Data no
259978
Title
International Programme on Chemical Safety, Environmental Health Criteria 55, Ethylene Oxide
Study date
1985
Auth party contact address
-
Data no
259935
Title
J1.3 5 Batch Analysis Appendix 3 (CONFIDENTIAL)
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259984
Title
Guide 116, Gases Flammable (Unstable), ERG2004
Study date
2004
Auth party contact address
-
Data no
260113
Title
Data ownership and Completeness Statement
Study date
2023
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259970
Title
Ethylene ???????? UV/Visible Spectrum
Study date
2005
Auth party contact address
-
Data no
260127
Title
Restrain Draft Label Australia V1.0
Study date
2023
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259921
Title
Document A
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259927
Title
Document F
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260021
Title
Atmospheric Oxidation of Ethylene and Ethylene oxide- Atkinson Calculation. Rivendell Consulting Ltd., Rivendell House, Stamullen, Co Meath, Ireland
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260027
Title
Influence of exogenous ethylene on the ripening of banana (Musa sapientum cv. Mas)
Study date
1988
Auth party contact address
-
Data no
260070
Title
Doc L-CP Section 7, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260108
Title
Tomatoes Ripen Faster with Ethylene-Gas
Study date
2011
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259939
Title
Annex II, Doc L, Section 4 Reference List
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260016
Title
N2C2H4, C2H4<=6% Safety Data Sheet
Study date
2002
Auth party contact address
-
Data no
259916
Title
Draft Assessment Report (DAR), Public version, Ethylene. Volume 3, B9
Study date
2008
Auth party contact address
RMS: United Kingdom
Data no
260039
Title
Trial protocol for registration research on the efficacy of Restrain as sprout inhibitor in starch potato storage (2005-2006) in The Netherlands
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259985
Title
Safety Data sheet for ethylene
Study date
2002
Auth party contact address
-
Data no
260062
Title
Doc L-CA Section 2, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259962
Title
IUCLID Dataset (ethylene, pure)
Study date
2000
Auth party contact address
-
Data no
260085
Title
Doc M-CP Section 3, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260102
Title
Ctgb dRR Part B5
Study date
2014
Auth party contact address
RMS: The Netherlands (Ctgb)
Data no
260056
Title
Document E, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259993
Title
Ethylene Biosynthesis and Signaling Networks. The Plant Cell, S131-151, Supplement 2002
Study date
2002
Auth party contact address
-
Data no
260091
Title
Doc M-CP Section 10, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259945
Title
Annex III, Doc L, Section 4 Reference List
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260045
Title
Efficacy of Restrain as sprout inhibitor in onion storage in Spain [2005-2006]
Study date
2006
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
281788
Title
Restrain_Generator_B200_User_Manual_EN V1.1
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259999
Title
IUCLID Dataset (ethylene, pure)
Study date
2000
Auth party contact address
-
Data no
259930
Title
Document I
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259953
Title
Annex II, Doc M, Section 6
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260002
Title
International Programme on Chemical Safety, Environmental Health Criteria 55, Ethylene Oxide
Study date
1985
Auth party contact address
-
Data no
259979
Title
Proposed regulatory decision document-Ethylene ECO sprout guard. PRDD2001-04
Study date
2001
Auth party contact address
-
Data no
259910
Title
Draft Assessment Report (DAR), Public version, Ethylene. Volume 1
Study date
2008
Auth party contact address
RMS: United Kingdom
Data no
259936
Title
Annex II, Doc L, Section 1 Reference List
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260065
Title
Doc L-CA Section 6, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260079
Title
Doc M-CA Section 7, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260128
Title
Stimulating the ripening of capsicums using ethylene at the end of cultivation
Study date
2016
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260022
Title
Assessment report ???????? Ethylene oxide
Study date
2002
Auth party contact address
-
Data no
260028
Title
Comparative effects of acetylene and ethylene gas on initiation of banana ripening
Study date
1982
Auth party contact address
-
Data no
259922
Title
Document B
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259973
Title
CHEMINFO Chemical Profiles Created by CCOHS
Study date
2000
Auth party contact address
-
Data no
260122
Title
RESTRAIN Ethylene Generator B200. Method Validation for the Determination of the Main Product and Impurities of Catalytic Produced Ethene (CONFIDENTIAL)
Study date
2017
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259942
Title
Annex III, Doc L, Section 1 Reference List
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260013
Title
IUCLID Dataset (ethylene, pure)
Study date
2000
Auth party contact address
-
Data no
259965
Title
Atmospheric Oxidation of Ethylene and Ethylene oxide- Atkinson Calculation. Rivendell Consulting Ltd., Rivendell House, Stamullen, Co Meath, Ireland
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259919
Title
Draft Assessment Report (DAR), Public version, Ethylene. Volume 3, B7, Appendix 3
Study date
2008
Auth party contact address
RMS: United Kingdom
Data no
260105
Title
Ctgb dRR Part B7 National Addenda
Study date
2014
Auth party contact address
RMS: The Netherlands (Ctgb)
Data no
260111
Title
Accelerating the ripening of tomatoes near the end of the growing cycle using ethylene
Study date
2013
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260082
Title
Doc M-CA Section 10, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260088
Title
Doc M-CP Section 7, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260059
Title
Document G, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259913
Title
Draft Assessment Report (DAR), Public version, Ethylene. Volume 3, B6
Study date
2008
Auth party contact address
RMS: United Kingdom
Data no
260036
Title
Trial protocol for registration research on the efficacy of Restrain as sprout inhibitor in ware potato storage (2005-2006) in The Netherlands
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259959
Title
Annex III, Doc M, Section 6
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259996
Title
Ethylene
Study date
2005
Auth party contact address
-
Data no
281791
Title
SDS Catalyst
Study date
2016
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260005
Title
Atmospheric Oxidation of Ethylene and Ethylene oxide- Atkinson Calculation. Rivendell Consulting Ltd., Rivendell House, Stamullen, Co Meath, Ireland
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260042
Title
GEP Certificate
Study date
2002
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260099
Title
Ctgb dRR Part B2
Study date
2014
Auth party contact address
RMS: The Netherlands (Ctgb)
Data no
260048
Title
Efficacy of Restrain Generator as sprout inhibitor in onion storage 2006-2007
Study date
2007
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260025
Title
Banana fruit response to ethylene at different concentrations of oxygen and carbon dioxide
Study date
1993
Auth party contact address
-
Data no
260119
Title
Ethanol MSDS
Study date
2020
Auth party contact address
-
Data no
259956
Title
Annex III, Doc M, Section 3
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259933
Title
J1.1 5 Batch Analysis Appendix 1 (CONFIDENTIAL)
Study date
2005
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260019
Title
OECD Screening Information Data Sets (SIDS), Ethylene, SIDS Initial Assessment Profile
Study date
2023
Auth party contact address
-
Data no
260125
Title
Environment 3 Module
Study date
2023
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259982
Title
Assessment report ???????? Ethylene oxide
Study date
2002
Auth party contact address
-
Data no
260068
Title
Doc L-CP Section 2, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
260076
Title
Doc M-CA Section 4, Ethylene Renewal Dossier
Study date
2020
Auth party contact address
UNIT 7, THE FORUM, MINERVA BUSINESS PARK, LYNCH WOOD PETERBOROUGH United Kingdom
Data no
259976
Title
Ethylene
Study date
2003
Auth party contact address
-
Date
Application Date
Application No
Application Number
141873
Product/Active constituent Name
Application Product Name
Certainty Herbicide
Application Date
Application Number
141873
Application Product Name
Certainty Herbicide
Application details
Product name:
Certainty Herbicide
Product number:
94233
Applicant Name:
TURF CULTURE PTY LTD
Application purpose and description of use:
Registration of a 750 g/kg sulfosulfuron water dispersible granule (WG) product for the control of Sedges (Kyllinga, Mullumbimby Couch & Nutgrass) in Turf
Date
Application Date
Application No
Application Number
141514
Product/Active constituent Name
Application Product Name
verdinexor
Application Date
Application Number
141514
Application Product Name
verdinexor
Application details
Product name:
verdinexor
Product number:
94091
Applicant Name:
ANIVIVE LIFESCIENCES INC.
Application purpose and description of use:
Registration of a 50 mg verdinexor tablet product for treatment of lymphoma in dogs, in conjunction with approval of verdinexor.
Description of data provided:
Data no
260996
Title
3.2.S.1 AUS 2023 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260999
Title
3.2.S.2 AUS 2022 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260994
Title
3.2.S.4 AUS 2023 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
261002
Title
3.2.S.5 AUS 2023 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
261000
Title
3.2.S.6 AUS 2023 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260997
Title
3.2.S.7 AUS 2023 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
277002
Title
TGA non-clinical report
Study date
2021
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260995
Title
CoAs for 3 batches of active
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
261001
Title
3.2.S.3 AUS 2023 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Date
Application Date
Application No
Application Number
141515
Product/Active constituent Name
Application Product Name
Laverdia 50 mg Tablets for Dogs
Application Date
Application Number
141515
Application Product Name
Laverdia 50 mg Tablets for Dogs
Application details
Product name:
Laverdia 50 mg Tablets for Dogs
Product number:
94092
Applicant Name:
ANIVIVE LIFESCIENCES INC.
Application purpose and description of use:
Registration of a 50 mg verdinexor tablet product for treatment of lymphoma in dogs, in conjunction with approval of verdinexor.
Description of data provided:
Data no
293356
Title
Study Report 1020
Study date
2013
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293379
Title
Study Report 2685-001
Study date
2019
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
306400
Title
Active assay method
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260916
Title
US Product Information - Laverdia-CA1 (verdinexor tablets)
Study date
2022
Auth party contact address
-
Data no
260893
Title
Metabolism and toxicokinetic - TA 5
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260870
Title
CoAs - Laverdia Tablets
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260847
Title
PAA 136192 - Final Meeting advice
Study date
2022
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293350
Title
Study Report 1012
Study date
2012
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293339
Title
Breed-associated risks for developing canine lymphoma differ among countries: an European canine lymphoma network study
Study date
2018
Auth party contact address
-
Data no
260887
Title
Metabolism and toxicokinetic / short term toxicity study - TA 2
Study date
2014
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260853
Title
Excipient RDS
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260904
Title
Safety of ingredient for use in foods
Study date
2023
Auth party contact address
-
Data no
260873
Title
VICH GL6
Study date
2000
Auth party contact address
-
Data no
293376
Title
Exportin 1 (XPO1) Expression and Effectiveness of XPO1 Inhibitor Against Canine Lymphoma Cell Lines
Study date
2025
Auth party contact address
-
Data no
260910
Title
SPC
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293370
Title
Study Report 126b-401
Study date
2025
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260890
Title
Metabolism and toxicokinetic - TA 2
Study date
2012
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260913
Title
Genotoxicity 3
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
307894
Title
Usefulness of chemotherapy for the treatment of very elderly dogs with multicentric lymphoma
Study date
2018
Auth party contact address
-
Data no
260867
Title
3.2.P.3 AUS 2022 FINAL - updated v2
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293353
Title
Study Report 1004
Study date
2012
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293359
Title
Study Report 14-002
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293336
Title
Stability report 22.5 mg
Study date
2025
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293382
Title
Safety data sheets
Study date
2021
Auth party contact address
-
Data no
260884
Title
Metabolism and toxicokinetic / short term toxicity study - Lab 5
Study date
2014
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260896
Title
Metabolism and toxicokinetic - TA 6
Study date
2013
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293347
Title
Study Report 1009
Study date
2012
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260876
Title
CRM1 inhibition induces tumor cell cytotoxicity and impairs osteoclastogenesis in multiple myeloma: molecular mechanisms and therapeutic implications.
Study date
2014
Auth party contact address
-
Data no
260850
Title
EUDRA certificate for manufacturing site
Study date
2018
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260907
Title
Exploratory study
Study date
2013
Auth party contact address
-
Data no
293373
Title
Classification of Canine Malignant Lymphomas According to the World Health Organization Criteria
Study date
2011
Auth party contact address
-
Data no
260864
Title
CoAs - Excipients
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260868
Title
3.2.P.7 AUS 2022 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
306398
Title
Excipient CoA
Study date
2024
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260891
Title
Metabolism and toxicokinetic - TA 3
Study date
2012
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293377
Title
Lomustine and prednisone as a first-line treatment for dogs with multicentric lymphoma: 17 cases (2004 2005)
Study date
2007
Auth party contact address
-
Data no
293354
Title
Study Report 1030
Study date
2015
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293348
Title
Study Report 1010
Study date
2013
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260885
Title
Metabolism and toxicokinetic / short term toxicity study - Lab 6
Study date
2012
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260902
Title
Safety data sheets
Study date
2021
Auth party contact address
-
Data no
293368
Title
Study Report 1008
Study date
2012
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260879
Title
Metabolism and toxicokinetic / short term toxicity study - Lab 1
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260908
Title
Phase II study of the oral selective inhibitor of nuclear export (SINE) KPT-335 (verdinexor) in dogs with lymphoma.
Study date
2018
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293362
Title
Study Report 1001
Study date
2014
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293374
Title
The dog as a possible animal model for human non-Hodgkin lymphoma: a review
Study date
2012
Auth party contact address
-
Data no
306401
Title
Finished product specifications
Study date
2026
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260865
Title
3.2.P.2 AUS 2022 FINAL - updated
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260871
Title
3.2.P.8 AUS 2022 FINAL - updated
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
307892
Title
Explanation
Study date
2026
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260848
Title
PAA 136192 - Project Plan_FINAL_signed APVMA
Study date
2022
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293351
Title
Study Report 14-014
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260882
Title
Metabolism and toxicokinetic study - Lab 1
Study date
2012
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260888
Title
Metabolism and toxicokinetic / short term toxicity study - TA 3
Study date
2012
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293342
Title
Review: NF-kB activation in canine cancer
Study date
2022
Auth party contact address
-
Data no
293345
Title
Preclinical Evaluation of the Novel, Orally Bioavailable Selective Inhibitor of Nuclear Export (SINE) KPT-335 in Spontaneous Canine Cancer: Results of a Phase I Study
Study date
2014
Auth party contact address
-
Data no
260899
Title
Acute oral study 2
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260919
Title
EU 3a3 dossier
Study date
2021
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260905
Title
Short term toxicity study 1
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260911
Title
Genotoxicity 1
Study date
2013
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293365
Title
Clinical Implications of Targeting XPO1-mediated Nuclear Export in Multiple Myeloma
Study date
2018
Auth party contact address
-
Data no
293371
Title
Study Report 126b-401 - Appendices
Study date
2025
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260914
Title
Real World Efficacy and Toxicity of Selinexor: Importance of Patient Characteristics, Dose Intensity and Post Progression Outcomes.
Study date
2023
Auth party contact address
-
Data no
307893
Title
Summary report
Study date
2025
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260866
Title
3.2.P.4 AUS 2022 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293383
Title
FDA reaffirms safety of titanium dioxide for use in foods
Study date
2023
Auth party contact address
-
Data no
293360
Title
Study Report 1005
Study date
2012
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293337
Title
Canine lymphoma: a review
Study date
2016
Auth party contact address
-
Data no
260883
Title
Metabolism and toxicokinetic / short term toxicity study - Lab 4
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293343
Title
Therapeutic Targeting of Nuclear Export Inhibition in Lung Cancer
Study date
2017
Auth party contact address
-
Data no
293346
Title
Study Report 1019
Study date
2013
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260877
Title
Preclinical evaluation of the novel, orally bioavailable Selective Inhibitor of Nuclear Export (SINE) KPT-335 in spontaneous canine cancer: results of a phase I study
Study date
2014
Auth party contact address
-
Data no
260851
Title
Testing Laboratory ISO certificate
Study date
2022
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260900
Title
Handbook of Pharmaceutical Excipients
Study date
2017
Auth party contact address
-
Data no
260863
Title
3.2.P.1 AUS 2022 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260906
Title
Short term toxicity study 2
Study date
2012
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293366
Title
Prognostic impact and targeting of CRM1 in acute myeloid leukemia
Study date
2013
Auth party contact address
-
Data no
293372
Title
Canine Lymphomas: Association of Classification Type, Disease Stage, Tumor Subtype, Mitotic Rate, and Treatment With Survival
Study date
2013
Auth party contact address
-
Data no
293380
Title
Handbook of Pharmaceutical Excipients
Study date
2024
Auth party contact address
-
Data no
306399
Title
Active assay method validation
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260917
Title
EPAR assessment report
Study date
2021
Auth party contact address
-
Data no
260894
Title
EU dossier 3a2
Study date
2021
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293357
Title
Study Report 1002
Study date
2012
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293340
Title
Mutation of p53 Gene and Its Correlation with the Clinical Outcome in Dogs with Lymphoma
Study date
2016
Auth party contact address
-
Data no
293349
Title
Study Report 1000
Study date
2014
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260886
Title
Metabolism and toxicokinetic - TA 1
Study date
2013
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260880
Title
Metabolism and toxicokinetic / short term toxicity study - Lab 2
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260854
Title
Laverdia - Part 2 - FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260903
Title
Food Additive
Study date
2022
Auth party contact address
-
Data no
260874
Title
Laverdia - Part 3 - FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260897
Title
Method validation report
Study date
2018
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293363
Title
Phase II study of the oral selective inhibitor of nuclear export (SINE) KPT-335 (verdinexor) in dogs with lymphoma
Study date
2018
Auth party contact address
-
Data no
293369
Title
Study Report 50
Study date
2012
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260889
Title
Metabolism and toxicokinetic / short term toxicity study - TA 4
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260918
Title
EU 3a5 dossier
Study date
2021
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293335
Title
Project plan
Study date
2025
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260895
Title
Metabolism and toxicokinetic / sub-chronic study - TA
Study date
2013
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293358
Title
Study Report 1013
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260872
Title
Laverdia - Part 7 - FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293381
Title
Monographs
Study date
2023
Auth party contact address
-
Data no
293352
Title
Study Report 1003
Study date
2012
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260881
Title
Metabolism and toxicokinetic / short term toxicity study - Lab 3
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293341
Title
Expression of Apoptosis-regulating Proteins Bcl-2 and Bax in Lymph Node Aspirates from Dogs with Lymphoma
Study date
2016
Auth party contact address
-
Data no
260875
Title
Therapeutic Targeting of Nuclear Export Inhibition in Lung Cancer
Study date
2017
Auth party contact address
-
Data no
260898
Title
Acute oral study 1
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260849
Title
USFDA CFG - Laverdia 2.5, 10, 50 mg
Study date
2021
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293364
Title
Study Report K-2
Study date
2013
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260912
Title
Genotoxicity 2
Study date
2015
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260892
Title
Metabolism and toxicokinetic - TA 4
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260915
Title
The comeback of Selinexor: From toxic to tolerable.
Study date
2022
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
260869
Title
3.2.P.5 AUS 2022 FINAL
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293378
Title
Assessment of verdinexor as a canine P-glycoprotein substrate
Study date
2023
Auth party contact address
-
Data no
293384
Title
Part 8: Efficacy and Target Animal Safety
Study date
September 2025
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293355
Title
Study Report 1033
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293338
Title
Demographic risk factors for lymphoma in Australian dogs: 6201 cases
Study date
2018
Auth party contact address
-
Data no
293344
Title
CRM1 inhibition induces tumor cell cytotoxicity and impairs osteoclastogenesis in multiple myeloma: molecular mechanisms and therapeutic implications
Study date
2014
Auth party contact address
-
Data no
260901
Title
Monographs
Study date
2023
Auth party contact address
-
Data no
260878
Title
XPOVIO public summary
Study date
2022
Auth party contact address
-
Data no
260852
Title
Excipient GRAS report
Study date
1979
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293361
Title
Study Report 14-003
Study date
2016
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
293375
Title
Nuclear Export in Non-Hodgkin Lymphoma and Implications for Targeted XPO1 Inhibitors
Study date
2023
Auth party contact address
-
Data no
293367
Title
Induction of p53-mediated transcription and apoptosis by exportin-1 (XPO1) inhibition in mantle cell lymphoma
Study date
2014
Auth party contact address
-
Data no
260909
Title
Safety study 1
Study date
2019
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Data no
306402
Title
Photostability study
Study date
2023
Auth party contact address
3777 Worsham Avenue LONG BEACH United States
Date
Application Date
Application No
Application Number
141516
Product/Active constituent Name
Application Product Name
Laverdia 22.5 mg Tablets for Dogs
Application Date
Application Number
141516
Application Product Name
Laverdia 22.5 mg Tablets for Dogs
Application details
Product name:
Laverdia 22.5 mg Tablets for Dogs
Product number:
94093
Applicant Name:
ANIVIVE LIFESCIENCES INC.
Application purpose and description of use:
Registration of a 22.5 mg verdinexor tablet product for treatment of lymphoma in dogs, in conjunction with approval of verdinexor.
Date
Application Date
Application No
Application Number
141517
Product/Active constituent Name
Application Product Name
Laverdia 10 mg Tablets for Dogs
Application Date
Application Number
141517
Application Product Name
Laverdia 10 mg Tablets for Dogs
Application details
Product name:
Laverdia 10 mg Tablets for Dogs
Product number:
94094
Applicant Name:
ANIVIVE LIFESCIENCES INC.
Application purpose and description of use:
Registration of a 10 mg verdinexor tablet product for treatment of lymphoma in dogs, in conjunction with approval of
verdinexor.
Date
Application Date
Application No
Application Number
141518
Product/Active constituent Name
Application Product Name
Laverdia 2.5 mg Tablets for Dogs
Application Date
Application Number
141518
Application Product Name
Laverdia 2.5 mg Tablets for Dogs
Application details
Product name:
Laverdia 2.5 mg Tablets for Dogs
Product number:
94095
Applicant Name:
ANIVIVE LIFESCIENCES INC.
Application purpose and description of use:
Registration of a 2.5 mg verdinexor tablet product for treatment of lymphoma in dogs, in conjunction with approval of
verdinexor.
Date
Application Date
Application No
Application Number
141132
Product/Active constituent Name
Application Product Name
IMTRADE ARCHITECT RMR INSECTICIDE
Application Date
Application Number
141132
Application Product Name
IMTRADE ARCHITECT RMR INSECTICIDE
Application details
Product name:
IMTRADE ARCHITECT RMR INSECTICIDE
Product number:
93979
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 50g/L EMAMECTIN present as Emamectin Benzoate + 150g/L PIPERONYL BUTOXIDE emulsifiable concentrate product for the control of various Lepidopteran Pests Cotton, Canola, Pulses, Brassica Vegetables, Capsicum, Lettuce, Grapes, Sweetcorn and Tomatoes as specified in the Directions for Use table.
Reference details:
51321 - AFFIRM INSECTICIDE
50919 - PROCLAIM INSECTICIDE
92346 - IMTRADE ACTIVIST 225 VERIPHY SL INSECTICIDE
85276 - IMTRADE ELLIAS 300 EC INSECTICIDE
Date
Application Date
Application No
Application Number
140723
Product/Active constituent Name
Application Product Name
Diflufenican
Application Date
Application Number
140723
Application Product Name
Diflufenican
Application details
Product name:
Diflufenican
Active name:
Diflufenican
Applicant Name:
AGROBEATS TECH CO. LTD.
Application purpose and description of use:
Approval of Diflufenican for use in agricultural chemical products.
Date
Application Date
Application No
Application Number
139564
Product/Active constituent Name
Application Product Name
CANINE PARVOVIRUS Strain 630a
Application Date
Application Number
139564
Application Product Name
CANINE PARVOVIRUS Strain 630a
Application details
Product name:
CANINE PARVOVIRUS Strain 630a
Product number:
93572
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a live vaccine for active immunisation of puppies from 4 weeks of age onwards, in conjunction with the approval of live recombinant canine parvovirus strain 630a.
Description of data provided:
Data no
306237
Title
063344: Report determination of residual plasmid DNA in antigen batches. (See also 2.H.6.11)
Study date
30 April 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306323
Title
CoA batch 0001301510
Study date
8 December 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306377
Title
CEP 2000-119
Study date
22 September 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306231
Title
PDP-E/0035/18: Report study to investigate the dissemination of antigen strain in ferrets
Study date
30 September 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306340
Title
CoA batch 2198213-02
Study date
15 October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306291
Title
PDP-E/0114/15: Report dissemination study of antigen strain. (See also 3.E.6.40)
Study date
22 January 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306389
Title
TSE statement re BSE
Study date
January 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306317
Title
20R/0052: Process validation report of CPV antigen passage production at TCB
Study date
7 April 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306366
Title
CEP 2001-024
Study date
30 January 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306346
Title
CoA batch 7101832
Study date
20 April 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306297
Title
PDP-E/0019-15 Addendum to report at 5.B.17 (and at 3.E.6.32)
Study date
1 August 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306360
Title
CEP 2000-211
Study date
7 December 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306254
Title
PDP-E/0047/15: Report safety/reversion to virulence study. (See also 3.E.6.33)
Study date
12 July 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306303
Title
CoA CPC13.20.201A
Study date
22 July 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306354
Title
CEP 2000-155 (see also S0825-2_V1_1.A.Annex 5.12.2.4)
Study date
3 May 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306234
Title
PDP-E/0012/17: Report disinfection of antigen strain contaminated animal facilities
Study date
29 January 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306374
Title
CEP 2005-050
Study date
27 February 2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306334
Title
08R/0236: Report detection infectious BVD in bovine sera
Study date
26 September 2008
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306326
Title
CoA batch 500717-2
Study date
30 August 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306380
Title
CEP 2002-183
Study date
12 April 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306363
Title
CEP 2000-384
Study date
14 March 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306337
Title
Annotated schematic of plasmid
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306343
Title
Move from product to active data item was 253640
Study date
18 October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306314
Title
16R/0259: Validation Report of mycoplasma PCR for antigen
Study date
30 November 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306320
Title
Data sheet IgG FITC
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306294
Title
PDP-E/0119/15: Report thymus safety study - overdose of antigen. (See also 3.E.6.32)
Study date
14 March 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306357
Title
CEP 2000-173
Study date
3 May 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306300
Title
PDP-E/0047/15: Study protocol reversion to virulence
Study date
17 June 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306352
Title
CEP 2000-080
Study date
3 April 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306375
Title
CEP 2005-087
Study date
1 August 2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306235
Title
14R/0009: Report validation of chemical disinfection of virus families used within animal health
Study date
17 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306369
Title
CEP 2001-032
Study date
3 May 2010
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306381
Title
CEP 2003-172
Study date
24 October 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306321
Title
Data sheet B2G11-INT
Study date
31 March 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306335
Title
PDP-E-0084-15: Report genetic characterisation of master material plasmid
Study date
19 October 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306229
Title
PDP-E/0114/15: Report dissemination of antigen strain. (See also 5.B.3)
Study date
22 January 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306329
Title
CoA batch AM1359671
Study date
2 February 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306295
Title
SOP/EXP.2188E: Clinical monitoring - recording of clinical signs
Study date
25 May 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306338
Title
CoA DL795
Study date
2 September 1998
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306358
Title
CEP 2000-187
Study date
6 March 2006
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306309
Title
CoA antigen #1896
Study date
2 July 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306372
Title
CEP 2001-181
Study date
29 June 2007
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306332
Title
CoA batch 001903
Study date
24 November 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306232
Title
PDP-E/0084/15: Report genetic characterisation of antigen used in registration studies. (See also 5.B.21)
Study date
21 August 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306378
Title
CEP 2000-140
Study date
12 October 2010
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306361
Title
CEP 2000-294
Study date
23 April 2007
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306318
Title
16R/0188: Report transfer of titration of CPV antigen
Study date
19 October 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306292
Title
SAV/AAa/1: Report reversion to virulence of vaccine virus component
Study date
21 August 1996
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306341
Title
CoA batch 19K225303
Study date
27 August 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306312
Title
98R/0421: Report on efficacy of treatment of ingredient in relation to inactivation of added PCV
Study date
29 May 1998
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306298
Title
PDP-E/0084/15: DOI report - genetic characterisation of antigen used in registration studies. (See also 3.E.43)
Study date
21 August 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306349
Title
CoA batch PG15381
Study date
5 January 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306355
Title
CEP 2000-171
Study date
3 May 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306233
Title
Memo 19102017: The genetic characterisation of master seed material plasmid
Study date
19 October 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306227
Title
CPV study - Report CAP-E/0170/11 Assessment of early OOI
Study date
19 April 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306333
Title
Validation study Effectiveness of virus inactivation by gamma-irradiation
Study date
17 April 1998
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306373
Title
CEP 2001-190
Study date
7 December 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306379
Title
CEP 2000-312
Study date
27 March 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306327
Title
CoA batch CRS060917-3
Study date
9 November 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306293
Title
Move from product to active was data item 253470
Study date
6 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306364
Title
CEP 2000-387
Study date
29 May 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306387
Title
TSE statement LP0048B
Study date
23 May 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306313
Title
10R/0073: Validation Report of mycoplasma PCR
Study date
27 January 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306344
Title
MCS 19570-001 karyology and identity information on master cell stock
Study date
25 July 1999
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306301
Title
PDP-E/0114/15: Study protocol dissemination of antigen strain
Study date
5 October 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306350
Title
CoA batch B201-500 buffer lot AVH77720
Study date
11 October 2010
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306356
Title
CEP 2000-172
Study date
3 May 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306376
Title
CEP 2000-044
Study date
12 April 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306370
Title
CEP 2001-093
Study date
16 April 2007
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306324
Title
CoA batch 1320027491
Study date
10 February 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306336
Title
CoA batch 30D15 ref 515274-2 of plasmid
Study date
6 August 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306330
Title
CoA batch MB1909482
Study date
2 February 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306230
Title
PDP-E/0098/17: Report disinfection of antigen strain contaminated animal facilities
Study date
14 May 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306367
Title
CEP 2001-030
Study date
13 November 2006
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306316
Title
063344: Report on determination of residual plasmid DNA in CPV antigen batches. (See also 3.E.6.48)
Study date
30 April 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306390
Title
TSE statement no TSE risk
Study date
18 May 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306310
Title
CoA antigen #1897
Study date
2 July 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306347
Title
CoA batch 6193722
Study date
26 July 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306304
Title
CoA antigen CPC106S
Study date
11 November 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306353
Title
CEP 2000-089
Study date
25 January 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306371
Title
CEP 2001-137
Study date
13 September 2011
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306325
Title
CoA batch 22301119
Study date
22 November 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306331
Title
CoA batch RNBG0655
Study date
5 June 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306391
Title
Certificates of suitability
Study date
Feb 2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306319
Title
Data sheet A2F8-INT
Study date
29 July 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306362
Title
CEP 2000-309
Study date
27 February 2007
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306368
Title
CEP 2001-031
Study date
13 November 2006
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306342
Title
CoO batch 091M7012V and CEP
Study date
27 October 2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306299
Title
Move from product to active was data item 253487
Study date
24 November 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306311
Title
CAP-E/0071/13: Report sequence determination CPV masterseed virus
Study date
15 August 2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306348
Title
CoA batch 145948
Study date
14 February 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306305
Title
CoA antigen #1894
Study date
2 July 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306236
Title
14R/0010: Report validation of thermal inactivation for various virus families in suspension
Study date
13 January 2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306228
Title
Memo 03042020 - over-attenuation of antigen strain at higher passages in cell culture
Study date
3 April 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306322
Title
CoA Q-AB138486
Study date
30 March 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306328
Title
CoA batch K52534476
Study date
2 February 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306388
Title
TSE statement AS 5X59039
Study date
13 December 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306296
Title
SOP/EXP.2190E: In-house clinical scoring system
Study date
7 February 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306339
Title
Product specification P6463
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306365
Title
CEP 2000-392
Study date
11 August 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306345
Title
CoA batch 7H2161
Study date
12 December 1997
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306359
Title
CEP 2000-188
Study date
10 March 2006
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306302
Title
CoA 22E18
Study date
11 September 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
306351
Title
CEP 2000-076
Study date
25 November 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
139563
Product/Active constituent Name
Application Product Name
NOBIVAC PUPPY DP PLUS LIVE VACCINE
Application Date
Application Number
139563
Application Product Name
NOBIVAC PUPPY DP PLUS LIVE VACCINE
Application details
Product name:
NOBIVAC PUPPY DP PLUS LIVE VACCINE
Product number:
93571
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a live vaccine for active immunisation of puppies from 4 weeks of age onwards, in conjunction with the approval of live recombinant canine parvovirus strain 630a.
Active constituents:
Active constituent name
83898 - CANINE DISTEMPER VIRUS (CDV), STRAIN ONDERSTEPOORT
Description of data provided:
Data no
253562
Title
PSUR July 2021 to Dec 2021
Study date
1 February 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253468
Title
PDP-E/0047/15: Report safety/reversion to virulence study. (See also 3.E.6.33)
Study date
12 July 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253585
Title
Batch protocol A090C01
Study date
23 November 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253516
Title
Canine distemper (CDV) Virus SN-CDVSN
Study date
2019
Auth party contact address
-
Data no
269168
Title
MSD Response to s159 notice questions 1 to 22
Study date
8 August 2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253539
Title
Effectiveness of virus inactivation by gamma irradiation for trypsin products -1996-1997. Report.
Study date
1997
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253445
Title
Specifications rubber stopper for vial vaccine V9024
Study date
29 September 2006
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253422
Title
epar-public-assessment-report_en EMA
Study date
22 October 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253568
Title
SPC PV Variation
Study date
March 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253602
Title
QCM-10077: Validation Report sterility test of diluent hormones
Study date
20 September 2010
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253416
Title
BICON application
Study date
13 October 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253748
Title
SAV/aKa/2: Report safety and stability of avirulence of vaccine virus component
Study date
21 August 1996
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253708
Title
Batch protocol 26D17a
Study date
17 November 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253608
Title
07R/0308: Validation report TCID50 titration method of CDV in product vaccine range
Study date
11 February 2008
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253508
Title
Inactivation of viruses by aziridines
Study date
2002
Auth party contact address
-
Data no
253754
Title
Canine host range and specific Europe map along with variant sequences in protein gene of CPV and related feline, mink and raccoon parvoviruses
Study date
6 June 1988
Auth party contact address
-
Data no
253479
Title
CAP-E/0041/11: Report assay validation study
Study date
25 June 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253456
Title
Batch protocol 12I17c
Study date
30 May 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253528
Title
Humoral and cellular immune responses in swine after vaccination with inactivated pseudorabies virus
Study date
1979
Auth party contact address
-
Data no
253599
Title
18R/0064: Validation Report of titration assay for CDV in product
Study date
22 February 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288813
Title
GMP certificate sterility site
Study date
Dec 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253499
Title
PDP-E/0022/18: Study protocol efficacy of antigen strain - maternally derived antibody
Study date
20 April 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253548
Title
Dog response to inactivated canine parvovirus and feline panleukopenia virus vaccines
Study date
1981
Auth party contact address
-
Data no
253714
Title
Batch protocol 11J17a
Study date
8 March 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285516
Title
Response to APVMA
Study date
Feb 2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253522
Title
Accuracy of next generation sequencing platforms
Study date
2014
Auth party contact address
-
Data no
253691
Title
WI-4055-0359: Various diluents, identity
Study date
27 November 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253765
Title
Role of capsid proteins in parvoviruses infection
Study date
2015
Auth party contact address
-
Data no
253734
Title
Evolution of CPV involved loss and gain of feline host range
Study date
1 November 1995
Auth party contact address
-
Data no
253579
Title
CoA Solvent H472202
Study date
6 December 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253591
Title
01R/0290: Validation Report PCV-2 inactivation
Study date
11 May 2001
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253628
Title
Master seed virus protocol batch 501-032201
Study date
20 February 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253685
Title
WI-4055-0034: Various dilients - identity
Study date
27 November 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253536
Title
Measles virus
Study date
2013
Auth party contact address
-
Data no
253436
Title
Summary of Product Characteristics, Labelling, Mockups
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253728
Title
PDP-E: Post approval change management protocol for batch size increase
Study date
1 September 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253419
Title
PAA2 written assistance
Study date
12 January 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253751
Title
SAV/AJ/19: Report safety of antigen component in vaccine in cats
Study date
23 August 1996
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253442
Title
CoA glass vial vaccine 6104604654
Study date
7 March 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
269165
Title
PDP-E/0076/17 study to investigate serological response
Study date
20 August 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253588
Title
CoA KC Solvent A284A01
Study date
22 November 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253565
Title
PSUR ANNEX end Dec 2021 to June 2022
Study date
1 June 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253542
Title
Cell culture-derived influenza vaccines from vero cells: a new horizon for vaccine production
Study date
2012
Auth party contact address
-
Data no
253519
Title
Epidemiology and emergence of Schmallenberg virus. Part 1: origin, transmission and differential diagnosis
Study date
2016
Auth party contact address
-
Data no
253413
Title
Product Manufacturer Flowchart
Study date
September 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253745
Title
A novel antigenic variant of CPV from a Vietnamese dog
Study date
29 April 2004
Auth party contact address
-
Data no
253757
Title
Sequence of antigen strain
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253711
Title
Batch protocol 18D18a
Study date
13 August 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253559
Title
Tick-bourne encephalitis
Study date
2015
Auth party contact address
-
Data no
253505
Title
S15303-00: Study protocol clinical study to assess efficacy and safety of new vaccine
Study date
25 May 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253705
Title
CoA Diluent batch K4510
Study date
11 March 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253525
Title
Vaccination of dogs with modified distemper virus
Study date
1939
Auth party contact address
-
Data no
288816
Title
CoA D004 D005 D006
Study date
2004
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253453
Title
Statement sterility result 01K17 and 03K17
Study date
29 August 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253502
Title
PDP-E/0084/17: Study protocol efficacy of antigen strain - maternally derived antibody
Study date
2 October 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253551
Title
High rate of viral evolution associated with the emergence of carnivore parvovirus
Study date
2005
Auth party contact address
-
Data no
253476
Title
PDP-E/0034/18: Report efficacy study of improved vaccine - onset of immunity
Study date
12 February 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253737
Title
Natural variation of CPV
Study date
29 November 1985
Auth party contact address
-
Data no
253694
Title
WI-4066-0599: Titration of live antigen strain in tissue culture
Study date
21 April 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253768
Title
19R/0140: Report safety and spread study of antigen strain in the non-target species mice after oral administration
Study date
26 September 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253545
Title
Serum antibody response to canine parvovirus, canine adenovirus-1, and canine distemper virus in dogs with known status of immunization: Study of dogs in Sweden
Study date
1988
Auth party contact address
-
Data no
253717
Title
Batch protocol 10E19a
Study date
11 August 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253425
Title
1-responses-to-questions_Day 180
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253439
Title
Detailed and critical summary on Efficacy Tests
Study date
22 October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253688
Title
TI-4066-0151: Determination of quality of infectious antigen in samples
Study date
2 July 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253625
Title
Acceptance criteria for levels of antibodies (includes references)
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253482
Title
PDP-E/0084/17: Report efficacy of antigen strain with maternally derived antibody
Study date
12 November 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253488
Title
06R/0249: Report safety study (LEP) - double dose of a vaccine plus double dose of another vaccine
Study date
18 October 2006
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253725
Title
LIVE-IMPR-19110: Stability report assessment of antigen titres and residual moisture in product
Study date
23 August 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253731
Title
Annex I, II, III Proposed SPC_Labelling_Mockups (EU) (See also S/0825_V3_1.B)
Study date
December 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253433
Title
Declaration of DDPS (Detailed Description of the Pharmacovigilance System)
Study date
11 November 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253582
Title
Batch protocol L4 FFD16.46.001-002B
Study date
14 September 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253420
Title
International Assessment - Summary of Submitted Data
Study date
December 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253491
Title
SAV/ADa1/11: Report challenge experiment with virulent antigen
Study date
21 August 1996
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253752
Title
SAV/AJa/18: Report safety of antigen component in vaccine in ferrets
Study date
23 August 1996
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253537
Title
Preparation of a ???????Quil-A????????-adjuvanted, inactivated porcine parvovirus vaccine. A summary
Study date
1981
Auth party contact address
-
Data no
253514
Title
Preliminary development of a live attenuated canine parvovirus vaccine from an isolate of British origin
Study date
1987
Auth party contact address
-
Data no
269166
Title
Breed-related risk factors for canine parvovirus enteritis
Study date
15 September 1985
Auth party contact address
-
Data no
253566
Title
PSUR July 2022 to Dec 2022
Study date
3 February 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253543
Title
Duration of serologic response to five viral antigens in dogs
Study date
2004
Auth party contact address
-
Data no
253520
Title
Leptospira as an emerging pathogen: a review of its biology, pathogenesis and host immune responses
Study date
2010
Auth party contact address
-
Data no
253414
Title
OGTR Pre-Application Assistance Request
Study date
October 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253497
Title
PDP-E/0034/18: Study protocol efficacy of improved vaccine - antigen onset of immunity
Study date
25 September 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253746
Title
CPV-2 vaccine protects against virulent challenge with type 2c virus
Study date
26 September 2007
Auth party contact address
-
Data no
253451
Title
Batch protocol Batch 01K17
Study date
29 August 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253700
Title
Batch protocol BVL001A
Study date
7 June 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253712
Title
Batch protocol 18D18b
Study date
13 August 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253760
Title
Sequence of plasmid
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253554
Title
Characterization of vero cells
Study date
1988
Auth party contact address
-
Data no
253560
Title
Registration Overview
Study date
February 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253706
Title
CoA Diluent batch K4707
Study date
11 March 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253606
Title
Batch protocol 26D17a
Study date
17 November 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253503
Title
S15303-00: Clinical study to assess efficacy and safety of new vaccine
Study date
9 July 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253740
Title
Phylogenetic analysis of CPV VP2 gene in Taiwan
Study date
10 March 2005
Auth party contact address
-
Data no
253597
Title
17R/0278: Validation Report sterility test for product
Study date
6 November 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253763
Title
PDP-E/0074/15: Report reversion to virulence. (See also 5.B.2)
Study date
12 July 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253454
Title
Batch protocol 12I17a
Study date
30 May 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253477
Title
PDP-E/0099/17: Report efficacy study of improved vaccine - duration of immunity
Study date
22 May 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253689
Title
WI-4066-0199: Determination of vaccine residual moisture
Study date
15 February 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253720
Title
Batch protocol A183A
Study date
15 March 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253546
Title
Pharmaceutical photostability and stabilization technology
Study date
2010
Auth party contact address
-
Data no
253769
Title
19R/0139: Report safety and spread study of antigen strain after oral administration to non-target species
Study date
28 August 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253428
Title
Overall Summary of EU Dossier
Study date
December 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253440
Title
Specifications glass vial vaccine 10000096051
Study date
18 November 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253577
Title
CoA Solvent D3733
Study date
1 August 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253583
Title
Batch protocol L4 XS 162291
Study date
25 July 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253683
Title
WI-4066-0014: Method of determination of appearance
Study date
14 May 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253726
Title
17R/0164: Report analysis of effect of solvent on pH on Ph of reconstituted vaccines
Study date
27 July 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253732
Title
Curriculum vitae
Study date
11 June 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253534
Title
Epidemiology and host spectrum of Borna disease virus infections
Study date
2013
Auth party contact address
-
Data no
253434
Title
Detailed description of Pharmacovigilance System DDPS
Study date
1 July 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253586
Title
Batch protocol KC A092B01
Study date
23 November 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253540
Title
Comparison of Automated Differential Blood Cell Counts From Abbott Sapphire, Siemens Advia 120, Beckman Coulter DxH 800, and Sysmex XE-2100 in Normal and Pathologic Samples
Study date
2013
Auth party contact address
-
Data no
253563
Title
PSUR Annex July 2021 to Dec 2021
Study date
1 February 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253417
Title
BICON application accepted
Study date
13 October 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253494
Title
PDP-E/0119/15: Report raw data folder 2 - histology report
Study date
6 July 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253517
Title
An inactivated baby hampster kidney cell rabies vaccine for use in dogs and cattle
Study date
1971
Auth party contact address
-
Data no
253448
Title
CoA rubber stopper for vial solvent V0924
Study date
23 May 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253471
Title
Summary of product characteristics for other vaccine product (1)
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253697
Title
WI-5089-0006: Sterility test on biological products by means of membrane filtration
Study date
23 April 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253709
Title
Batch protocol 26D17b
Study date
17 November 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253411
Title
GMP 2
Study date
23 July 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253749
Title
Canine viral enteritis. Chapter 8.
Study date
October 2019
Auth party contact address
-
Data no
253511
Title
A modified live canine parvovirus vaccine. II. Immune response
Study date
1982
Auth party contact address
-
Data no
253457
Title
Batch protocol 25D17
Study date
12 October 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253703
Title
Batch protocol BVL004A
Study date
7 June 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253557
Title
Clinical use of serum parovirus and distemper virus antibody titers for determining revaccination strategies in healthy dogs
Study date
2000
Auth party contact address
-
Data no
253408
Title
AU data and overall executive summary of submitted data
Study date
December 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253431
Title
Scientific Advice given by CVMP or member state
Study date
16 February 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253480
Title
PDP-E/0015/18: Report efficacy study of improved vaccine - onset of immunity. (See also 3.E.6.34)
Study date
21 September 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253600
Title
18R/0065: Validation Report of titration assay for CPV in final product control
Study date
22 February 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288814
Title
SOP TI-5089-0002
Study date
Oct 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253500
Title
PDP-E/0015/18: Study protocol efficacy of improved vaccine - antigen onset of immunity
Study date
5 April 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253743
Title
A CPV mutant is spreading in Italy
Study date
11 November 2003
Auth party contact address
-
Data no
253523
Title
The emergence of porcine circovirus 2b genotype (PCV-2b) in swine in Canada
Study date
2007
Auth party contact address
-
Data no
253766
Title
CAP-E-0040-13: Report safety of the administration of antigen virus in cats
Study date
7 May 2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253580
Title
CoA Solvent H502801
Study date
14 June 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253437
Title
Detailed and critical summary on Quality
Study date
16 October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253474
Title
PDP-E/0037/17: Report canine distemper challenge validation model
Study date
6 September 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253686
Title
WI-4066-0050: Extraneous agents test for vaccines on secondary DK cells
Study date
22 January 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253723
Title
Batch protocol 27A21B
Study date
4 June 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253531
Title
Infection studies on human cell lines with porcine circovirus type 1 and porcine circovirus type 2
Study date
2004
Auth party contact address
-
Data no
253629
Title
CoA working seed virus batch 29L06
Study date
21 January 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253729
Title
Environmental Risk Assessment - Safety Tests
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253443
Title
Specifications aluminium cap vial vaccine AHC13.0005
Study date
17 January 1997
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253489
Title
Memo 27032020: Levels of antigen maternally derived antibody in the field
Study date
27 March 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253518
Title
Guidelines for the vaccination of dogs and cats
Study date
2016
Auth party contact address
-
Data no
253589
Title
CoA KC Solvent A291A01
Study date
27 November 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253472
Title
Summary of product characteristics for other vaccine product (2)
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253758
Title
Sequence of the hybrid strain
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253698
Title
WI-5123-0001: Testing for presence/absence of Mycoplasma
Study date
17 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253506
Title
Molecular epidemiology of canine parvovirus in Morocco
Study date
2016
Auth party contact address
-
Data no
253512
Title
Wesselsbron Disease: Wesselsbron Fever
Study date
2017
Auth party contact address
-
Data no
253412
Title
GMP 3
Study date
10 January 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253558
Title
United States of America????????s status of OIE reportable diseases: 2017
Study date
2017
Auth party contact address
-
Data no
253704
Title
CoA Diluent batch K4407
Study date
11 March 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253432
Title
QP Declaration concerning GMP compliance of active substance manufacture
Study date
17 October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253552
Title
Canine parvovirus type 2 vaccine protects against virulent challenge with type 2c virus
Study date
2008
Auth party contact address
-
Data no
253526
Title
Zoologic and histologic modification of the distemper virus by ferret passage
Study date
January 1945
Auth party contact address
-
Data no
253624
Title
USP monograph reagents
Study date
1 May 2018
Auth party contact address
-
Data no
253761
Title
PDP-E/0095/17: Report safety study of improved vaccine - administration of an overdose followed by a repeat dose. (See also 5.B.1)
Study date
22 October 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253767
Title
PDP-E/0075/17: Report safety study of antigen virus strain in ferrets. (See also 5.B.7)
Study date
6 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253695
Title
TI-5089-0001: Sterility test on biological products and media products
Study date
22 May 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253738
Title
Rapid antigenic-type replacement and DNA sequence evolution of CPV
Study date
19 August 1991
Auth party contact address
-
Data no
253744
Title
First detection of CPV-2c in pups with haemorrhagic enteritis in Spain
Study date
8 May 2006
Auth party contact address
-
Data no
253718
Title
Batch protocol 10E19b
Study date
11 August 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253569
Title
OGTR Application Form
Study date
March 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253426
Title
Annex I-II-III_SPC_Labelling
Study date
October 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253475
Title
19R/0065: Report validation antigen neutralisation assay
Study date
21 May 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253638
Title
Master seed test results on master cell stock batch 111287 - information on master cell stock
Study date
7 April 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253724
Title
19R/0033: Photostability Report - light stress test on product
Study date
16 January 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253532
Title
Use of serologic tests to predict resistance to Canine distemper virus-induced disease in vaccinated dogs
Study date
2015
Auth party contact address
-
Data no
253581
Title
Test Report CDV MS 030692
Study date
17 September 1992
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253515
Title
Canine distemper virus antibody neutralization
Study date
2019
Auth party contact address
-
Data no
269167
Title
Risk factors associated with parvovirus enteritis in dogs: 283 cases (1982-1991)
Study date
15 February 1996
Auth party contact address
-
Data no
253492
Title
PDP-E/0095/17: Study protocol safety of an improved vaccine - 10x dose followed by a repeat dose
Study date
29 November 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253609
Title
061381: Report additional validation tests immunofluorescence assay for batch release testing of vaccine
Study date
15 April 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253561
Title
PSUR Dec 2020 to June 2021
Study date
6 August 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253538
Title
Tumorigenicity of vero cells
Study date
1984
Auth party contact address
-
Data no
253423
Title
CVMP Opinion EMA_CVMP
Study date
7 October 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253446
Title
CoA rubber stopper for vial vaccine 110013806
Study date
26 April 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253509
Title
Application of agar-gel diffusion analysis to a study of the antigenic structure of inactivated vaccines prepared from the virus of foot and mouth disease.
Study date
1959
Auth party contact address
-
Data no
253498
Title
PDP-E/0099/17: Study protocol efficacy of improved vaccine - antigen duration of immunity
Study date
12 December 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253415
Title
Advice Pre-application Assistance
Study date
4 November 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253452
Title
Batch protocol Batch 03K17
Study date
29 August 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253747
Title
SAV/AK/7: Report safety and stability of avirulence of vaccine virus component
Study date
22 August 1996
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253601
Title
CAP-E/0063/11: Validation report of titration assy for CPV antigen by immunofluorescence antibody
Study date
10 October 2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253755
Title
Cloning scheme of antigen
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253701
Title
Batch protocol BVL002A
Study date
7 June 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253707
Title
Batch protocol 25D17
Study date
12 October 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253555
Title
Development and evaluation of an efficient cell-culture system for Hepatitis E virus
Study date
2007
Auth party contact address
-
Data no
253409
Title
Overall Table of Contents to EU Dossier
Study date
December 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253598
Title
17R/0314: Validation Report of test for mycoplasma (culture method) for product
Study date
27 November 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253764
Title
PDP-E/0015/18: Report efficacy study of an improved vaccine - onset of immunity. (See also 5.B.14)
Study date
21 September 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253455
Title
Batch protocol 12I17b
Study date
30 May 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253478
Title
PDP-E/0022/18: Report efficacy study with maternally derived antibody
Study date
20 August 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253549
Title
Maternally derived immunity to canine parvovirus infection: transfer, decline, and interference with vaccination
Study date
1982
Auth party contact address
-
Data no
288812
Title
s159 response
Study date
Jun 2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253572
Title
Batch protocol CPC15.20.106Z Field trial V+6
Study date
20 November 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253715
Title
Batch protocol 11J17b
Study date
8 March 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253692
Title
WI-4066-0509: Identification of antigens
Study date
9 October 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253741
Title
Evolution of CPV-2 and implicance for antigenic/genetic characterisation
Study date
18 September 2005
Auth party contact address
-
Data no
253721
Title
Batch protocol 27A21
Study date
4 June 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253735
Title
Analysis of VP2 gene sequences of CPV isolates in India.
Study date
3 April 2006
Auth party contact address
-
Data no
253429
Title
Micro-organisms handled in the production facilities
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253435
Title
Active substance declaration
Study date
November 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253684
Title
WI-4066-0032: Various diluents - identity
Study date
22 August 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253529
Title
Preliminary note on the cultivation of Green????????s distemperoid virus in fertile hen eggs
Study date
1948
Auth party contact address
-
Data no
253535
Title
Occupancy and mechanism in antibody-mediated neutralization of animal viruses
Study date
2002
Auth party contact address
-
Data no
253578
Title
CoA Solvent H181601
Study date
23 November 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253727
Title
18R/0217: Report effect of solvent pH on pH of reconstituted product
Study date
10 July 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
301435
Title
Assessing Canine Parvovirus Vaccine Performance in Puppies with Maternally Derived Antibody: An Improved Study Design
Study date
2025
Auth party contact address
-
Data no
253564
Title
PSUR Jan 2022 to June 2022
Study date
8 August 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253587
Title
CoA KC Solvent A269A01
Study date
22 December 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253441
Title
CoA glass vial vaccine prewashed 5200607694 - Pos. 06
Study date
29 February 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253447
Title
Specifications rubber stopper for vial solvent V9250
Study date
21 December 2006
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253418
Title
PAA2 Request
Study date
23 August 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253424
Title
1-responses-to-questions_Day 121
Study date
2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253541
Title
Duration of serological response to canine parvovirus-type 2, canine distemper virus, canine adenovirus type 1 and canine parainfluenza virus in client-owned dogs in Australia
Study date
2012
Auth party contact address
-
Data no
253510
Title
The use of acetylethyleimine in the production of inactivated foot and mouth diseases vaccines
Study date
1963
Auth party contact address
-
Data no
253710
Title
Batch protocol 18D18
Study date
13 August 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253702
Title
Batch protocol BVL003A
Study date
7 June 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253750
Title
SAV/BF/20: Report overdose safety test on a vaccine product
Study date
21 August 1996
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253756
Title
Sequence of antigen strain
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253410
Title
GMP 1
Study date
20 September 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253556
Title
Measurement of antibodies after parvovirus vaccination
Study date
1985
Auth party contact address
-
Data no
253693
Title
WI-4066-0526: Determination of colour of solutions and supernatants of suspensions
Study date
11 December 2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
288815
Title
SOP TI-4066-0277
Study date
Aug 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253501
Title
PDP-E/0033/18: Study protocol efficacy of improved vaccine - antigen duration of immunity
Study date
3 September 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253550
Title
Distemper vaccination of dogs: factors which could cause vaccine failure
Study date
1986
Auth party contact address
-
Data no
253524
Title
Encephalitis in dogs produced by distemper virus
Study date
1956
Auth party contact address
-
Data no
253742
Title
Evidence for evolution of CPV-2 in Italy
Study date
2001
Auth party contact address
-
Data no
253593
Title
00R/0430: Validation report steam sterilisation process
Study date
7 August 2000
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253716
Title
Batch protocol 10E19
Study date
11 August 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253438
Title
Detailed and critical summary on Safety Tests
Study date
11 October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253687
Title
WI-4066-0085: Contents on average
Study date
12 April 2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253736
Title
Selective regimen shift and demographic growth increase associated with emergence of high-fitness variants of CPV
Study date
29 March 2006
Auth party contact address
-
Data no
253722
Title
Batch protocol 27A21A
Study date
4 June 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253530
Title
Canine distemper-immunisation with avianised virus
Study date
1956
Auth party contact address
-
Data no
253430
Title
Declaration of TSE Compliance
Study date
11 November 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253481
Title
PDP-E/0033/18: Report efficacy study of improved vaccine - duration of immunity
Study date
19 February 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253730
Title
Assessment of risk required for vet products re GMOs
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
301436
Title
Challenge Study PDP-E 19.48.039
Study date
2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253444
Title
CoA aluminium cap vial vaccine AHC13 0005 027000
Study date
19 January 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253467
Title
PDP-E/0095/17: Report safety study of an improved vaccine. (See also 3.E.6.31)
Study date
22 October 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253490
Title
Health Monitoring Report
Study date
19 December 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253513
Title
A comparison of canine distemper vaccine and measles vaccine for the prevention of canine distemper in young puppies
Study date
1994
Auth party contact address
-
Data no
253567
Title
PSUR ANNEX July 2022 to Dec 2022
Study date
1 December 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253421
Title
CVMP Assessment Report EMA_CVMP
Study date
7 October 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253544
Title
A systematic review of Rift Valley Fever epidemiology 1931-2014
Study date
2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253699
Title
WI-5123-0006: Testing for presence/absence of mycoplasma contamination
Study date
27 May 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253759
Title
Sequence of antigen strain
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253607
Title
Batch protocol 26D17b
Study date
17 November 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253553
Title
Use of the ATG-treated newborn rat for in vivo tumorgenicity testing of cell substrates
Study date
1982
Auth party contact address
-
Data no
253507
Title
Inactivation of viral antigens for vaccine preparation with particular reference to the application of binary ethylenimine
Study date
1990
Auth party contact address
-
Data no
253753
Title
Schematic overview of cloning plasmid and sequence of synthesised antigen fragment
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
284393
Title
Certificates of Analysis - Raw Materials
Study date
Feb 2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253527
Title
Infectious diseases of the dog and cat
Study date
October 2019
Auth party contact address
-
Data no
253504
Title
S15303-00: Veterinary monitoring statement field trial
Study date
October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253690
Title
WI-4066-0203: Identification of antigen by reaction with specific monoclonal antibodies
Study date
3 June 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253696
Title
WI-5089-0003: Sterility testing of pharmaceutical products through membrane filtration
Study date
7 February 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253547
Title
Import Risk Analysis: cattle from Australia, Canada, the European Union, and the United states of America ???????? Final
Study date
2009
Auth party contact address
-
Data no
253596
Title
17R/0277: Validation Report sterility test for product
Study date
6 November 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253713
Title
Batch protocol 11J17
Study date
8 March 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253719
Title
Batch protocol A182A
Study date
15 March 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253762
Title
PDP-E/0119/15: Report thymus safety study of an overdose of antigen. (See also 5.B.17)
Study date
14 March 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253739
Title
Evolution of the feline-subgroup parvoviruses and the control of canine host range in vivo
Study date
4 May 1995
Auth party contact address
-
Data no
253521
Title
Determinants of spontaneous mutation in the bacterium Escherichia coli as revealed by whole-genome sequencing
Study date
2015
Auth party contact address
-
Data no
253533
Title
Tumorigenicity of continuous monkey cell lines in in vivo and in vitro systems
Study date
1982
Auth party contact address
-
Data no
253639
Title
111287 karyology and identity - information on master cell stock
Study date
13 August 1995
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253733
Title
Preliminary development of a live attenuated CPV vaccine from British isolate
Study date
4 April 1967
Auth party contact address
-
Data no
253427
Title
Commission Implementing Decision
Study date
9 December 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
253584
Title
Batch protocol A085B01
Study date
22 December 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
139403
Product/Active constituent Name
Application Product Name
SA WATER COPPER SULPHATE ALGICIDE
Application Date
Application Number
139403
Application Product Name
SA WATER COPPER SULPHATE ALGICIDE
Application details
Product name:
SA WATER COPPER SULPHATE ALGICIDE
Product number:
51854
Applicant Name:
SOUTH AUSTRALIAN WATER CORPORATION
Application purpose and description of use:
Variation of product registration and/or label approval to update label statements and include additional reservoir.
Description of data provided:
Data no
298743
Title
SA Water Response to the Outcome of the APVMA Environmental Assessment Module
Study date
24 October 2025
Auth party contact address
LEVEL 4, 250 VIC SQUARE ADELAIDE Australia
Data no
262155
Title
Wirrina WTP – Catchment Barrier Status Report
Study date
17 February 2023
Auth party contact address
LEVEL 4, 250 VIC SQUARE ADELAIDE Australia
Data no
264220
Title
Wirrina Catchment Golf Course Dam
Study date
23/9/19 and 17/10/19
Auth party contact address
LEVEL 4, 250 VIC SQUARE ADELAIDE Australia
Data no
262146
Title
Wirrina Water Treatment Plant – Local Catchment Environmental Assessment
Study date
24 August 2023
Auth party contact address
LEVEL 4, 250 VIC SQUARE ADELAIDE Australia
Data no
298742
Title
Raw Data_Figure 2A and Figure 3
Study date
19 November 2025
Auth party contact address
LEVEL 4, 250 VIC SQUARE ADELAIDE Australia
Date
Application Date
Application No
Application Number
138676
Product/Active constituent Name
Application Product Name
Nufarm Galaxy Herbicide
Application Date
Application Number
138676
Application Product Name
Nufarm Galaxy Herbicide
Application details
Product name:
Nufarm Galaxy Herbicide
Product number:
92149
Applicant Name:
NUFARM AUSTRALIA LIMITED
Application purpose and description of use:
Variation of product label approval to include aerial application for the same crops, weeds controlled, application rates and tank mixes as currently registered for ground boom application.
Active constituents:
Active constituent name
91686 - Pyrasulfotole
Description of data provided:
Data no
250061
Title
Nufarm Galaxy Herbicide Executive Summary
Study date
14 Feb 2023
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
250062
Title
Nufarm Galaxy Herbicide draft label marked up 14022023
Study date
13 Feb 2023
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
250060
Title
Environmental Technical Report for Application no. 131089, Permit 91161
Study date
1 June 2022
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
257005
Title
92149/138676 Nufarm Galaxy Herbicide - Response to S159 Notice of 28 June 2023
Study date
11 July 2023
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Date
Application Date
Application No
Application Number
138134
Product/Active constituent Name
Application Product Name
Salmonella Enterica ser. Enteritidis
Application Date
Application Number
138134
Application Product Name
Salmonella Enterica ser. Enteritidis
Application details
Product name:
Salmonella Enterica ser. Enteritidis
Product number:
93161
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction with approval of two active constituents.
Date
Application Date
Application No
Application Number
138135
Product/Active constituent Name
Application Product Name
AviPro Salmonella Duo Live Vaccine
Application Date
Application Number
138135
Application Product Name
AviPro Salmonella Duo Live Vaccine
Application details
Product name:
AviPro Salmonella Duo Live Vaccine
Product number:
93162
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction with approval of two active constituents.
Description of data provided:
Data no
248321
Title
Study no.: 148/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248298
Title
Study no.: 67/01 B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248275
Title
Study no.: 279/05
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248252
Title
Batch record-200312-2c03
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248229
Title
Manufacturing description
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261812
Title
Impact of maternal antibodies on the efficacy of immunisation of chicks with live Salmonella vaccines
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291295
Title
Import permit
Study date
20DEC2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248244
Title
Product development
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248292
Title
Report on the monitoring of human and environmental isolates of Salmonella enteritidis and Salmonella typhimurium
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248304
Title
PSUR Vac E
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248338
Title
Oral Administration of the Salmonella Typhimurium Vaccine Strain NaI2/Rif9/Rtt to Laying Hens at Day of Hatch Reduces Shedding and Caecal Colonization of Salmonella 4, 12:i:-, the Monophasic Variant of Salmonella Typhimurium
Study date
2015
Auth party contact address
-
Data no
254982
Title
Minireview: Antibiotic-supersusceptible mutants of Escherichia coli and Salmonella Typhimurium.
Study date
1993
Auth party contact address
-
Data no
248344
Title
Salmonella infections: immune and non-immune protection with vaccines
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248238
Title
Part 2 Overview
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248261
Title
Study no.: 13/06
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261806
Title
Protocol vials and stoppers
Study date
2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248212
Title
Bacterial live vaccines with graded level of attenuation achieved by antibiotic resistance mutations: transduction experiments on the functional unit of resistance, attenuation and further accompanying markers
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270319
Title
ADVERSE EVENT SUMMARY REPORT - AviPro Salmonella Duo Live Vaccine
Study date
30 Jan 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248281
Title
Study no.: 521/94 A
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248355
Title
Report(s) on the monitoring of human and environmental isolates of Salmonella enteritidis and Salmonella typhimurium
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248232
Title
Validation report 0-0060-VR-92637
Study date
04 May 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248361
Title
Study no.: 97/06
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278657
Title
13835-93162 e-label Version 3
Study date
September 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248375
Title
PSUR Vac E
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291298
Title
Rapid real-time PCR methods to distinguish Salmonella Enteritidis wildtype field isolates from vaccine strains Salmovac SE/Gallivac SE and AviPro SALMONELLA VAC E
Study date
March 2015
Auth party contact address
-
Data no
248318
Title
Study no.: 294/05
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248324
Title
Studies of contamination of three broiler breeder houses with Salmonella enteritidis before and after cleansing and disinfection
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261800
Title
Specification cap
Study date
30 June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
289185
Title
Response App 2-3c batch-record Salm VacT English language
Study date
29 Nov 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248218
Title
0-0062-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248367
Title
Study no.: 66/01 B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
254985
Title
2023-06-19 Elanco Salmonella Resp to s159 notice
Study date
2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291292
Title
Vacuum testing procedure Engligh language
Study date
14DEC2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
254979
Title
Common themes among bacteriophage-encoded virulence factors and diversity among the bacteriophages involved.
Study date
2002
Auth party contact address
-
Data no
261809
Title
SPF-certification relating to Study 85/01
Study date
7 March 2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248255
Title
Study no.: 85/01
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248301
Title
Bacterial live vaccines with graded level of attenuation achieved by antibiotic resistance mutations: transduction experiments on the functional unit of resistance, attenuation and further accompanying markers
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270322
Title
138135-93162 e-label version 2
Study date
8 April 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248241
Title
Quality Certificate
Study date
October 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248341
Title
Review article: Vaccination and early protection against non-host-specific Salmonella serotypes in poultry: exploitation of innate immunity and microbial activity
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248347
Title
Part 6 overview AviPro Salmonella Duo
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248295
Title
Study no.: 399/05
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261803
Title
Sealing procedure
Study date
30 May 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248215
Title
Expert report
Study date
16 December 2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248264
Title
Study no.: 372/01
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248235
Title
Starting materials of biological origin
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248335
Title
Oral Vaccination with a Live Salmonella Enteritidis/Typhimurium Bivalent Vaccine in Layers Induces Cross-protection Against Caecal and Internal Organ Colonization by a Salmonella Infantis Strain
Study date
2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248284
Title
Study no.: 525/94
Study date
1995
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248358
Title
Study no.: H 01/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248209
Title
Master seed S.T.
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248258
Title
Study no.: 147/05
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248307
Title
Study no.: 244/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270316
Title
Ph. Eur. 2521E
Study date
2013
Auth party contact address
-
Data no
248315
Title
Study no.: 97/06
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248327
Title
Permit Application ID 0003267036
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
289188
Title
Response App 2-3f Homogenous mixing English language
Study date
29 Nov 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248278
Title
Study no.: LAH2001-1
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248364
Title
Diagnostic, epidemiology and prevention of Salmonella Typhimurium and Salmonella Enteritidis infections in ducks considering in particular the immunoprophylaxis with live vaccines
Study date
18 August 1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291301
Title
138146-93168 e-label version 4
Study date
19 June 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248272
Title
PDV/5101-ER/2011-05-04
Study date
2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248221
Title
0-0110-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248250
Title
Stress stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291293
Title
GMP Certificate
Study date
19JUN2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248273
Title
Study no.: 37/05
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248227
Title
GMP certificate
Study date
15 November 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248256
Title
Study no.: 262/02
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
254980
Title
Vaccination against Salmonella Enteritidis in Dutch commercial layer flocks with a vaccine based on a live Salmonella Gallinarum 9R strain: evaluation of efficacy, safety, and performance of serologic Salmonella tests.
Study date
2001
Auth party contact address
-
Data no
248290
Title
Communications from Robert H Davies, Weybridge
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248350
Title
PSUR Vac T
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248342
Title
Review: The long view: Salmonella - the last forty years
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261818
Title
Monograph 2521
Study date
04/2013
Auth party contact address
-
Data no
248296
Title
Study no.: 97/06
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270317
Title
ADVERSE EVENT SUMMARY REPORT - AviPro Salmonella Vac T Live Vaccine
Study date
24 Jan 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248310
Title
Expert report on the safety of a Salmonella vaccine strain for calves and piglets
Study date
1992
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261804
Title
Homogenous mixing
Study date
20 August 2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248216
Title
0-0115-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248287
Title
Diagnostic, epidemiology and prevention of Salmonella Typhimurium and Salmonella Enteritidis infections in ducks considering in particular the immunoprophylaxis with live vaccines.
Study date
1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248259
Title
Study no.: 148/05
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248330
Title
Clonal Structure and Variation in Virulence of Salmonella Enteritidis Isolated from Mice, Chickens, and Humans
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248336
Title
Salmonella enterica Serotype Typhimurium and its Host-Adapted Variants
Study date
2002
Auth party contact address
-
Data no
248236
Title
In process control tests
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248353
Title
Report: Communications from Robert H Davies, Weybridge
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248359
Title
Expert report on the safety of a Salmonella vaccine strain for calves and piglets
Study date
1992
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248210
Title
Working seed S.E.
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248267
Title
Study no.: 60/96
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248279
Title
Study no.: 188/11
Study date
2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248316
Title
Study no.: 521/94 A
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261798
Title
Specification vial
Study date
5 January 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248373
Title
Bacterial live vaccines with graded level of attenuation achieved by antibiotic resistance mutations: transduction experiments on the functional unit of resistance, attenuation and further accompanying markers
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248224
Title
Batch record-200312-2c03
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
289189
Title
20231129 Salmonella vaccines-response cover letter
Study date
29 Nov 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261815
Title
Testing Standard 0-0171-TS-BA.01
Study date
20 January 2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248322
Title
Study no.: 67/01B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248299
Title
Infection model of Salmonella Enteritidis and S. Typhimurium in Pekin ducks (Anas playrhynchos)
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248276
Title
Study no.: 294/05
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
289183
Title
Response App 2-3a Batch-record Salm Duo English language
Study date
29 Nov 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248253
Title
Batch record-200401-3c
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291296
Title
20250704 Response doc
Study date
July 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248230
Title
Manufacturing validation summary
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278655
Title
20240923 Response doc-Sept 2024
Study date
23 September 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248339
Title
Salmonella Infections: Immune and Non-immune Protection with Vaccines
Study date
2007
Auth party contact address
-
Data no
248247
Title
Long term stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248293
Title
Lohmann Animal Health Report on the fourth and last six-month monitoring period of Salmonella enteritidis isolates
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248333
Title
Advances in typing and identification of foodborne pathogens
Study date
2021
Auth party contact address
-
Data no
248213
Title
Development of S.E. strain
Study date
March 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248239
Title
Particulars
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261801
Title
Batch-record Salm Duo
Study date
14 February 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270314
Title
Response App 2-12 G-A
Study date
20 March 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248233
Title
Starting materials listed in pharmacopoeias
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248356
Title
Lohmann Animal Health Report on the fourth and last six-month monitoring period of Salmonella enteritidis isolates
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261807
Title
Chem & Manuf response to s159(1)(a) Notice of 25 July 2023
Study date
October 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248313
Title
Study no.: 0-0197-TS-BA.01
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248362
Title
Study no.: 244/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278658
Title
13846-93168 e-label Version 3
Study date
September 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
289186
Title
Response App 2-3d Filling-closing procedure English language
Study date
29 Nov 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248370
Title
Ducks Safety 2005
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248270
Title
Part 8 Overview AviPro Salmonella Duo
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248319
Title
Study: Gantois et al., 2006
Study date
2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261816
Title
5.2.6. Evaluation of Safety of Veterinary Vaccines and Immunosera
Study date
04/2024
Auth party contact address
-
Data no
248225
Title
Batch record-b052600-03
Study date
13 February 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
289184
Title
Response App 2-3b batch-record Salm VacE English language
Study date
29 Nov 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278656
Title
13835-93162 e-label Version 3
Study date
September 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248254
Title
Batch record-9475400
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248231
Title
Validation report 0-0063-VR-111-01
Study date
23 November 2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248208
Title
Master seed S.E.
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291291
Title
Vacuum testing procedure
Study date
14DEC2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270323
Title
138146-93168 e-label version 2
Study date
8 April 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261810
Title
Wird die Wirksamkeit der Immunisierung von K ? ken mit Salmonella-Lebendimpfstoffen durch maternale Anik?rper beeinflusst?
Study date
2002
Auth party contact address
-
Data no
248302
Title
Study: Salm 01/05
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248348
Title
Study no.: Salm 01/05
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248242
Title
Closure
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248248
Title
Relocation stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248294
Title
Lohmann Animal Health Report on the fourth and last six-month monitoring period of Salmonella Typhimuriumisolates
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248357
Title
Report on the fourth semester of monitoring Salmonella Typhimurium isolates
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248285
Title
Study no.: 01/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248334
Title
Protection Conferred by a Live Salmonella Enteritidis Vaccine Against Fowl Typhoid in Laying Hens
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261802
Title
Filling-closing procedure
Study date
30 September 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248234
Title
Starting materials of non-biological origin
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248308
Title
Study no.: 525/94
Study date
1995
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278659
Title
Expert Report 4/6/2024
Study date
4 June 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248328
Title
PAA - Salmonella Vaccines Registration in Australia
Study date
2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248314
Title
PSUR Vac T
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248265
Title
Study no.: 152/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248271
Title
Expert report on the possible transferability of plasmids between cells of Salmonella VacE and Salmonella VacT during co-cultivation
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291302
Title
Design and Validation of RT-PCR Assays to Differentiate Salmonella Vaccine Strains from Wild-Type Field Isolates
Study date
2024
Auth party contact address
-
Data no
248365
Title
Study no.: 0-0197-TS-BA.01
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248371
Title
Study no.: 148/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248222
Title
Batch to batch consistency
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261796
Title
Salmonella Enteritidis WSB _ CoA
Study date
11 December 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
289187
Title
Response App 2-3e Sealing procedure English language
Study date
29 Nov 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248274
Title
Study no.: Ducks Safety 2005
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248345
Title
PAA - APVMA Written assistance
Study date
2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248228
Title
Manufacturing flow chart
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248251
Title
Batch record 200308-1c03
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261813
Title
Safety & Efficacy response to s159(1)(a) Notice of 25 July 2023
Study date
Oct 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248351
Title
Expert Report for the occurrences in Germany of Salmonella strains in humans, which correspond to the live vaccines TAD Salmonella vac T and TAD Salmonella vac
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248291
Title
Report on the monitoring of human and environmental isolates of Salmonella enteritidis and Salmonella typhimurium
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248337
Title
Genome Variation and Molecular Epidemiology of Salmonella enterica Serovar Typhimurium Pathovariants
Study date
2018
Auth party contact address
-
Data no
248245
Title
Stability overview and conclusion
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
254983
Title
Alterations in outer membrane permeability.
Study date
1984
Auth party contact address
-
Data no
261819
Title
Cover letter for response to s159(1)(a) Notice of 25 July 2023
Study date
Oct 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248262
Title
Study no.: Gantois et al.
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248311
Title
Diagnostic, epidemiology and prevention of Salmonella Typhimurium and Salmonella Enteritidis infections in ducks considering in particular the immunoprophylaxis with live vaccines
Study date
1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248288
Title
Expert Report for the occurrences in Germany of Salmonella strains in humans, which correspond to the live vaccines TAD Salmonella vac T and TAD Salmonella vac E.
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248354
Title
Report(s) on the monitoring of human and environmental isolates of Salmonella enteritidis and Salmonella typhimurium
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270320
Title
20240411 Cover letter Salmonella vaccines
Study date
11 April 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248211
Title
Working seed S.T.
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248305
Title
PSUR Vac T
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248282
Title
Study no.: 66/01 B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248331
Title
The Transformation of Reference Microbiology Methods and Surveillance for Salmonella With the Use of Whole Genome Sequencing in England and Wales
Study date
2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248268
Title
M. Voss, 1996 (Study: Lohmann Information 3/96)
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291299
Title
13835-93162 e-label version 4
Study date
19 June 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261799
Title
Specification stopper
Study date
30 June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248325
Title
Study no.: 399/05
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248374
Title
Studies of contamination of three broiler breeder houses with Salmonella enteritidis before and after cleansing and disinfection
Study date
1996
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248219
Title
0-0060-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248317
Title
Study no.: 66/01 B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248368
Title
Study no.: 294/05
Study date
2005
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248369
Title
Study No.: Gantois et al.
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248346
Title
Pre-application Assistance: APVMA Written Assistance
Study date
2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248323
Title
Bacterial live vaccines with graded level of attenuation achieved by antibiotic resistance mutations: transduction experiments on the functional unit of resistance, attenuation and further accompanying markers
Study date
1998
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261814
Title
Vaccines for Veterinary Use (Supplement 7.7)
Study date
September 2021
Auth party contact address
-
Data no
248300
Title
Salmonella infection in a commercial line of ducks; Experimental studies on virulence, intestinal colonization and immune protection
Study date
1999
Auth party contact address
-
Data no
248277
Title
Study no.: Salmonella 101
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248340
Title
Vaccination and Early Protection Against Non-host-specific Salmonella Serotypes in Poultry: Exploitation of Innate Immunity and Microbial Activity
Study date
2005
Auth party contact address
-
Data no
248352
Title
Expert Report on the incidence of Salmonella strains in humans in Germany which correspond to the live vaccines AviPro Salmonella vac T and AviPro Salmonella vac E
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270321
Title
20240411 Response doc-April 2024
Study date
11 April 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248246
Title
Frozen storage stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
254984
Title
Stable Salmonella live vaccine strains with two or more attenuating mutations and any desired level of attenuation
Study date
1990
Auth party contact address
-
Data no
248240
Title
Vial
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248214
Title
Development of S.T. strain
Study date
May 2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248263
Title
Study no.: 485/99
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248312
Title
Study no.: Salm 01/05
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248283
Title
Study no.: 244/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248332
Title
What WGS Reveals about Salmonella enterica subsp. Enterica in Wildlife in Germany
Study date
2021
Auth party contact address
-
Data no
261808
Title
Study No. 92/92
Study date
19 June 1992
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248257
Title
Study no.: 278/02
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248306
Title
Part 7 Overview AviPro Salmonella Duo
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270315
Title
Ph. Eur. 2520E
Study date
2013
Auth party contact address
-
Data no
248363
Title
Study no.:525/94
Study date
1995
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291300
Title
138142-93166 e-label version 4
Study date
19 June 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248326
Title
Part 1 Application Overview
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248320
Title
Study: no.: Ducks Safety 2005
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248220
Title
0-0063-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248269
Title
Study: Salm 01/05
Study date
2008
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248297
Title
Study no.: 148/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291294
Title
20250729 CMC Response document
Study date
July 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248249
Title
In use stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248226
Title
Batch record-g039700-01
Study date
29 December 2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248303
Title
Duck-Tec Bruterei GmbH (Administration of AviPro Salmonella Vac E and AviPro Salmonella Vac T to Peking ducks under field conditions
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270324
Title
138142-93166 e-label version 2
Study date
8 April 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261811
Title
Successful vaccination of layer pullets during the first days of life using a bivalent live vaccine against Salmonella Enteritidis and Salmonella Typhimurium
Study date
September 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248349
Title
PSUR Vac E
Study date
2009
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248289
Title
Expert Report on the incidence of Salmonella strains in humans in Germany which correspond to the live vaccines AviPro Salmonella vac T and AviPro Salmonella vac E
Study date
2010
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248243
Title
Quality Certificate
Study date
November 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
254981
Title
Development of live Salmonella vaccines optimally attenuated for chickens.
Study date
1997
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261817
Title
Monograph 2520
Study date
04/2013
Auth party contact address
-
Data no
248343
Title
Salmonella in Domestic Animals (2nd edition
Study date
2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248286
Title
Study: Hannover Veterinary College (Expert report on the safety of a Salmonella vaccine strain for calves and piglets)
Study date
1992
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248309
Title
Study no.: 01/99
Study date
1999
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
270318
Title
ADVERSE EVENT SUMMARY REPORT - AviPro Salmonella Vac E Live Vaccine
Study date
25 Jan 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248237
Title
Control tests on the finished product
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248360
Title
Study no.: 399/05
Study date
2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248260
Title
Study no.: 147/06
Study date
2007
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248329
Title
Response to: Pre-Application Assistance APVMA Written Assistance Report, questions from pages 6 to 7
Study date
September 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261805
Title
Residual moisture VR Salm Duo
Study date
November 2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248280
Title
Study no.: V2011/07
Study date
2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261797
Title
Salmonella Typhimurium WSB _ CoA
Study date
14 April 2015
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
291297
Title
Technical Bulletin: A real-time PCR-based method to distinguish the live AviPro? SALMONELLA VAC E, AviPro? SALMONELLA VAC T and AviPro? SALMONELLA DUO vaccine strains from S. Enteritidis and S. Typhimurium field strains
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248366
Title
Study no.: 521/94 A
Study date
2000
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248372
Title
Study no.: 67/01 B
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248217
Title
0-0061-TS-BA
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248223
Title
Batch record-200308-1c03
Study date
29 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248266
Title
Study no.: 250/93
Study date
2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
138136
Product/Active constituent Name
Application Product Name
Salmonella Enterica ser. Typhimurium
Application Date
Application Number
138136
Application Product Name
Salmonella Enterica ser. Typhimurium
Application details
Product name:
Salmonella Enterica ser. Typhimurium
Product number:
93163
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction with approval of two active constituents.
Date
Application Date
Application No
Application Number
138142
Product/Active constituent Name
Application Product Name
AviPro Salmonella Vac E Live Vaccine
Application Date
Application Number
138142
Application Product Name
AviPro Salmonella Vac E Live Vaccine
Application details
Product name:
AviPro Salmonella Vac E Live Vaccine
Product number:
93166
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction
with approval of an active constituent.
Description of data provided:
Data no
248722
Title
In-use stability report
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248699
Title
Appendix 1-0 Part 1 overview AviPro Salmonella Vac E
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248710
Title
Starting materials of biological origin
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248716
Title
Batch record-A059400
Study date
09 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248702
Title
Particulars
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261823
Title
Residual moisture VR Salm VacE
Study date
March 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248719
Title
Stability overview and conclusion
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248713
Title
Control tests on the finished product
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248708
Title
Validation report 0-0060-vr-ba01
Study date
03 Jan 2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248714
Title
Batch to batch consistency
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248725
Title
Batch record-6093700
Study date
May 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248705
Title
Manufacturing description
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248717
Title
Batch record-A059500
Study date
10 March 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248711
Title
Master seed S.E.
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248703
Title
Product development
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248726
Title
Appendix 8-0 Part 8 overview Salmonella Vac E
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261822
Title
Batch record Salm VacE
Study date
14 February 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248720
Title
Long term stability report
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248706
Title
Manufacturing validation summary
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248712
Title
Working seed S.E.
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248723
Title
Stress stability report
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248700
Title
Permit Application ID 0003267036
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248709
Title
Validation report 0-0060-vr-91998-01
Study date
25 April 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248701
Title
Part 2 Overview
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248724
Title
Batch record-6093500
Study date
May 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248718
Title
Batch record-G033600
Study date
29 November 2016
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248704
Title
Manufacturing flow chart
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248721
Title
Relocation stability report
Study date
July 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248707
Title
Validation report 0-0063-vr-110-01-01
Study date
21 March 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248715
Title
Batch record-5062300
Study date
May 2019
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
138146
Product/Active constituent Name
Application Product Name
AviPro Salmonella Vac T Live Vaccine
Application Date
Application Number
138146
Application Product Name
AviPro Salmonella Vac T Live Vaccine
Application details
Product name:
AviPro Salmonella Vac T Live Vaccine
Product number:
93168
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Registration of a veterinary vaccine (lyophilised for reconstitution) for active immunisation of chickens, in conjunction with approval of an active constituent (secondary application).
Description of data provided:
Data no
248676
Title
Control tests on the finished product
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248693
Title
Batch record-5077000
Study date
11 March 2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248667
Title
Manufacturing flow chart
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248673
Title
Starting materials of biological origin
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248679
Title
Batch record-9101100
Study date
9 May 2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248687
Title
Stress stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248690
Title
Batch record-B031700
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248670
Title
Validation report 0-0060-vr-92059-01
Study date
25 April 2012
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248674
Title
Master seed S.T.
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248682
Title
Batch record-B031700
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261824
Title
Residual moisture VR Salm VacT
Study date
March 2017
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248691
Title
Batch record-5076600
Study date
1 March 2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248688
Title
Batch record-B017800
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248665
Title
Particulars
Study date
January 2020
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248671
Title
Validation report 0-0060-vr-ba01
Study date
03 January 2001
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248694
Title
Part 8 overview AviPro Salmonella Vac T
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248685
Title
Intermediate storage stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248662
Title
Part 1 application overview AviPro Salmonella Vac T
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248668
Title
Manufacturing description
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248680
Title
Batch record-B017800
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248686
Title
In-use stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248669
Title
Manufacturing validation summary
Study date
June 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248663
Title
Permit Application ID 0003267036
Study date
2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248677
Title
Batch to batch consistency
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248683
Title
Stability overview and conclusion
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248692
Title
Batch record-5076800
Study date
11 March 2013
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248689
Title
Batch record-B024100
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248666
Title
Product development
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248678
Title
Batch record-6005400
Study date
26 April 2006
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248684
Title
Long term stability report
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
261825
Title
Batch-record Salm VacT
Study date
14 February 2023
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248675
Title
Working see S.T.
Study date
August 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248681
Title
Batch record-B024100
Study date
24 October 2011
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248672
Title
Validation report 0-0063-vr-111-01
Study date
29 March 2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
248664
Title
Part 2 Overview
Study date
December 2022
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
134834
Product/Active constituent Name
Application Product Name
Royal Canin Recovery Liquid Canine Feline
Application Date
Application Number
134834
Application Product Name
Royal Canin Recovery Liquid Canine Feline
Application details
Product name:
Royal Canin Recovery Liquid Canine Feline
Product number:
92202
Applicant Name:
ROYAL CANIN AUSTRALIA PTY LTD
Application purpose and description of use:
The purpose of this application is to register a liquid enteral nutrition product, 'Royal Canin Recovery Liquid Canine Feline', indicated for 'vet only' use in a critical care environment for dogs and cats.
Description of data provided:
Data no
234945
Title
Finished product batch analysis
Study date
September 2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246306
Title
Claim substantiation - Renal Feline
Study date
2016
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234936
Title
Certificates of Analysis_exempt active constituents
Study date
2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246309
Title
Claim substantiation - Recovery
Study date
2016
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234942
Title
In-process controls
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246303
Title
Kerry Inc. potable water source
Study date
October 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234933
Title
Critical care liquid diets product guide
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234953
Title
Scientific Guide
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234939
Title
Certificates of Analysis_excipients
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246300
Title
Recovery 15 month stability
Study date
November 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234928
Title
Release & expiry specifications
Study date
January 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234934
Title
Certificate of Analysis_finished product
Study date
October 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234940
Title
GMP evidence
Study date
October 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246301
Title
Gastrointestinal 14.5 month stability
Study date
April 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234948
Title
Product verification testing
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234931
Title
MPL artwork
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234951
Title
ICU Product Guide
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246312
Title
Ingredient classification outcome
Study date
May 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234937
Title
Certificates of Analysis_pharmacopoeial grade active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234949
Title
Target Animal Safety & Efficacy summary
Study date
March 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234932
Title
Nutritional protocol guidelines
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246313
Title
Silliker site certification
Study date
July 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234952
Title
Critical Care Guidelines
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234946
Title
Analytical procedures
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246307
Title
Vet education webinar
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234935
Title
Chemistry & Manufacture summary
Study date
March 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234929
Title
PAA written correspondence
Study date
August 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246310
Title
Claim substantiation - Gastrointestinal
Study date
2016
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234943
Title
Packaging specifications
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246304
Title
Lutein CoA documentation
Study date
2018
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234947
Title
Stability data
Study date
August 2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246308
Title
GIT tract scientific presentation
Study date
April 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234930
Title
IMPL cluster artwork
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246299
Title
Renal Canine 15.25 month stability
Study date
October 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246311
Title
PAA advice - DCPAA2-07426157A
Study date
August 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234938
Title
Certificates of Analysis_non-pharmacopoeial grade active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234944
Title
Quality control documentation
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246305
Title
Claim substantiation - Renal Canine
Study date
2016
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234950
Title
AAFCO 2020 Nutritional Profiles
Study date
2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234941
Title
Manufacturing flowchart
Study date
December 2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
246302
Title
Appendix 2-11 replacement documentation
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Date
Application Date
Application No
Application Number
134836
Product/Active constituent Name
Application Product Name
Royal Canin Gastrointestinal Low Fat Liquid Canine
Application Date
Application Number
134836
Application Product Name
Royal Canin Gastrointestinal Low Fat Liquid Canine
Application details
Product name:
Royal Canin Gastrointestinal Low Fat Liquid Canine
Product number:
92204
Applicant Name:
ROYAL CANIN AUSTRALIA PTY LTD
Application purpose and description of use:
The purpose of this application is to register a liquid enteral nutrition product, 'Royal Canin Gastrointestinal Low Fat Liquid Canine', indicated for 'vet only' use in a critical care environment for dogs.
Description of data provided:
Data no
235005
Title
Packaging specifications
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234999
Title
Certificates of Analysis_pharmacopoeial grade active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235002
Title
GMP evidence
Study date
October 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235008
Title
Analytical procedures
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234996
Title
Certificate of Analysis_finished product
Study date
June 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235014
Title
Critical Care Guidelines
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235003
Title
Manufacturing flowchart
Study date
December 2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234997
Title
Chemistry & Manufacture summary
Study date
March 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234991
Title
PAA written correspondence
Study date
August 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234994
Title
Nutritional protocol guidelines
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235011
Title
Target Animal Safety & Efficacy summary
Study date
March 2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235000
Title
Certificates of Analysis_non-pharmacopoeial grade active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234995
Title
Critical care liquid diets product guide
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235012
Title
AAFCO 2020 Nutritional Profiles
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235009
Title
Stability data
Study date
March 2019
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235015
Title
Scientific Guide
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235006
Title
Quality control documentation
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234998
Title
Certificates of Analysis_exempt active constituents
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234992
Title
IMPL cluster artwork
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234993
Title
MPL artwork
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235010
Title
Product verification testing
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235007
Title
Finished product batch analysis
Study date
April 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235001
Title
Certificates of Analysis_excipients
Study date
2022
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235013
Title
ICU Product Guide
Study date
2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
235004
Title
In-process controls
Study date
December 2020
Auth party contact address
Level 23 727 Collins Street Melbourne Australia
Data no
234990
Title
Release and expiry specifications
Study date
January 2021
Auth party contact address
Level 23 727 Collins Street Melbourne Australia