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
142732
Product/Active constituent Name
Application Product Name
NOVAGIB Plant Growth Regulator
Application Date
Application Number
142732
Application Product Name
NOVAGIB Plant Growth Regulator
Application details
Product name:
NOVAGIB Plant Growth Regulator
Product number:
94544
Applicant Name:
FINE AGROCHEMICALS LIMITED
Application purpose and description of use:
Registration of a 10g/L gibberellin A4&A7 liquid soluble concentrate formulation product for the control of weather-induced russeting in apples and to aid in improving apple shape.
Reference details:
53540 - PERLAN - PLANT GROWTH REGULATOR
85191 - EuroChem GA4&7 Plant Growth Regulator
Active constituents:
Active constituent name
87120 - Gibberellin A4 and Gibberellin A7
Description of data provided:
Data no
266646
Title
Validation Data GA4
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266647
Title
Validation Data GA7
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266644
Title
Active Composition
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266645
Title
Active CoA
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266648
Title
Stability 1
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266649
Title
Stability 2
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266643
Title
SDS Non-actives
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266642
Title
Part 2 Chemistry and Manufacturing Dossier
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266671
Title
Efficacy and Crop Safety Apples 1
Study date
2005
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266672
Title
Efficacy and Crop Safety Apples 2
Study date
2004
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266673
Title
Efficacy and Crop Safety Apples 3
Study date
2005
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266674
Title
Efficacy and Crop Safety Apples 4
Study date
2005
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266675
Title
Efficacy and Crop Safety Apples 5
Study date
2003
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266676
Title
Efficacy and Crop Safety Apples 6
Study date
2003
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266677
Title
Efficacy and Crop Safety Apples 7
Study date
2021
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266678
Title
Efficacy and Crop Safety Apples 8
Study date
2021
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266679
Title
Efficacy and Crop Safety Apples 9
Study date
2022
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266680
Title
Efficacy and Crop Safety Apples 10
Study date
2022
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266681
Title
Efficacy and Crop Safety Apples 11
Study date
2010
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266682
Title
Efficacy and Crop Safety Apples 12
Study date
2009
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266683
Title
Efficacy and Crop Safety Apples 13
Study date
2010
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266684
Title
Efficacy and Crop Safety Apples 14
Study date
2011
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266685
Title
Efficacy and Crop Safety Apples 15
Study date
2003
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266686
Title
Efficacy and Crop Safety Apples 16
Study date
2017
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
283830
Title
RESPONSE TO EFFICACY REVIEW ? SECTION 159(1)(a) NOTICE (APVMA no. 94544, APPLICATION NO. 142732)
Study date
30 January 2025
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
283831
Title
Annex 1 to the document "RESPONSE TO EFFICACY REVIEW ? SECTION 159(1)(a) NOTICE (APVMA no. 94544, APPLICATION NO. 142732)"
Study date
30 January 2025
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
283832
Title
UNECE STANDARD FFV-50 concerning the marketing and commercial quality control of APPLES 2023 EDITION
Study date
15 March 2024
Auth party contact address
-
Data no
283833
Title
Aussie Apples Guidelines, specifications and product description language.
Study date
25 January 2016
Auth party contact address
-
Data no
283834
Title
Development of comparable agro-climatic zones for the international exchange of data on the efficacy and crop safety of plant protection products
Study date
2005
Auth party contact address
-
Data no
283835
Title
COMPARISON OF CLIMATIC CONDITIONS
Study date
30 January 2025
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266670
Title
Part 8 Efficacy and Safety
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266641
Title
Executive Summary
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266662
Title
Part 6 OHS Dossier
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266663
Title
EFSA Peer Review Active
Study date
2012
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266664
Title
Active CoA
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266665
Title
Active SDS
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266666
Title
Product SDS
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266667
Title
Non-actives SDS
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266668
Title
Occupational Worker Exposure Calculator
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266669
Title
Re-entry Exposure Calculator
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266656
Title
Acute Dermal Study
Study date
1997
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266658
Title
Eye Irritation Study
Study date
1997
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266657
Title
Acute Inhalation Study
Study date
1997
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266661
Title
Mutagenicity
Study date
2017
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266655
Title
Acute Oral Study
Study date
1997
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266659
Title
Skin Irritation Study
Study date
1997
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266660
Title
Skin Sensitisation
Study date
1997
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266650
Title
Part 3 Toxicology Dossier
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266651
Title
EFSA Peer Review Active
Study date
2012
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266652
Title
Active SDS
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266653
Title
Product SDS
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Data no
266654
Title
SDS Non-actives
Study date
2024
Auth party contact address
HILL END HOUSE WHITTINGTON, WORCESTER United Kingdom
Date
Application Date
Application No
Application Number
142754
Product/Active constituent Name
Application Product Name
Pyroxasulfone
Application Date
Application Number
142754
Application Product Name
Pyroxasulfone
Application details
Product name:
Pyroxasulfone
Active name:
Pyroxasulfone
Applicant Name:
ZHEJIANG ZHONGSHAN CHEMICAL INDUSTRY GROUP CO.,LTD
Application purpose and description of use:
Approval of Pyroxasulfone for use in agricultural chemical products.
Description of data provided:
Data no
266800
Title
Qualitative and Quantitative Profile of Pyroxasulfone Technical (Five Batch Analysis).
Study date
31 October 2023
Data no
266798
Title
Manufacturing Process of Pyroxasulfone Technical Grade Active Substance.
Study date
22 November 2023
Data no
266799
Title
Declaration Of Composition
Study date
31 January 2024
Data no
266801
Title
Pyroxasulfone Technical
Study date
31 January 2024
Data no
266797
Title
Executive Summary
Study date
February 2024
Date
Application Date
Application No
Application Number
143085
Product/Active constituent Name
Application Product Name
GLYDE MOBILITY CHEWS FOR DOGS
Application Date
Application Number
143085
Application Product Name
GLYDE MOBILITY CHEWS FOR DOGS
Application details
Product name:
GLYDE MOBILITY CHEWS FOR DOGS
Product number:
69858
Applicant Name:
PARNELL TECHNOLOGIES PTY LTD
Application purpose and description of use:
Minor change in active substance proposition and change of excipients of Herbal and marine-derived products (Complementary animal health product).
Active constituents:
Active constituent name
86486 - GLUCOSAMINE HYDROCHLORIDE
Active constituent name
86479 - CHONDROITIN SULPHATE SODIUM
Description of data provided:
Data no
278208
Title
Batch Processing Instructions
Study date
16 June 23
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
278209
Title
Manufacturing Batch Record
Study date
17 June 24
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
278210
Title
Validation Protocal IOQ for Chews
Study date
2 May 24
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
278211
Title
Validation Protocol PQ for Chews production and packaging line
Study date
13 June 24
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
278212
Title
Validation Protocol for Chews Compounding & Packaging
Study date
14 June 24
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
278213
Title
Validation Protocol IOQ for Chews-1
Study date
2 May 24
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
278214
Title
Validation Protocol IOQ for Chews-2
Study date
15 May 24
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
278215
Title
Environmental Monitoring of Cleanrooms
Study date
17 Feb 23
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
278216
Title
Airflow Monitoring of Production Clean Rooms
Study date
27 May 24
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
278217
Title
Routine Temperature Monitoring of Production Clean Rooms
Study date
12 June 24
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
278218
Title
Cleaning and Sanitation of Production Cleanrooms
Study date
24 June 24
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
267676
Title
Proposed Product Formulation
Study date
03-Nov-2022
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
267677
Title
Flow Diagram- Current
Study date
2023
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
278221
Title
Inspection Exit Notice
Study date
1 May 2023
Data no
278222
Title
Email response from manufacturer
Study date
13 June 2024
Data no
278223
Title
Establishment Licence
Study date
5 September 2023
Data no
267681
Title
Proposed Process flow chart of the Glyde Chews
Study date
2024
Data no
278224
Title
Response to notice - Formulation clarification
Study date
11 September 2024
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
267675
Title
APVMA response on Parnell initial assessment for the minor update of Glyde chews formulation- (Complementary animal health products)
Study date
8 December 2023
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
278219
Title
Response to notice - GMP clarification
Study date
25 June 24
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
278220
Title
Final response to notice - GMP clarification
Study date
1 Aug 24
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
267679
Title
Good Manufacturing Practice Certificate
Study date
14 December 2023
Data no
267680
Title
Authorized signatures for CPP and GMP certification
Study date
20 November 2023
Data no
267674
Title
Cover letter_Item 12_Glyde Chews_Minor Formulation update
Study date
4 March 2024
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Data no
267678
Title
Cover letter_Item 12_Glyde Chews_Overseas Site Inclusion
Study date
5 March 2024
Auth party contact address
4/476 GARDENERS ROAD ALEXANDRIA Australia
Date
Application Date
Application No
Application Number
143091
Product/Active constituent Name
Application Product Name
Fluopyram
Application Date
Application Number
143091
Application Product Name
Fluopyram
Application details
Product name:
Fluopyram
Active name:
Fluopyram
Applicant Name:
YIFAN BIOTECHNOLOGY GROUP CO., LTD.
Application purpose and description of use:
Approval of Fluopyram for use in agricultural chemical products.
Description of data provided:
Data no
267693
Title
Preliminary Analysis and Enforcement Method of Fluopyram Technical ??? Validation of Analytical Methodology for the Assay of Active Ingredient, Impurities And Subsequent Five Batch Analysis of Fluopyram Technical
Study date
22 December 2023
Auth party contact address
No. 555, Changan Road Yaoxi Subdistrict Wenzhou City, Zhejiang Wenzhou City, Zhejiang China
Data no
267691
Title
Part I: Manufacturing Process of Fluopyram Technical
Study date
January 2024
Auth party contact address
No. 555, Changan Road Yaoxi Subdistrict Wenzhou City, Zhejiang Wenzhou City, Zhejiang China
Data no
267692
Title
Declaration of Composition
Study date
17 January 2024
Auth party contact address
No. 555, Changan Road Yaoxi Subdistrict Wenzhou City, Zhejiang Wenzhou City, Zhejiang China
Data no
267694
Title
Fluopyram Technical
Study date
29 February 2024
Auth party contact address
No. 555, Changan Road Yaoxi Subdistrict Wenzhou City, Zhejiang Wenzhou City, Zhejiang China
Data no
267690
Title
Executive Summary
Study date
January 2024
Auth party contact address
No. 555, Changan Road Yaoxi Subdistrict Wenzhou City, Zhejiang Wenzhou City, Zhejiang China
Date
Application Date
Application No
Application Number
142863
Product/Active constituent Name
Application Product Name
Powdered Deer Placenta
Application Date
Application Number
142863
Application Product Name
Powdered Deer Placenta
Application details
Product name:
Powdered Deer Placenta
Product number:
94584
Applicant Name:
NU-VET PTY LTD
Application purpose and description of use:
Registration of a sterile liquid product as an aid in maintaining joint mobility in dogs. In conjunction with approval of the active constituent, Powdered Deer Placenta, under 14A - an active for which there is only limited information.
Description of data provided:
Data no
267197
Title
Attachment 1 All details of API
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Date
Application Date
Application No
Application Number
142864
Product/Active constituent Name
Application Product Name
NU-EX-CELL
Application Date
Application Number
142864
Application Product Name
NU-EX-CELL
Application details
Product name:
NU-EX-CELL
Product number:
94585
Applicant Name:
NU-VET PTY LTD
Application purpose and description of use:
Registration of a sterile liquid product as an aid in maintaining joint mobility in dogs. In conjunction with approval of the active constituent, Powdered Deer Placenta, under 14A - an active for which there is only limited information.
Description of data provided:
Data no
283184
Title
Attachment 7: Analytical Methods & validations FP
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
283181
Title
Attachment 4: Batch Records
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
283178
Title
Chemistry & Manufacturing Mod 2.2
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
283179
Title
Attachment 2: CofA for excipients in FP & compendial monographs
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
283180
Title
Attachment 3: Manufacturing process FP
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
283182
Title
Attachment 5: Stability Justification
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
283183
Title
Attachment 6: Stability data FP
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
283185
Title
Attachment 8: Packaging details FP
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267157
Title
Efficacy and Safety Module 8 Clinical Efficacy an Overview
Study date
2024
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267158
Title
Full-thickness skin wound healing using human placenta-derived extracellular matrix containing bioactive molecules
Study date
2013
Auth party contact address
-
Data no
267159
Title
Human placental extract: a potential therapeutic in treating osteoarthritis.
Study date
2019
Auth party contact address
-
Data no
267161
Title
Can human placental extract help patients with osteoarthritis?
Study date
2018
Auth party contact address
-
Data no
267162
Title
Placenta Therapy: Its Biological Role of Anti-Inflammation and Regeneration
Study date
2018
Auth party contact address
-
Data no
267163
Title
Placental-Derived Biomaterials and Their Application to Wound Healing: A Review.
Study date
2023
Auth party contact address
-
Data no
267164
Title
Placental tissues as biomaterials in regenerative medicine.
Study date
2022
Auth party contact address
-
Data no
267165
Title
A novel approach for skin regeneration by a potent bioactive placental-loaded microneedle patch: comparative study of deer, goat, and porcine placentas.
Study date
2022
Auth party contact address
-
Data no
267166
Title
Scientific Evaluation of Nu-Ex-Cell Canine for Efficacy
Study date
2021
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267167
Title
Clinical Efficacy Part 2 Efficacy of Nu-Ex-Cell
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267168
Title
Attachment 1: Testimonial and clinical assessments
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267169
Title
Attachment 2: CofA BN2008H
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267170
Title
Clinical Efficacy Part 3 A Report on the Efficacy of Nu-Ex-Cell
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267171
Title
Attachment 1: Individual dog data sheets
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267173
Title
Attachment 3: CofA BN 803136
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267174
Title
Systematic Review of Outcome Measures Reported in Clinical Canine Osteoarthritis Research
Study date
2015
Auth party contact address
-
Data no
267175
Title
Clinical validity of outcome pain measures in naturally occurring canine osteoarthritis
Study date
2012
Auth party contact address
-
Data no
267176
Title
Outcome of Allogeneic Adult Stem Cell Therapy in Dogs Suffering from Osteoarthritis and Other Joint Defects
Study date
2018
Auth party contact address
-
Data no
267172
Title
Attachmint 2: Cooper Video. Note: File too large to upload. Available on requiest
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267160
Title
Anti-inflammatory and analgesic effects of human placenta extract.
Study date
2011
Auth party contact address
-
Data no
267177
Title
Efficacy & Safety: Safety Report
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267178
Title
Attachment 1Scientific Evaluation of Nu-Ex-Cell Canine for Safety
Study date
2021
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267179
Title
Attachment 2: Animal records - Haematology and blood chemistry
Study date
2021
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267180
Title
Attachment 3: Animal Records - Clinical veterinary check
Study date
2021
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267181
Title
Attachment 4: Statistical output - Haematology and blood chemistry
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267182
Title
Attachment 5: Statistical output - bodyweights and temperature
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267183
Title
Clinical pathology of Greyhounds and other sighthounds
Study date
2011
Auth party contact address
-
Data no
267155
Title
Pre-application Assistance - APVMA Written Assistance
Study date
2019
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267156
Title
Pre-application Assistance - APVMA Written Assistance
Study date
2020
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267187
Title
To the Director of APVMA
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267188
Title
Nu-Ex-Cell Intro
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267184
Title
Environmental Module 7.3
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267185
Title
Attachment 1: Details of the API
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Data no
267186
Title
Attachment 2: VICH Phase 1 assessment
Study date
2023
Auth party contact address
39 KILLARNEY AVENUE BLACKTOWN Australia
Date
Application Date
Application No
Application Number
143042
Product/Active constituent Name
Application Product Name
fluopyram
Application Date
Application Number
143042
Application Product Name
fluopyram
Application details
Product name:
fluopyram
Active name:
fluopyram
Applicant Name:
SINON AUSTRALIA PTY LIMITED
Application purpose and description of use:
Approval of fluopyram for use in agricultural chemical products.
Description of data provided:
Data no
267663
Title
Five Batch Analysis of fluopyram 98% Technical
Study date
8 September 2024
Auth party contact address
Level 7 60 York Street SYDNEY Australia
Data no
267666
Title
Amended Report to SNCL Report No VC03
Study date
5 February 2024
Auth party contact address
Level 7 60 York Street SYDNEY Australia
Data no
267664
Title
Manufacturing Process
Study date
January 2024
Auth party contact address
Level 7 60 York Street SYDNEY Australia
Data no
267665
Title
Declaration of Composition
Study date
22 January 2024
Auth party contact address
Level 7 60 York Street SYDNEY Australia
Data no
267662
Title
Part 2 Chemistry and Manufacture
Study date
February 2024
Auth party contact address
Level 7 60 York Street SYDNEY Australia
Date
Application Date
Application No
Application Number
142933
Product/Active constituent Name
Application Product Name
Goliath Plus Gel Bait
Application Date
Application Number
142933
Application Product Name
Goliath Plus Gel Bait
Application details
Product name:
Goliath Plus Gel Bait
Product number:
94607
Applicant Name:
BASF AUSTRALIA LTD.
Application purpose and description of use:
Registration of a 0.4 g/kg fipronil + 0.4 g/kg chlorfenapyr ready-to-use gel bait for the control of ants, cockroaches and silverfish in domestic, commercial, industrial and public buildings and facilities.
Reference details:
67325 - PHANTOM PRESSURISED INSECTICIDE
63575 - PHANTOM INSECTICIDE
49647 - GOLIATH GEL COCKROACH BAIT
70252 - GOLIATH LIQUID ANT BAIT
Active constituents:
Active constituent name
59286 - FIPRONIL
Active constituent name
52547 - FIPRONIL MANUFACTURING CONCENTRATE
Active constituent name
51985 - FIPRONIL
Active constituent name
49120 - FIPRONIL MANUFACTURING CONCENTRATE
Active constituent name
46789 - FIPRONIL
Active constituent name
86776 - Chlorfenapyr
Active constituent name
47986 - CHLORFENAPYR
Description of data provided:
Data no
267351
Title
2020/2107128 GLP Validation of Analytical Method AFR0171/01 and Certification of BAS 438 00 I
Study date
Feb 2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267349
Title
CoA Batch 2023-003A
Study date
Apr 2023
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267350
Title
2021/2001630 Determination of Oxidation/Reduction, Chemical incompatibility.
Study date
Feb 2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267348
Title
Summary Chemistry & Manufacture Goliath Plus
Study date
Feb 2024
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267353
Title
2021/2002324 Determination of physico-chemical properties according to UN Transport Regulation and Directive 94/37/EC
Study date
Apr 2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267354
Title
2021/2002325 Determination of the SADT according to UN Transport Regulation
Study date
Apr 2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267355
Title
2022/2023439 Estimation of Volatility by Thermogravimetry
Study date
May 2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267357
Title
2023/2055700 BAS 438 00 I Group A ??? Product Identity, Composition and Analysis
Study date
Nov 2023
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267352
Title
2021/2002327 Chemical Compatibility Test with HDPE
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267356
Title
2023/2052807 Determination of Physical/Chemical Properties of BAS 438 UB I: Accelerated Storage Stability and Corrosion Characteristics in Commercial Type Containers.
Study date
Jun 2023
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267370
Title
Summary Efficacy & Safety Goliath Plus
Study date
Feb 2024
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267371
Title
BAS19005 A laboratory efficacy study evaluating the knockdown and residual efficacy of the experimental cockroach bait BAS 438 00 I containing fipronil and chlorfenapyr against American and German cockroaches.
Study date
Apr 2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267372
Title
BAS20001 A laboratory efficacy study evaluating the knockdown and kill activity of the experimental gel bait BAS 438 00 I containing fipronil and chlorfenapyr against black house ants, white-footed house ants and coastal brown ants
Study date
Apr 2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267373
Title
BAS19007 A laboratory efficacy study evaluating the knockdown and residual efficacy of an experimental gel bait BAS 438 00 I containing fipronil and chlorfenapyr and GOLIATH?? GEL COCKROACH BAIT containing fipronil against silverfish.
Study date
Apr 2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267374
Title
A field efficacy study of BAS 438 00 I for the control of coastal brown ant and Greenhead ants.
Study date
Sep 2020
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267375
Title
Efficacy of BAS 438 HC I, a proposed global cockroach gel bait formulation, compared to leading competitor baits to German (Blattella germanica) and American (Periplaneta americana) cockroaches in a laboratory assay.
Study date
Jan 2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267376
Title
2052808 Comparison of insecticidal efficacy of cockroach gel baits, BAS 438 UB I to BAS 438 HC 1, against German cockroaches in a laboratory assay.
Study date
Nov 2023
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267377
Title
2052809 Comparison of insecticidal efficacy of cockroach gel baits, BAS 438 UB I to BAS 438 HC I, against American cockroaches in a laboratory assay
Study date
Nov 2023
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267367
Title
Volume 1 Preliminary Review Findings Report
Study date
Jun 2011
Auth party contact address
-
Data no
267368
Title
Pesticide Fact Sheet
Study date
Jan 2001
Auth party contact address
-
Data no
267369
Title
Pesticide Residues in Food 2018
Study date
Sep 2018
Auth party contact address
-
Data no
267347
Title
Permit to import conditionally non-prohibited goods
Study date
Jun 2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267366
Title
Summary Health Goliath Plus
Study date
Feb 2024
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267359
Title
2021/2004854 BAS 438 00 I Acute dermal toxicity study in rats.
Study date
June 2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267362
Title
2021/2009941 BAS 438 00 I Acute eye irritation in rabbits
Study date
June 2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267363
Title
2021/2007899 BAS 438 00 I In Vitro Eye Irritation Test (EIT) in Reconstructed Human Cornea
Study date
May 2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267360
Title
2021/2021757 BAS 438 00 I Technical trials to generate liquid aerosol atmosphere for a OECD-guideline-compliant acute inhalation toxicity study
Study date
June 2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267361
Title
2021/2023489 BAS 438 00 I: Waiver Request for Acute Inhalation Study
Study date
June 2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267358
Title
2021/2008657 BAS 438 00 I Acute oral toxicity study in rats.
Study date
June 2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267364
Title
2021/2009942 BAS 438 00 I Acute dermal irritation / corrosion in rabbits
Study date
June 2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
267365
Title
2021/2021717 BAS 438 00 I BUEHLER Test in guinea pigs
Study date
June 2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Date
Application Date
Application No
Application Number
143087
Product/Active constituent Name
Application Product Name
Oxfendoate-Oral Broad Spectrum Worm Paste for Horses
Application Date
Application Number
143087
Application Product Name
Oxfendoate-Oral Broad Spectrum Worm Paste for Horses
Application details
Product name:
Oxfendoate-Oral Broad Spectrum Worm Paste for Horses
Product number:
93028
Applicant Name:
RANDLAB AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration for Oxfendoate-Oral Broad Spectrum Worm Paste for Horses (93028), to vary the shelf life.
Active constituents:
Active constituent name
87945 - Oxfendazole
Active constituent name
87946 - Pyrantel embonate
Description of data provided:
Data no
267689
Title
Finished Product Specification
Study date
20/10/2023
Auth party contact address
71 Milperra Road Revesby Australia
Data no
267683
Title
Stability data
Study date
20/07/2023
Auth party contact address
71 Milperra Road Revesby Australia
Data no
267684
Title
Stability data
Study date
20/07/2023
Auth party contact address
71 Milperra Road Revesby Australia
Data no
267685
Title
Stability data
Study date
20/07/2023
Auth party contact address
71 Milperra Road Revesby Australia
Data no
267686
Title
Stability data
Study date
05/03/2024
Auth party contact address
71 Milperra Road Revesby Australia
Data no
267687
Title
Stability data
Study date
05/03/2024
Auth party contact address
71 Milperra Road Revesby Australia
Data no
267688
Title
Stability data
Study date
05/03/2024
Auth party contact address
71 Milperra Road Revesby Australia
Date
Application Date
Application No
Application Number
142645
Product/Active constituent Name
Application Product Name
Pyriproxyfen
Application Date
Application Number
142645
Application Product Name
Pyriproxyfen
Application details
Product name:
Pyriproxyfen
Active name:
Pyriproxyfen
Applicant Name:
India Pesticides Limited
Application purpose and description of use:
Approval of a new source of pyriproxyfen for use in agricultural chemical products
Description of data provided:
Data no
266203
Title
Study No.AG-G 2110 Study Title: FIVE BATCH ANALYSIS OF PYRIPROXYFEN TECHNICAL, Amendment 2
Study date
11/01/2024
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
266204
Title
Manufacturing Process for Pyriproxyfen Technical
Study date
19.1.2014
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
266205
Title
Raw Material Specification
Study date
19.1.2024
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
266206
Title
Item 17 application for approval of a new source of Pyriproxyfen
Study date
22.1.2024
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
266200
Title
Study No.AG-G 2110 Study Title: FIVE BATCH ANALYSIS OF PYRIPROXYFEN TECHNICAL,Volume 1
Study date
13/11/2023
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
266201
Title
Study No.AG-G 2110 Study Title: FIVE BATCH ANALYSIS OF PYRIPROXYFEN TECHNICAL, Volume 2
Study date
13/11/2023
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Data no
266202
Title
Study No.AG-G 2110 Study Title: FIVE BATCH ANALYSIS OF PYRIPROXYFEN TECHNICAL, Amendment 1
Study date
11/01/2024
Auth party contact address
WATER WORKS ROAD AlSHBAGH India
Date
Application Date
Application No
Application Number
142866
Product/Active constituent Name
Application Product Name
Moz-Q Extra Strength Insect Repellent
Application Date
Application Number
142866
Application Product Name
Moz-Q Extra Strength Insect Repellent
Application details
Product name:
Moz-Q Extra Strength Insect Repellent
Product number:
94587
Applicant Name:
Lifeguard Sciences (Pty) Ltd
Application purpose and description of use:
Registration of a 206g/L Picaridin/saltidin Pump spray used as a topical insect repellent that can provide up to 8hours protection against mosquitoes, house flies, biting midges, sand-flies, fleas and 4 hours against ticks. This product is suitable for children above 2years of age and the whole family.
Reference details:
82282 - REPEL NEW ERA PUMP SPRAY INSECT REPELLENT
Active constituents:
Active constituent name
44493 - PICARIDIN
Description of data provided:
Data no
280973
Title
Certificate of Analysis - Saltidin
Study date
29/05/2019
Auth party contact address
Saltigo, a member of Lanxess group
Data no
280974
Title
Certificate of Analysis - Saltidin
Study date
23/07/2024
Auth party contact address
Saltigo, a member of Lanxess group
Data no
267148
Title
Product Specification - Saltidin (Icaridin)
Study date
2014-09-12
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
267145
Title
Manufacturers Declaration
Study date
2024
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
267146
Title
Factory flow
Study date
2024
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
267154
Title
ANALYSIS OF MOZ-Q PUMP SPRAY : BATCH MozQ020219
Study date
2023-08-31
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
280970
Title
Product Moz-Q Xtra strength insect repellent spray
Study date
2024
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
280979
Title
MOZ-Q EXTRA STRENGTH INSECT REPELLENT (94587/142866)
Study date
19/11/2024
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
280980
Title
Certificate of Analysis
Study date
2024
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
280977
Title
Safety data sheet
Study date
02/11/2023
Auth party contact address
-
Data no
280978
Title
Safety data sheet
Study date
06/04/2021
Auth party contact address
-
Data no
280982
Title
Formulation_MOZ-Q EXTRA STRENGTH INSECT REPELLENT
Study date
20/11/2024
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
280983
Title
Safety data sheet
Study date
21/09/2020
Auth party contact address
-
Data no
282446
Title
SALTIGO Letter of Access
Study date
03/12/2024
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
280971
Title
Safety data sheet
Study date
15/03/2024
Auth party contact address
-
Data no
280975
Title
20% Clear Lotion and Pump-Spray Formulation
Study date
04/11/2009
Auth party contact address
Endura, Viale Pietramellara, 5 - 40121 Bologna (Italy)
Data no
280972
Title
Storage Stability
Study date
15/05/2006
Auth party contact address
Saltigo, a member of Lanxess group
Data no
267147
Title
Storage Stability
Study date
2024
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
280981
Title
RESPONSE TO SECTION 159 (1)(a) NOTICE: 94587/142866 MOZ-Q EXTRA STRENGTH INSECT REPELLENT_QUERY 7.
Study date
20/11/2024
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
282447
Title
RESPONSE TO SECTION 159 (1)(a) NOTICE: 94587/142866 MOZ-Q EXTRA STRENGTH INSECT REPELLENT 2025
Study date
08/01/2025
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
267149
Title
Letter of Access
Study date
2024-02-07
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
267144
Title
Declaration on Genetically Manipulated Organisms
Study date
24/10/2023
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
280976
Title
Moz-Q Extra Strength Insect Repellent (Decision ID: DC6-00009241)
Study date
23/07/2024
Auth party contact address
Saltigo, a member of Lanxess group
Data no
267150
Title
Certificate of Registration
Study date
2015-12-09
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
267151
Title
Certificate of Re-registration of pesticide
Study date
202-06-25
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
267153
Title
MOZ-Q EXTRA STRENGTH INSECT REPELLENT- SAFETY DATA SHEET
Study date
2024
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Data no
267152
Title
TOXICOLOGY REPORT FOR MOZ-Q EXTRA STRENGTH INSECT REPELLENT
Study date
2024
Auth party contact address
3 Pentrich Road Masons Mill Pietermaritzburg Kwa-Zulu Natal South Africa
Date
Application Date
Application No
Application Number
142925
Product/Active constituent Name
Application Product Name
GRANDEX BIOLOGICAL INSECTICIDE
Application Date
Application Number
142925
Application Product Name
GRANDEX BIOLOGICAL INSECTICIDE
Application details
Product name:
GRANDEX BIOLOGICAL INSECTICIDE
Product number:
69674
Applicant Name:
ANDERMATT GROUP AG
Application purpose and description of use:
Please refer to the written application (GRANDEX_Application Label Extension).
Active constituents:
Active constituent name
69687 - CYDIA POMONELLA GRANULOVIRUS STRAIN V22 (CPGV-V22)
Description of data provided:
Data no
267319
Title
EVALUATION OF ABC-V22 FOR THE CONTROL OF CODLING MOTH IN POME FRUIT
Study date
2012
Auth party contact address
STAHLERMATTEN 6 GROSSDIETWIL Switzerland
Data no
267320
Title
EVALUATION OF ABC-V22 FOR THE CONTROL OF CODLING MOTH IN POME FRUIT
Study date
2012
Auth party contact address
STAHLERMATTEN 6 GROSSDIETWIL Switzerland
Data no
267321
Title
EVALUATION OF ABC-V22 FOR THE CONTROL OF CODLING MOTH IN POME FRUIT
Study date
2012
Auth party contact address
STAHLERMATTEN 6 GROSSDIETWIL Switzerland
Data no
267322
Title
EVALUATION OF ABC-V22 FOR THE CONTROL OF ORIENTAL FRUIT MOTH IN STONE FRUIT
Study date
2011
Auth party contact address
STAHLERMATTEN 6 GROSSDIETWIL Switzerland
Data no
267323
Title
EVALUATION OF ABC-V22 FOR THE CONTROL OF ORIENTAL FRUIT MOTH IN STONE FRUIT
Study date
2012
Auth party contact address
STAHLERMATTEN 6 GROSSDIETWIL Switzerland
Data no
267324
Title
EVALUATION OF ABC-V22 FOR THE CONTROL OF ORIENTAL FRUIT MOTH IN STONE FRUIT
Study date
2012
Auth party contact address
STAHLERMATTEN 6 GROSSDIETWIL Switzerland
Data no
267325
Title
Efficacy evaluation of ABC-V22 and Lepinox Plus against Oriental Fruit Moth (Grapholita molesta) on nectarine
Study date
2011
Auth party contact address
STAHLERMATTEN 6 GROSSDIETWIL Switzerland
Data no
267326
Title
EVALUATE THE EFFICACY OF ABC-V22 AGAINST 1ST CODLING MOTH CYDIA POMONELLA (CM) GENERATION ON APPLE
Study date
2011
Auth party contact address
STAHLERMATTEN 6 GROSSDIETWIL Switzerland
Data no
267327
Title
OFFICIALY RECOGNIZED EFFICACY TRIAL WITH AGB 036 AGAINST CYDIA POMONELLA ON PEAR CV CONFERENCE IN OPEN FIELD
Study date
2011
Auth party contact address
STAHLERMATTEN 6 GROSSDIETWIL Switzerland
Data no
267328
Title
The efficacy of ABC- V22 against Cydia molesta on peach
Study date
2011
Auth party contact address
STAHLERMATTEN 6 GROSSDIETWIL Switzerland
Data no
267329
Title
Efficacy evaluation of ABC-V22 against Codling moth (Cydia pomonella L.) and Oriental fruit moth (Grapholita molesta B.) on pear
Study date
2011
Auth party contact address
STAHLERMATTEN 6 GROSSDIETWIL Switzerland
Data no
267316
Title
Label extension
Study date
2024
Auth party contact address
STAHLERMATTEN 6 GROSSDIETWIL Switzerland
Data no
267317
Title
Product label
Study date
2024
Auth party contact address
STAHLERMATTEN 6 GROSSDIETWIL Switzerland
Data no
267318
Title
Draft label
Study date
2024
Auth party contact address
STAHLERMATTEN 6 GROSSDIETWIL Switzerland
Date
Application Date
Application No
Application Number
143038
Product/Active constituent Name
Application Product Name
PORCILIS PCV IDAL EMULSION FOR INJECTION FOR PIGS
Application Date
Application Number
143038
Application Product Name
PORCILIS PCV IDAL EMULSION FOR INJECTION FOR PIGS
Application details
Product name:
PORCILIS PCV IDAL EMULSION FOR INJECTION FOR PIGS
Product number:
84901
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of label approval to update claims section to extend the duration of immunity.
Active constituents:
Active constituent name
83163 - PORCINE CIRCOVIRUS TYPE 2 ORF2 SUBUNIT ANTIGEN
Description of data provided:
Data no
276770
Title
SOP qPCR PCV
Study date
13/04/2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276776
Title
BP Lawsonia ID
Study date
15/06/2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276777
Title
BP PCV M Hyo ID Once
Study date
2018
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276778
Title
BP PRRS
Study date
2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
267627
Title
Batch record A025A01
Study date
March 2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
267628
Title
Efficacy report
Study date
2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
267626
Title
Report 086063 Efficacy of vaccine against challenge
Study date
28 Jan 2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276780
Title
Efficacy OOI Associate Use
Study date
26/10/2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276771
Title
Report 070736 Efficacy OOI associated use
Study date
1/09/2020
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276772
Title
Report 107171 Efficacy DOI associated use
Study date
04/04/2022
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276773
Title
Report 076365 Onset of immunity
Study date
13/10/2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276774
Title
Report 076359 Duration of Immunity
Study date
29/10/2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276775
Title
Report 081829 Efficacy OOI Associate Use
Study date
05/11/2021
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276779
Title
EMA report
Study date
05/10/2023
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Date
Application Date
Application No
Application Number
142735
Product/Active constituent Name
Application Product Name
Haloxyfop-p-methyl
Application Date
Application Number
142735
Application Product Name
Haloxyfop-p-methyl
Application details
Product name:
Haloxyfop-p-methyl
Active name:
Haloxyfop-p-methyl
Applicant Name:
NACL Industries Limited
Application purpose and description of use:
Approval of Haloxyfop-p-methyl for use in agricultural chemical products.
Description of data provided:
Data no
266756
Title
Five Batch Analysis of Haloxyfop-p-Methyl Technical.
Study date
4 January 2024
Auth party contact address
Plot No. 12-A, "C" Block Lakshmi Towers, Nagarjuna Hills Panjagutta, Hyderabad Telangana India
Data no
279356
Title
Active Ingredient content & Dimethyl Sulfate Content of Haloxydop-R-Methyl Technical
Study date
October 2024
Auth party contact address
Plot No. 12-A, "C" Block Lakshmi Towers, Nagarjuna Hills Panjagutta, Hyderabad Telangana India
Data no
266753
Title
Manufacturing Process and Impurity Information of Haloxyfop-(p)-Methyl Technical.
Study date
January 2024
Auth party contact address
Plot No. 12-A, "C" Block Lakshmi Towers, Nagarjuna Hills Panjagutta, Hyderabad Telangana India
Data no
266754
Title
Quality Control Method of Haloxyfop-(p)-Methyl Technical
Study date
January 2024
Auth party contact address
Plot No. 12-A, "C" Block Lakshmi Towers, Nagarjuna Hills Panjagutta, Hyderabad Telangana India
Data no
266755
Title
Declaration of Composition
Study date
9 January 2024
Auth party contact address
Plot No. 12-A, "C" Block Lakshmi Towers, Nagarjuna Hills Panjagutta, Hyderabad Telangana India
Data no
266757
Title
Haloxyfop-p-Methyl Technical.
Study date
30 January 2024
Auth party contact address
Plot No. 12-A, "C" Block Lakshmi Towers, Nagarjuna Hills Panjagutta, Hyderabad Telangana India
Data no
279357
Title
Sub: Notice of Agricultural and Veterinary Chemicals Code (1994). Section 159(1)(a) - Notice of Information or Sample. Ref: Application number 142735; Active Constituent Name: Haloxyfop-p-methyl
Study date
15 October 2024
Auth party contact address
Plot No. 12-A, "C" Block Lakshmi Towers, Nagarjuna Hills Panjagutta, Hyderabad Telangana India
Data no
266752
Title
Executive Summary
Study date
January 2023
Auth party contact address
Plot No. 12-A, "C" Block Lakshmi Towers, Nagarjuna Hills Panjagutta, Hyderabad Telangana India
Date
Application Date
Application No
Application Number
142951
Product/Active constituent Name
Application Product Name
copper pyrithione
Application Date
Application Number
142951
Application Product Name
copper pyrithione
Application details
Product name:
copper pyrithione
Active name:
copper pyrithione
Applicant Name:
KOLON LIFE SCIENCE, INC
Application purpose and description of use:
Approval of copper pyrithione for use in agricultural chemical products.
Description of data provided:
Data no
267470
Title
Method Validation Report on Determination of Copper Pyrithione in Technical Grade "CleanBio???Cu???/"CleanBio-CY???. Study No. NCN19050085C01-2
Study date
8 March 2020
Auth party contact address
Kolon One & Only Tower 110, Magokdong-ro Gangseo-gu, Seoul Korea, South
Data no
267469
Title
5 Batch Study of Copper Pyrithione Content in Technical Grade of Cleanbio-Cu/Cleanbio-Cy. Study No. GLP/20/003.
Study date
7 April 2020.
Auth party contact address
Kolon One & Only Tower 110, Magokdong-ro Gangseo-gu, Seoul Korea, South
Data no
267471
Title
Quality Control of CPT.
Study date
2 February 2024
Auth party contact address
Kolon One & Only Tower 110, Magokdong-ro Gangseo-gu, Seoul Korea, South
Data no
267472
Title
Copper pyrithione chemistry dossier ID DC17-67919682.
Study date
19 February 2024.
Auth party contact address
Kolon One & Only Tower 110, Magokdong-ro Gangseo-gu, Seoul Korea, South
Data no
278193
Title
Five Batch Characterisation of Structure of Copper Pyrithione by IR
Study date
AUGUST 2024
Auth party contact address
Kolon One & Only Tower 110, Magokdong-ro Gangseo-gu, Seoul Korea, South
Data no
278194
Title
Five Batch Characterisation of Structure of Copper Pyrithione by Mass, UV
Study date
AUGUST 2024
Auth party contact address
Kolon One & Only Tower 110, Magokdong-ro Gangseo-gu, Seoul Korea, South
Data no
278195
Title
Description of the manufacturing process ? Copper pyrithione
Study date
September 2024
Auth party contact address
Kolon One & Only Tower 110, Magokdong-ro Gangseo-gu, Seoul Korea, South
Data no
278196
Title
Five Batch Impurity Analysis of Copper Pyrithione by HPLC
Study date
August 2024
Auth party contact address
Kolon One & Only Tower 110, Magokdong-ro Gangseo-gu, Seoul Korea, South
Data no
278197
Title
Declaration of Composition
Study date
12 September 2024
Auth party contact address
Kolon One & Only Tower 110, Magokdong-ro Gangseo-gu, Seoul Korea, South
Data no
267468
Title
Technical Note Identification Data (IR, HPLC) of Copper pyrithione technical. .
Study date
September 3 2019
Auth party contact address
Kolon One & Only Tower 110, Magokdong-ro Gangseo-gu, Seoul Korea, South
Data no
278192
Title
Response to s.159 notice: 18 July 2024
Study date
13 September 2024
Auth party contact address
Kolon One & Only Tower 110, Magokdong-ro Gangseo-gu, Seoul Korea, South
Date
Application Date
Application No
Application Number
142648
Product/Active constituent Name
Application Product Name
Dinotefuran
Application Date
Application Number
142648
Application Product Name
Dinotefuran
Application details
Product name:
Dinotefuran
Active name:
Dinotefuran
Applicant Name:
HAILIR PESTICIDES AND CHEMICALS GROUP CO., LTD
Application purpose and description of use:
Approval of dinotefuran for use in agricultural chemical products.
Description of data provided:
Data no
266211
Title
5 Batch Analysis of Dinotefuran Technical
Study date
20-01-2022
Auth party contact address
East Industry Zone Chengyang District Qingdao China
Data no
266212
Title
The Synthesis and Impurities Description of Dinotefuran Technical
Study date
Jan 2024
Auth party contact address
East Industry Zone Chengyang District Qingdao China
Data no
266209
Title
SDSs
Study date
Jan 2024
Auth party contact address
East Industry Zone Chengyang District Qingdao China
Data no
266210
Title
DOC
Study date
Jan 2024
Auth party contact address
East Industry Zone Chengyang District Qingdao China
Date
Application Date
Application No
Application Number
142566
Product/Active constituent Name
Application Product Name
Salmonella Enteritidis PT4
Application Date
Application Number
142566
Application Product Name
Salmonella Enteritidis PT4
Application details
Product name:
Salmonella Enteritidis PT4
Product number:
94482
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a trivalent Salmonella vaccine for injection for chickens.
Approval of three salmonella active constituents.
Description of data provided:
Data no
267538
Title
Validation of salmonella enteritidis inactivation control
Study date
12 Nov 2002
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267542
Title
SE IRP test validation
Study date
28 November 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267546
Title
Standard Operating Procedure: GRA-TI-QC-204
Study date
January 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267547
Title
Confirmation of Identity of Salmonella enteritidis
Study date
8 November 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267548
Title
Gel electrophoresis of iron restricted proteins in Salmonella antigens
Study date
January 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267540
Title
SE assay validation
Study date
28 February 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267558
Title
Antigenic formulae of the Salmonella serovars
Study date
2007
Data no
267541
Title
SE Ag mass
Study date
15 November 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267555
Title
SE Masterseed test results
Study date
13 August 1998
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267556
Title
SE Working seed CoA
Study date
6 October 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267557
Title
SE stability data
Study date
December 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267550
Title
Ag. summary protocol SE Batch LSE10180
Study date
22 March 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267551
Title
Ag. summary protocol SE Batch LSE10181
Study date
20 April 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267552
Title
Ag. summary protocol SE Batch LSE10182
Study date
20 April 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267553
Title
Ag. summary protocol SE Batch LSE10187
Study date
22 March 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267554
Title
SE PT4 strain history and production
Study date
24 March 1999
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267549
Title
Preparation of working and production seeds
Study date
21 March 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267543
Title
3000L Inactivation Kinetics
Study date
December 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267544
Title
Antigen transfer validation
Study date
May 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267545
Title
Antigen transfer to manufacture site
Study date
1 May 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267539
Title
SE inactivation batch test results
Study date
December 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267536
Title
Inactivation kinetics of salmonella entertidis
Study date
September 1994
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267537
Title
Inactivation kinetics for salmonella enteritidis
Study date
10 June 1997
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
142567
Product/Active constituent Name
Application Product Name
Nobilis Salenvac ETC Suspension for Injection for Chickens
Application Date
Application Number
142567
Application Product Name
Nobilis Salenvac ETC Suspension for Injection for Chickens
Application details
Product name:
Nobilis Salenvac ETC Suspension for Injection for Chickens
Product number:
94483
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a trivalent Salmonella vaccine for injection for chickens.
Approval of three salmonella active constituents.
Active constituents:
Active constituent name
94482 - Salmonella Enteritidis PT4
Active constituent name
94484 - Salmonella Typhimurium strain DT104
Active constituent name
94485 - Salmonella Infantis strain S03499-06
Description of data provided:
Data no
282490
Title
ST assay validation
Study date
28 February 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
282491
Title
Standard Operating Procedure: GRA-TI-QC-206
Study date
January 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
282487
Title
Confirmation of salmonella typhimurium inactivation
Study date
5 September 2002
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
282488
Title
Validation of salmonella typhimurium inactivation control
Study date
19 September 2002
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
282492
Title
Ag. summary protocol ST Batch LSTE0007
Study date
26 January 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
282493
Title
Ag. summary protocol ST Batch LSTS0190
Study date
26 January 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
282494
Title
Ag. summary protocol ST Batch LSTS0191
Study date
26 January 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
282495
Title
Ag. summary protocol ST Batch LSTS0192
Study date
26 January 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
282497
Title
ST Master seed test results
Study date
30 October 1996
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
282498
Title
ST working seed CoA
Study date
17 January 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
282496
Title
ST seed history and production
Study date
16 December 1999
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
282485
Title
Inactivation kinetics for salmonella typhimurium
Study date
16 December 1997
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
282486
Title
Salmonella typhimurium inactivation on a production scale
Study date
16 April 2002
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
282489
Title
ST inactivation batch test results
Study date
December 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265357
Title
Methods of Endotoxin Removal from Biological Preparations: a Review
Study date
2007
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265157
Title
Validation of excipient determination
Study date
7 June 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265158
Title
SI controls SDS-PAGE
Study date
4 November 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265159
Title
Transfer and Val of excipient test
Study date
21 January 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265160
Title
QA379R-19 - Transfer and co-validation- Excipient test
Study date
17 January 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265161
Title
KRE-TRA-R - Excipient method transfer-val
Study date
April 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265162
Title
KRE-TRA-Excipient method transfer-val
Study date
April 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265210
Title
Validation of the Salenvac TC Potency Test - Enteritidis, Typhimurium and Infantis Serovars
Study date
20 June 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265207
Title
Interim precision data for Salenvac TC Testing
Study date
8 July 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265165
Title
KRE-TRA-R-IRP Establish SI_SE_ST release tests
Study date
January 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265166
Title
Report KRE-VAL R-Inactivation test ST and SE
Study date
January 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265167
Title
Report KRE-VAL R-Inactivation test ST and SE
Study date
January 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265168
Title
KRE-TRA-R Ag. mass ELISA method transfer
Study date
January 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265169
Title
KRE-TRA-R Ag. mass ELISA ST method tfer
Study date
January 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265170
Title
KRE-TRA-R Ag. mass ELISA SI method tfer
Study date
January 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265171
Title
KRE-TRA-R Excipient test method transfer
Study date
January 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265176
Title
Method for he Potency Testing of Salenvac ETC
Study date
29 November 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265177
Title
Standard Operating Procedure: KRE-TPR-RA-201
Study date
12 April 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265178
Title
Method for the Potency Testing of Salenvac ETC
Study date
29 November 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265179
Title
Standard Operating Procedure: KRE-TPR-RA-202[
Study date
April 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265180
Title
Method for the Potency Testing of Salenvac ETC
Study date
29 November 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265181
Title
Standard Operating Procedure: KRE-TPR-RA-203
Study date
April 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265182
Title
The Preparation of a Gram Stain
Study date
16 June 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265183
Title
Testing Bacterial Colony Smoothness
Study date
30 January 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265185
Title
Confirmation of the identity of Salmonella dublin and Salmonella typhimurium
Study date
3 July 2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265187
Title
Procedure for the description of colony morphology of bacteria
Study date
4 May 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265189
Title
Determination of pH in antigen
Study date
26 June 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265190
Title
Determination of thiomersal for salvenac vaccine
Study date
12 April 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265191
Title
Determination of Thiomersal Content in the Salenvac vaccine
Study date
April 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265192
Title
Sterility testing
Study date
29 January 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265193
Title
Sterility Test
Study date
February 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265194
Title
Sterility test on biological and pharmaceutical products
Study date
27 October 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265195
Title
Inactivation control of antigens and vaccines
Study date
January 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265196
Title
Determination of pH, volume and appearance of filled containers
Study date
19 July 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265197
Title
Determination of volume and appearance of parenteral preparations
Study date
April 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265198
Title
Determination of pH in parenteral preparations
Study date
April 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265199
Title
pH measurement of vaccines
Study date
3 November 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265200
Title
Determination of excipient for Salenvac Vaccine
Study date
18 March 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265201
Title
Determination of excipient content in Salenvac vaccine
Study date
April 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265202
Title
Determination of excipient
Study date
January 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265203
Title
Determination of Aluminium
Study date
23 February 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265204
Title
Determination of Aluminum Content in vaccines and raw materials
Study date
April 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265259
Title
Batch protocol E016ZA
Study date
27 September 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265154
Title
PE testing 079A 080A
Study date
15 October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265214
Title
Potency data
Study date
4 May 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265215
Title
Batch protocol EST1ZA
Study date
31 May 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265216
Title
Batch protocol EST2ZA
Study date
30 June 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265217
Title
Batch protocol EST3ZA
Study date
31 July 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265218
Title
Batch protocol EXSEC27
Study date
31 August 2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265219
Title
Batch protocol EXSEC29
Study date
31 August 2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265220
Title
Batch protocol EXSEC30
Study date
30 June 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265221
Title
Batch protocol EXSEC39
Study date
30 November 2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265222
Title
Batch protocol EXSEC40
Study date
30 June 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265223
Title
Batch protocol EXSEC56
Study date
31 May 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265224
Title
Batch protocol EXSEC65
Study date
30 April 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265225
Title
Batch protocol EXSEC71
Study date
8 December 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265226
Title
Batch protocol EXSEC72
Study date
8 December 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265227
Title
Batch protocol EXSEC73
Study date
8 December 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265228
Title
Batch protocol EXSEC74
Study date
14 December 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265229
Title
Batch protocol EXSEC75
Study date
14 December 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265230
Title
Batch protocol EXSEC77
Study date
31 May 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265231
Title
Batch protocol EXSEC79A
Study date
March 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265232
Title
Batch protocol EXSEC80A
Study date
January 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265233
Title
Batch protocol EXSEC95
Study date
January 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265234
Title
Manuf. Batch Protocol Salenvac ETC
Study date
May 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265235
Title
Batch protocol EXSEC100
Study date
4 July 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265236
Title
Batch protocol EXSEC101
Study date
4 July 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265237
Title
Batch protocol EXSEC102
Study date
4 July 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265238
Title
Batch protocol 001EZA
Study date
29 March 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265239
Title
Batch protocol 003EZA
Study date
22 February 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265240
Title
Batch protocol 007EZA
Study date
22 February 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265241
Title
Batch protocol VM210509.1
Study date
24 April 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265242
Title
Batch protocol VM210509.2
Study date
24 April 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265243
Title
Batch protocol VM210509.3
Study date
24 April 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265208
Title
Discrimination between standard, minimum potency and sub-standard batches of vaccine in the Salenvac TC potency test
Study date
8 July 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265209
Title
Substandard batches of Salenvac TC in the Salenvac TC Potency Test
Study date
18 August 2015
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265211
Title
Discrimination between standard, minimum, sub-potent batches of vaccine and upper safety limit setting in the Salenvac TC potency test
Study date
2 October 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265212
Title
Validation of replacement batches of minimum potency reference vaccine for the Salenvac ETC potency assay
Study date
28 November 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265213
Title
Summary Report for the Correlation Between Cell Count and Antigen Mass Values for the Reference Vaccine Batches of Salenvac ETC Potency Assay
Study date
31 January 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265328
Title
Statement- change in supplier eggs
Study date
6 February 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285227
Title
CoA Dipyridyl
Study date
June 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285228
Title
Nobilis Salenvac batch protocol BN EXSEC097
Study date
July 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285229
Title
Nobilis Salenvac batch protocol BN EXSEC098
Study date
July 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285230
Title
Nobilis Salenvac batch protocol BN EXSEC099
Study date
July 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285231
Title
Report KRE-TRA_R-Potency_ELISA_Salmonella_ Enteritidis
Method transfer summary report- Potency ELISA Salmonella enteritidiis for Salenvac ETC.
Method transfer summary report- Potency ELISA Salmonella enteritidiis for Salenvac ETC.
Study date
March 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285232
Title
Report KRE- RA_R-Potency_ELISA_Salmonella_Typhimurium
Method transfer summary report- Potency ELISA Salmonella typhimurium for Salenvac ETC
Method transfer summary report- Potency ELISA Salmonella typhimurium for Salenvac ETC
Study date
March 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285233
Title
Report KRE-TRA_R-Potency_ELISA_Salmonella_Infantis
Method transfer summary report- Potency ELISA Salmonella infantis for Salenvac ETC
Method transfer summary report- Potency ELISA Salmonella infantis for Salenvac ETC
Study date
March 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285235
Title
Statistical analysis report for potency test of S. Typhimurium
[Statistical analysis of the method transfer of the potency ELISA for Salmonela typhimurium in Salenvac ETC from QC MK to QC K
[Statistical analysis of the method transfer of the potency ELISA for Salmonela typhimurium in Salenvac ETC from QC MK to QC K
Study date
March 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285236
Title
Statistical analysis of the method transfer of the potency ELISA for Salmonela infantis in Salenvac ETC from QC MK to K
Study date
February 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285237
Title
Method transfer and co-validation report - Determination of aluminium for Salenvac ETC
Study date
March 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265254
Title
Batch protocol 3S002A
Study date
20 December 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265255
Title
Batch protocol 3S003A
Study date
25 October 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265256
Title
Batch protocol 3S005A
Study date
25 October 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265257
Title
Batch protocol E014ZA
Study date
27 September 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265258
Title
Batch protocol E015ZA
Study date
27 September 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265115
Title
Sites of manufacture
Study date
May 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265172
Title
detailed transfer report
Study date
7 December 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265103
Title
S0834-2 Part 2 Dossier
Study date
January 2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265108
Title
GMP1
Study date
7 June 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265109
Title
GMP2
Study date
June 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265110
Title
GMP3
Study date
16 February 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265111
Title
GMP4
Study date
23 July 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265112
Title
GMP4.1 GMP Guidance
Study date
7 December 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265113
Title
GMP5
Study date
4 March 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265117
Title
DACS on Quality
Study date
11 March 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265118
Title
Additional DACS on Quality
Study date
1 May 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265119
Title
Additional DACS on Quality - Shelf Life
Study date
20 June 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265120
Title
Additional DACS on Quality
Study date
May 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265121
Title
Additionals DACS on Quality
Study date
20 November 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265124
Title
Manufacture and Validations
Study date
March 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265125
Title
Inactivation kinetics
Study date
March 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265127
Title
Fermenter media buffer
Study date
May 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265128
Title
Vaccine base preparation
Study date
March 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265269
Title
Product CoA
Study date
12 July 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265270
Title
Excipient CoA
Study date
December 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265271
Title
Excipient CoA
Study date
26 April 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265272
Title
Excipient CoA
Study date
6 December 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265273
Title
Excipient CoA
Study date
21 June 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265274
Title
Excipient CoA
Study date
23 February 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265275
Title
Excipient CoA
Study date
26 June 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265276
Title
Excipient CoA
Study date
1 November 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265277
Title
Thiomersal CoA
Study date
2 June 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265278
Title
Excipient CoA
Study date
7 November 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265279
Title
Excipient CoA
Study date
7 November 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265280
Title
Excipient CoA
Study date
21 April 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265281
Title
Excipient CoA
Study date
19 August 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265282
Title
Excipient CoA
Study date
September 2020
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265283
Title
Excipient CoA
Study date
16 November 2006
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265284
Title
Excipient CoA
Study date
2 June 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265285
Title
Excipient CoA
Study date
25 September 2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265286
Title
Excipient CoA
Study date
4 October 2010
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265206
Title
Method for the replacement of Salenvac ETC
Study date
18 February 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265114
Title
GMP6
Study date
25 March 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265130
Title
CoA bottles
Study date
8 July 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265131
Title
Drawings Bottles
Study date
December 2008
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265132
Title
Irradiation Bottles
Study date
18 January 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265133
Title
Stopper and seal Quality Certificate
Study date
12 December 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285225
Title
CoA Combi Seals
Study date
Aug 2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285226
Title
D-rawing- Combi seals
Study date
January 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265163
Title
QA848A-22 PE testing beyond shelf life
Study date
21 October 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285238
Title
KRE-TRA_R-FPU_Salenvac ETC_Stability_Report
Study date
August 2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265153
Title
PE testing start of SL
Study date
24 January 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265155
Title
PE testing middle SL
Study date
15 October 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265156
Title
QA338-18R method suitability-sterility
Study date
24 January 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265129
Title
Stability Tests
Study date
June 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265104
Title
S0834-2 Part 8 Dossier
Study date
December 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265288
Title
EU Part 4- Efficacy trials
Study date
November 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265289
Title
Discussion on efficacy per EP monographs
Study date
March 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265296
Title
Optimisation of Salmonella Group C Challenge in Conventional Layers
Study date
23 May 2011
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265297
Title
Testing of new Salmonella Infantis challenge strains in Conventional Layers
Study date
6 September 2011
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265298
Title
Challenge Model Optimisation of Salmonella Infantis in Layer Chickens at 14 Weeks of Age
Study date
24 June 2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265299
Title
Investigating the Dynamics of S. Infantis Challenge in Layers at 10 Weeks of Age
Study date
15 November 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265300
Title
Evaluation of a Salmonella Infantis Challenge in Mature Layer Chickens
Study date
12 May 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265301
Title
Development of Salmonella Heidelberg Challenge Model
Study date
8 February 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265302
Title
Optimisation of a Salmonella Hadar Challenge Model in 10 Week Old Layers
Study date
7 February 2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265303
Title
Strain Selection for a Salmonella Virchow Challenge Model in Layer Chickens.
Study date
23 February 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265304
Title
OPTIMISATION OF A Salmonella ENTERITIDIS CHALLENGE MODEL IN 10 WEEK OLD LAYERS
Study date
18 May 2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265305
Title
Optimisation of a Salmonella Typhimurium Challenge Model in 13 Week Old Layers
Study date
4 March 2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265306
Title
Serological Response of Chickens to Salenvac ETC Following Different Vaccination Schedules.
Study date
11 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265307
Title
Efficacy Testing of Salenvac TC against a Salmonella Enteritidis Challenge in Layer Chickens at 14 Weeks of Age.
Study date
13 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265308
Title
Efficacy Testing of a Salenvac TC against Salmonella Enteritidis Challenge in Layer Chickens at 14 Weeks of Age
Study date
13 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265309
Title
Efficacy Testing of Salenvac TC against a Salmonella Enteritidis Challenge in Layer Chickens at 14 Weeks of Age
Study date
13 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265310
Title
Efficacy Testing of Salenvac TC against a Salmonella Typhimurium Challenge in Layer Chickens at 14 Weeks of Age
Study date
13 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265311
Title
Efficacy Testing of Salenvac TC against a Salmonella Typhimurium Challenge in Layer Chickens at 14 Weeks of Age
Study date
13 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265312
Title
Efficacy Testing of Salenvac TC against a Salmonella lnfantis Challenge in Layer Chickens at 14 Weeks of Age
Study date
13 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265313
Title
Efficacy Testing of Salenvac TC against a Salmonella Infantis Challenge in Layer Chickens at 14 Weeks of Age
Study date
13 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265314
Title
Documentation of Elisa results for serum samples
Study date
30 November 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265315
Title
Duration of Immunity - Testing of Salenvac TC against a Salmonella Enteritidis challenge in layer chickens between 55 and 65 weeks of age.
Study date
13 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265316
Title
Duration of Immunity - Testing of Salenvac TC Against a Salmonella Enteritidis Challenge in Layer Chickens Between 55 and 75 Weeks of Age.
Study date
13 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265317
Title
Duration of Immunity - Testing of Salenvac TC Against a Salmonella Enteritidis Challenge in Layer Chickens Between 80 and 90 Weeks of Age.
Study date
13 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265318
Title
Duration of Immunity - Testing of Salenvac TC Against a Salmonella Typhimurium Challenge in Layer Chickens Between 55 and 65 Weeks of Age.
Study date
13 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265319
Title
Duration of Immunity- Testing of Salenvac TC Against a Salmonella Typhimurium Challenge in Layer Chickens Between 55 and 75 Weeks of Age.
Study date
13 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265320
Title
Duration of Immunity - Testing of Salenvac TC Against a Salmonella Infantis Challenge in Layer Chickens Between 55 and 65 Weeks of Age.
Study date
13 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265321
Title
Efficacy Testing of Salenvac TC against a Salmonella Hadar Challenge in Layer Chickens at 14 Weeks of Age.
Study date
13 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265322
Title
Duration of immunity - testing of Salenvac TC against a Salmonella hadar challenge in layer chickens between 80 and 90 weeks of age
Study date
13 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265323
Title
Duration of Immunity - Testing of Salenvac TC against a Salmonella Hadar challenge in layer chickens between 55 and 65 weeks of age.
Study date
13 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265324
Title
Efficacy Testing of Salenvac TC against Salmonella Heidelberg Challenge in Layer Chickens at 14 Weeks of Age
Study date
13 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265325
Title
Efficacy Testing of Salenvac TC against Sfllmonella Virchow Challenge in Layer Chickens at 14 Weeks of Age
Study date
13 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265326
Title
Duration of immunity of Salenvac TC in Layer Chickens
Study date
29 March 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265327
Title
Report Meta-Analysis efficacy studies
Study date
29 March 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285239
Title
European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2016. One Health 2022 Zoonoses Report, Nov 2017.
Study date
November 2017
Auth party contact address
-
Data no
285240
Title
Characterisation and whole genome sequencing of closely related multidrug- resistant Salmonella enterica serovar Heidelberg isolates from imported poultry meat in the Netherlands [Plos ONE 14(7): e0219795]
Study date
July 2019
Auth party contact address
-
Data no
285241
Title
The European Union One Health 2022 Zoonoses Report, November 2023
Study date
November 2023
Auth party contact address
-
Data no
285242
Title
NL/V/0305/001/DC Publically available assessment report. Sept 2020
Study date
September 2020
Auth party contact address
-
Data no
285243
Title
SOP.GLM.4002C
(Chicken) antibody response to Salmonella flagella antigens using ELISA
(Chicken) antibody response to Salmonella flagella antigens using ELISA
Study date
January 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285244
Title
SOP.GLM.4003B
(Chicken) antibody response to Salmonella LPS antigens using ELISA.
(Chicken) antibody response to Salmonella LPS antigens using ELISA.
Study date
May 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285245
Title
Field study STP/0073/05
Passive immunity to salmonella enteritidis infection in progeny of Salenvac T vaccinated birds
Passive immunity to salmonella enteritidis infection in progeny of Salenvac T vaccinated birds
Study date
May 2008
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285246
Title
Field study STP/0083/05
Passive immunity to salmonella typhimurium infection in progeny of Salenvac T vaccinated birds
Passive immunity to salmonella typhimurium infection in progeny of Salenvac T vaccinated birds
Study date
May 2008
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285247
Title
Field study STP/0058/07
Investigation of Maternal Antibody levels in progeny of Salenvac T vaccinated flocks at various ages during lay
Investigation of Maternal Antibody levels in progeny of Salenvac T vaccinated flocks at various ages during lay
Study date
March 2010
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285248
Title
Field study STP/0026/10
A comparison of antibody levels in commercial chicks from Salenvac T vaccinated flocks to those of chicks shown to be protected against Salmonella colonisation
A comparison of antibody levels in commercial chicks from Salenvac T vaccinated flocks to those of chicks shown to be protected against Salmonella colonisation
Study date
January 2010
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265123
Title
DACS on Efficacy Tests
Study date
11 March 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265330
Title
Field efficacy in broiler breeders of Salenvac TC against Salmonella Enteritidis challenge
Study date
12 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265331
Title
Field efficacy in broiler breeders of Salenvac TC against Salmonella Typhimurium challenge
Study date
12 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265332
Title
Field efficacy in broiler breeders of Salenvac TC against Salmonella Infantis challenge
Study date
12 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265333
Title
Field efficacy in broiler breeders of Salenvac TC against Salmonella Hadar challenge
Study date
12 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265334
Title
Efficacy and Safety field trial in pullets
Study date
1 March 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265335
Title
Estimation of the impact of vaccination on faecal shedding and organ and egg contamination for Salmonella Enteritidis, Salmonella Typhiumurium and monophasic Salmonella Typhimurium
Study date
2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265336
Title
Salmonella enteritidis clearance and immune responses in chickens following Salmonella vaccination and challenge
Study date
2004
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265337
Title
Immunisation of laying hens against Salmonella enteritidis with live attenuated vaccines
Study date
1990
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265338
Title
The paratyphoid salmonellae
Study date
2000
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265339
Title
Salmonella infections: immune and non-immune protection with vaccines
Study date
2007
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265341
Title
Chicken Cecum Immune Response to Salmonella enterica Serovars of Different Levels of Invasiveness
Study date
1966
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265342
Title
Passive Immunization with Antibodies against Iron-Regulated Outer Membrane Proteins Protects Turkeys from Escherichia coli Septicemia
Study date
1987
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265345
Title
Efficacy of a Novel Trivalent Inactivated Vaccine against the Shedding of Salmonella in a Chicken Challenge Model
Study date
2009
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265348
Title
Humoral and cellular immune response generated by different vaccine programs before and after Salmonella Enteritidis challenge in chickens
Study date
2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265352
Title
Live and inactivated vaccine regimens against caecal Salmonella Typhimurium colonisation in laying hens
Study date
2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265353
Title
Development and Evaluation of an Experimental Vaccination Program Using a Live Avirulent Salmonella typhimurium Strain To Protect Immunized Chickens against Challenge with Homologous and Heterologous Salmonella Serotypes
Study date
1994
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265358
Title
Chicken innate immune response to oral infection with Salmonella enterica serovar Enteritidis
Study date
2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265359
Title
Evaluation of the effectiveness and safety of a genetically modified live vaccine in broilers challenged with Salmonella Heidelberg
Study date
2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265360
Title
Cross-reactivity between six Enterobacteriaceae co m pl ete I i po po I ysacc h a ride core c h em otypes
Study date
1999
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265371
Title
Immune protection of chickens conferred by a vaccine consisting of attenuated strains of Salmonella Enteritidis, Typhimurium and Infantis
Study date
2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265362
Title
Comparative evaluation of a bivalent killed Salmonella vaccine to prevent egg contamination with Salmonella enterica serovars Enteritidis, Typhimurium, and Gallinarum biovar Pullorum, using 4 different challenge models
Study date
2007
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265363
Title
Effects of Salmonella enterica subsp. enterica serovar Enteritidis vaccination in layer hens subjected to S. Enteritidis challenge and various feed withdrawal regimens
Study date
2007
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265364
Title
Functional Activity of Antibodies Directed towards Flagellin Proteins of Non-Typhoidal Salmonella
Study date
2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265365
Title
Salmonella enterica Serovar Enteritidis Core O Polysaccharide Conjugated to H:g,m Flagellin as a Candidate Vaccine for Protection against Invasive Infection with S. Enteritidis
Study date
2011
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265366
Title
Protection mediated by antibodies to iron-regulated outer-membrane proteins of S. typhi in a mouse peritonitis model
Study date
2005
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265367
Title
Extracellular Antigens from Salmonella enteritidis Induce Effective Immune Response in Mice after Oral Vaccination
Study date
2004
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265368
Title
Mucosal immunization with purified flagellin from Salmonella induces systemic and mucosal immune responses in C3H/HeJ mice
Study date
2004
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265369
Title
Escherichia and Salmonella Receptor 2, Is a Signaling Receptor for Toll-Like Receptor 4, But Not Toll-Like Lipopolysaccharides
Study date
2000
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265370
Title
Characterization and whole genome sequencing of closely related multidrugresistant Salmonella enterica serovar Heidelberg isolates from imported poultry meat in the Netherlands
Study date
2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265372
Title
Salmonella enterica in the chicken: how it has helped our understanding of immunology in a non-biomedical model species
Study date
2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265361
Title
All Accessible Epitopes in the Salmonella Lipopolysaccharide Core Are Associated with Branch Residues
Study date
1999
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265354
Title
Salmonella control in poultry flocks and its public health impact
Study date
2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265355
Title
Extended-Spectrum Cephalosporin- Resistant Salmonella enterica serovar Heidelberg Strains, the Netherlands
Study date
2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265356
Title
Structural diversity in Salmonella O antigens and its genetic basis
Study date
2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265349
Title
Salmonella Serogroup C: Current Status of Vaccines and Why They Are Needed
Study date
2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265351
Title
Igg Subclasses Targeting the Flagella of Salmonella enterica Serovar Typhimurium Can Mediate Phagocytosis and Bacterial Killing
Study date
2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265346
Title
The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2016
Study date
2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265343
Title
Poultry producers fall foul of Salmonella enteritidis
Study date
1988
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265344
Title
Invasiveness and Persistence of Salmonella enteritidis, Salmonella typhimurium, and a Genetically Defined S. enteritidis aroA Strain in Young Chickens
Study date
1994
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265340
Title
Comparitive studies on the toxicity of Escherichia coli lipopolysaccharide endotoxin in various animal species
Study date
1996
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265329
Title
Efficacy and Safety field trial in broiler breeders
Study date
29 August 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265290
Title
Safety testing of Salenvac TC
Study date
25 July 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265291
Title
Poultry records book
Study date
2 September 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265292
Title
Safety Testing of Salenvac ETC
Study date
9 May 2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265293
Title
Poultry records book
Study date
17 December 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265294
Title
Safety Testing of Salenvac TC
Study date
2 Apr 2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265295
Title
Poultry records book
Study date
22 October 2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265122
Title
DACS on Safety Tests
Study date
11 March 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265347
Title
The European Union summary report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2014
Study date
2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285234
Title
Statistical analysis of the method transfer of the Potency ELISA for Salmonella enteritidis in Salenvac ETC from QC MK to QC K
Study date
March 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265105
Title
Reference for APVMA to appendices
Study date
January 2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265106
Title
P2.1 Registration overview
Study date
7 March 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265116
Title
Summary of product characteristics and labelling
Study date
December 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267490
Title
DAFF Permit Application
Study date
December 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
265107
Title
P2.2 Biological Product Summary Sheet Salenvac ETC
Study date
19 September 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
142569
Product/Active constituent Name
Application Product Name
Salmonella Infantis strain S03499-06
Application Date
Application Number
142569
Application Product Name
Salmonella Infantis strain S03499-06
Application details
Product name:
Salmonella Infantis strain S03499-06
Product number:
94485
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a trivalent Salmonella vaccine for injection for chickens.
Approval of three salmonella active constituents.
Description of data provided:
Data no
267576
Title
Validation of S. Infantis (SI) inactivation
Study date
16 October 2014
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267577
Title
SI assay validation
Study date
13 November 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267578
Title
SI IRP profile-method validation
Study date
3 November 2017
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267579
Title
Confirmation of identity of Salmonella infantis
Study date
20 June 2013
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267580
Title
Standard Operating Procedure: GRA-TI-QC-205
Study date
January 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267582
Title
Ag. summary protocol SI Batch LSIN0011
Study date
11 April 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267584
Title
SI master seed testing
Study date
5 February 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267585
Title
SI production seed CoA
Study date
17 January 2019
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267583
Title
SI master seed preparation
Study date
12 June 2012
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267574
Title
Salmonella infantis inactivation kinetics at 30L scale
Study date
18 May 2016
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267575
Title
Salmonella infantis inactivation kinetics 3000L scale
Study date
20 December 2018
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
267581
Title
Ag. summary protocol SI Batch LSIN0009
Study date
26 January 2023
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
142978
Product/Active constituent Name
Application Product Name
TEPPAN 50SL Insecticide
Application Date
Application Number
142978
Application Product Name
TEPPAN 50SL Insecticide
Application details
Product name:
TEPPAN 50SL Insecticide
Product number:
68689
Applicant Name:
ISHIHARA SANGYO KAISHA, LTD
Application purpose and description of use:
Variation of product registration and label approval to include the use of the product on avocado crops.
Active constituents:
Active constituent name
70026 - CYCLANILIPROLE
Description of data provided:
Data no
267505
Title
Evaluation of NUL3445 for the control of spotting bug species in avocados
Study date
May 2021
Data no
267506
Title
Evaluation of NUL3445 for the control of spotting bug species in avocados
Study date
July 2022
Data no
267507
Title
Evaluation of NUL3445 for the control of spotting bug species in avocados
Study date
Jan 2020
Data no
267508
Title
Evaluation of NUL3445 for the control of spotting bug species in avocados
Study date
April 2021
Data no
267509
Title
Evaluation of NUL3445 for the control of spotting bug species in avocados
Study date
June 2021
Data no
267510
Title
Evaluation of experimental insecticides for the control of insect pests in avocado
Study date
July 2022
Data no
267511
Title
Efficacy of NUL3445 on Spotting Bug in Macadamia
Study date
June 2021
Data no
267512
Title
Efficacy of NUL3445 on Spotting Bug in Macadamia
Study date
Feb 2022
Data no
267513
Title
Efficacy of NUL3445 on Spotting Bug in Macadamia
Study date
Feb 2021
Data no
267514
Title
Evaluation of NUL3445 for the control of fruit spotting bug in Macadamia
Study date
Dec 2012
Data no
267503
Title
Crop Safety and Efficacy: TEPPAN 50 SL label extension for use in avocados
Study date
Feb 2024
Data no
267515
Title
Evaluation of NUL3445 residues and its metabolites in avocado
Study date
Jan 2022
Data no
267516
Title
Evaluation of NUL3445 residues and its metabolites in avocado
Study date
June 2023
Data no
267517
Title
Evaluation of NUL3445 for the control of spotting bug species in avocados
Study date
May 2021
Data no
267518
Title
Evaluation of NUL3445 for the control of spotting bug species in avocados
Study date
July 2022
Data no
267519
Title
Evaluation of NUL3445 for the control of spotting bug species in avocados
Study date
Jan 2020
Data no
267520
Title
Evaluation of NUL3445 for the control of spotting bug species in avocados
Study date
April 2021
Data no
267521
Title
Evaluation of NUL3445 for the control of spotting bug species in avocados
Study date
June 2021
Data no
267522
Title
Evaluation of experimental insecticides for the control of insect pests in avocado
Study date
July 2022
Data no
267502
Title
Executive Summary DC14-32188343 ??? TEPPAN?? 50SL Insecticide
Study date
22 Jan 2024
Data no
267504
Title
Teppan 50 SL draft label
Study date
April 2023
Data no
267497
Title
Evaluation of NUL3445 residues and its metabolites in avocado
Study date
12 Jan 2022
Data no
267498
Title
Analytical Phase Report, Evaluation of NUL3445 residues and its metabolites in avocado
Study date
18 Nov 2021
Data no
267499
Title
Evaluation of NUL3445 residues and its metabolites in avocado
Study date
8 Jan 2023
Data no
267500
Title
Analytical Phase Report, Evaluation of NUL3445 residues and its metabolites in avocado - Amended
Study date
25 May 2023
Data no
267501
Title
MODULE - RESIDUES 4 TEPPAN?? 50SL INSECTICIDE
Study date
June 2023