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

152769
Product/Active constituent Name

Application Product Name

Fluxapyroxad

Application details

Product name:

Fluxapyroxad

Active name:

Fluxapyroxad

Applicant Name:

JIANGSU AGROCHEM LABORATORY CO LTD

Application purpose and description of use:

Approval of Fluxapyroxad for use in agricultural and veterinary chemical products.

Description of data provided:

Data no
304920
Author
Carrie Zhang
Title
Declaration of Composition
Study date
02/04/2026
Authorising party
Applicant
Auth party contact address
1218 NORTH CHANGJIANG ROAD WEITANG CHEMICAL INDUSTRY PARK XINBEI DISTRICT CHANGZHOU, JIANGSU PROVINCE China
Data no
304921
Author
Carrie Zhang
Title
Data list of Fluxapyroxad TC
Study date
02/04/2026
Authorising party
Applicant
Auth party contact address
1218 NORTH CHANGJIANG ROAD WEITANG CHEMICAL INDUSTRY PARK XINBEI DISTRICT CHANGZHOU, JIANGSU PROVINCE China
Data no
304918
Author
Wendy Wang W.
Title
Study 0984 Five Batches Analysis of Fluxapyroxad Technical
Study date
16/01/2026
Authorising party
Applicant
Auth party contact address
1218 NORTH CHANGJIANG ROAD WEITANG CHEMICAL INDUSTRY PARK XINBEI DISTRICT CHANGZHOU, JIANGSU PROVINCE China
Data no
304919
Author
Yonghui Sun
Title
Method of manufacture of Fluxapyroxad Technical
Study date
18/02/2025
Authorising party
Applicant
Auth party contact address
1218 NORTH CHANGJIANG ROAD WEITANG CHEMICAL INDUSTRY PARK XINBEI DISTRICT CHANGZHOU, JIANGSU PROVINCE China
Data no
304917
Author
Wendy Wang W.
Title
Five Batches Analysis Conclusion
Study date
16/01/2026
Authorising party
Applicant
Auth party contact address
1218 NORTH CHANGJIANG ROAD WEITANG CHEMICAL INDUSTRY PARK XINBEI DISTRICT CHANGZHOU, JIANGSU PROVINCE China
Date

Application Date

Application No

Application Number

153233
Product/Active constituent Name

Application Product Name

BOMECTIN F BROAD-SPECTRUM ANTIPARASITIC INJECTION FOR CATTLE

Application details

Product name:

BOMECTIN F BROAD-SPECTRUM ANTIPARASITIC INJECTION FOR CATTLE

Product number:

62967

Applicant Name:

ELANCO AUSTRALASIA PTY LTD

Application purpose and description of use:

Variation of product registration to update product label.

Active constituents:

Active constituent name
84117 - Clorsulon
Active constituent name
96631 - Clorsulon
Date

Application Date

Application No

Application Number

152671
Product/Active constituent Name

Application Product Name

EXIT-R HERBICIDE

Application details

Product name:

EXIT-R HERBICIDE

Applicant Name:

PKB INTENSIVE ANIMAL SERVICES PTY LTD

Application purpose and description of use:

Registration of a 850g/kg pyroxasulfone WG product for the proposed uses as described in the directions for use section of the label.
Date

Application Date

Application No

Application Number

152716
Product/Active constituent Name

Application Product Name

Trezac Arylex active Herbicide

Application details

Product name:

Trezac Arylex active Herbicide

Product number:

88180

Applicant Name:

CORTEVA AGRISCIENCE AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration to add use in forage brassicas.

Active constituents:

Active constituent name
68243 - HALAUXIFEN-METHYL
Active constituent name
68286 - HALAUXIFEN-METHYL
Active constituent name
59174 - AMINOPYRALID
Active constituent name
82776 - Aminopyralid
Active constituent name
82159 - cloquintocet-mexyl

Description of data provided:

Data no
304755
Author
Love, C.
Title
Trezac part 8 efficacy. Dow AgroSciences Australia Ltd
Study date
2019
Data no
304756
Author
Nott, P.
Title
GF-2685 WG (XDE-729) efficacy data and information (Australia only). Dow AgroSciences Australia Ltd
Study date
2012
Data no
304757
Author
Lamond, T.
Title
GF-3013 (ForageMax) efficacy data and information. Dow AgroSciences Australia Ltd
Study date
2012
Data no
304758
Author
Wells, G.
Title
GF-3013SC (ForageMax herbicide) part 8 efficacy and crop safety. Dow AgroSciences Australia Ltd
Study date
2015
Data no
304759
Author
Wells, G.
Title
GF-3013SC (ForageMax herbicide) part 8 efficacy and crop safety. Dow AgroSciences Australia Ltd
Study date
2017
Data no
304740
Author
Holding, R.
Title
Trezac forage brassica weed efficacy, Australia, 2024
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304751
Author
R. N. James
Title
Aminopyralid Residues in New Zealand Forage Brassicas 2006
Study date
2008
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304737
Author
Plater, C. and Nott, P.
Title
ForageMax (GF-3013) for control of cleavers, poppies, shepherd???s purse and small flowered mallow, Australia 2013-15
Study date
2015
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304743
Author
Wells, G.
Title
Trezac forage brassica selectivity, Breeza, Australia, 2024
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304754
Author
S. L. Rotondaro, J. A. Taylor, J. L. Balcer, A. N. Grotenhuis, L. K. Graper
Title
A Nature of the Residue Study with [14C]-XDE-729 Methyl Applied to Turnips; Study ID: 110413
Study date
2012
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304760
Author
Anon.
Title
Excellent ROI from forage brassicas. Rural Business, December, 2016
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
304734
Author
Elias, N., Nott, P. and Welsh, M.
Title
Aminopyralid + XDE-729 Methyl (Arylex) capeweed, fababeans and chickpea control, Australia 2010-11
Study date
2012
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304738
Author
Nott, P.
Title
Aminopyralid + XDE-729 Methyl fat hen control and brassica selectivity, Australia 2008-11
Study date
2012
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304746
Author
Tennent, J.
Title
Trezac forage brassica selectivity, Numurkah, Australia, 2025
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304749
Author
D. Litzow
Title
Residues of XDE-729 and aminopyralid in Brassicas Australia and New Zealand 2011, Study Number: DOWAUS/GLP/11/09
Study date
2012
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304735
Author
Nott, P.
Title
XDE-729 methyl (as GF-2685) efficacy, Australia, 2009-11
Study date
2012
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304752
Author
A. Ascough
Title
Magnitude of Residues of cloquintocet-mexyl in Brassica Following Foliar Applications of Trezac Arylex active herbicide, Study Number: 24-AAC-002
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304732
Author
G. Wells
Title
Part 8: Efficacy and CropSafety
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304744
Author
Kohler, D.
Title
Trezac forage brassica selectivity, Forth, Australia, 2024
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304753
Author
P. Solomon
Title
Magnitude of Residues of cloquintocet-mexyl in Brassica Following Foliar Applications of Trezac Arylex active herbicide; Study Number: 24-AAC-002
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304733
Author
A. Jaszewski
Title
Part 5A&B: Residues & Trade
Study date
2026
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304741
Author
Kohler, D.
Title
Trezac forage brassica weed efficacy ??? long headed poppy, Australia, 2024
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304747
Author
Gunn, T.
Title
Efficacy of Trezac on TMax resistant fat hen, Waireka, New Zealand, 2025
Study date
2026
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304750
Author
D. Litzow
Title
Residues of XDE-729 and aminopyralid in Brassicas Australia and New Zealand 2011, Study Number: DOWAUS/GLP/11/09
Study date
2012
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304742
Author
Kohler, D.
Title
Trezac forage brassica weed efficacy ??? black nightshade, Australia, 2024
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304748
Author
D. Litzow
Title
Residues of XDE-729 and aminopyralid in Brassicas Australia 2010, Study Number: DOWAUS/GLP/10/19
Study date
2012
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304739
Author
Kohler, D.
Title
Trezac forage brassica weed efficacy ??? fat hen, Australia, 2024
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304745
Author
Gunn, T.
Title
Trezac forage brassica selectivity, Waireka, New Zealand, 2025
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Data no
304736
Author
Nott, P.
Title
Aminopyralid + XDE-729 methyl cleaver control
Study date
2012
Authorising party
Applicant
Auth party contact address
LEVEL 9, 67 Albert Avenue CHATSWOOD Australia
Date

Application Date

Application No

Application Number

152747
Product/Active constituent Name

Application Product Name

WeedBan Fluroxypyr 400 EC Herbicide

Application details

Product name:

WeedBan Fluroxypyr 400 EC Herbicide

Applicant Name:

Jiangsu Flag Chemical Industry Co Ltd

Application purpose and description of use:

Registration of a 400 g/L fluroxypyr present as the methyl heptyl ester emulsifiable concentrate product for the control of a wide range of broadleaf weeds in Fallow, Lucerne, Maize, Millets, Pastures, Poppies, Sorghum, Sugar Cane, Sweet Corn and Winter Cereals. Also for the control of woody weeds in agricultural non-crop areas, commercial and industrial areas, forests, pastures and rights-of-way.
Date

Application Date

Application No

Application Number

152758
Product/Active constituent Name

Application Product Name

FLORFENICOL

Application details

Product name:

FLORFENICOL

Active name:

FLORFENICOL

Applicant Name:

PAH AUSTRALIA PTY LTD

Application purpose and description of use:

Approval of florfenicol for use in veterinary chemical products.

Description of data provided:

Data no
303752
Author
Not Identified
Title
DMF 3.2.S.2
Study date
2025
Authorising party
Applicant
Auth party contact address
20 Buontempo Road CARRUM DOWNS Australia
Data no
303750
Author
Anon
Title
Certificates of analysis
Study date
2025
Authorising party
Applicant
Auth party contact address
20 Buontempo Road CARRUM DOWNS Australia
Data no
303751
Author
Anon
Title
DMF
Study date
2025
Authorising party
Applicant
Auth party contact address
20 Buontempo Road CARRUM DOWNS Australia
Data no
304327
Author
Anon
Title
Report
Study date
2026
Authorising party
Applicant
Auth party contact address
20 Buontempo Road CARRUM DOWNS Australia
Date

Application Date

Application No

Application Number

152767
Product/Active constituent Name

Application Product Name

Pyroxasulfone

Application details

Product name:

Pyroxasulfone

Active name:

Pyroxasulfone

Applicant Name:

PARIJAT INDUSTRIES (INDIA) LIMITED

Application purpose and description of use:

Approval of pyroxasulfone for use in agricultural chemical products.

Description of data provided:

Data no
304909
Author
Chaithanya, V.
Title
Five Batch Analysis of Pyroxasulfone Technical
Study date
8 August 2025
Authorising party
Applicant
Auth party contact address
M-77, 1st & 2nd Floor M Block Market Greater Kailash-II NEW DEHLI India
Data no
304912
Author
Parijat Industries (India) Limited
Title
Declaration of Composition - Manufacturer
Study date
23 March 2026
Authorising party
Applicant
Auth party contact address
M-77, 1st & 2nd Floor M Block Market Greater Kailash-II NEW DEHLI India
Data no
304913
Author
Parijat Industries (India) Limited
Title
Certificate of Composition
Study date
27 March 2026
Authorising party
Applicant
Auth party contact address
M-77, 1st & 2nd Floor M Block Market Greater Kailash-II NEW DEHLI India
Data no
304910
Author
Parijat Industries (India) Limited
Title
Manufacturing Method
Study date
24 March 2026
Authorising party
Applicant
Auth party contact address
M-77, 1st & 2nd Floor M Block Market Greater Kailash-II NEW DEHLI India
Data no
304911
Author
Parijat Industries (India) Limited
Title
Declaration of Composition -signed
Study date
27 March 2026
Authorising party
Applicant
Auth party contact address
M-77, 1st & 2nd Floor M Block Market Greater Kailash-II NEW DEHLI India
Data no
304908
Author
Parijat Industries (India) Limited
Title
Part 2 Chemistry and Manufacturing
Study date
27 March 2026
Authorising party
Applicant
Auth party contact address
M-77, 1st & 2nd Floor M Block Market Greater Kailash-II NEW DEHLI India
Data no
304914
Author
Parijat Industries (India) Limited
Title
Batch Sizes
Study date
27 March 2026
Authorising party
Applicant
Auth party contact address
M-77, 1st & 2nd Floor M Block Market Greater Kailash-II NEW DEHLI India
Date

Application Date

Application No

Application Number

152768
Product/Active constituent Name

Application Product Name

NAADCO Clethodim 360 EC Herbicide

Application details

Product name:

NAADCO Clethodim 360 EC Herbicide

Applicant Name:

NEW AUSTRALIA AGRICULTURAL DEVELOPMENT COMPANY PTY LTD

Application purpose and description of use:

Registration of a 360g/L Clethodim Emulsifiable concentrate product for the control of certain grass weeds in beetroot, cabbage, canola, celery, cotton, forestry, lettuce, non-bearing fruit trees, onions, ornamentals, peanuts, pulses (including adzuki beans, broad beans, chickpeas, faba beans, field peas, lentils, lupins and mung beans), potatoes, soybeans, and pasture legume (lucerne, clover and medic) seed crops and pastures (including pastures containing chicory and plantain) as per the Directions for Use table.
Date

Application Date

Application No

Application Number

153204
Product/Active constituent Name

Application Product Name

ENVIROMAX PERMETHRIN 500EC RESIDUAL INSECTICIDE B

Application details

Product name:

ENVIROMAX PERMETHRIN 500EC RESIDUAL INSECTICIDE B

Applicant Name:

ENVIROMAX TECHNOLOGIES PTY LTD

Application purpose and description of use:

Registration of a 500 g/L permethrin emulsifiable concentrate product for control of a range of insect pests in various situations.
Date

Application Date

Application No

Application Number

152778
Product/Active constituent Name

Application Product Name

Chlorantraniliprole

Application details

Product name:

Chlorantraniliprole

Active name:

Chlorantraniliprole

Applicant Name:

AGROSENSE BIOTECH PTY LTD

Application purpose and description of use:

Approval of Chlorantraniliprole for use in agricultural chemical products.

Description of data provided:

Data no
304932
Author
Guangdong Liwei Chemical Industry Co., Ltd.
Title
Five batch RF.19805.030.036.23 - EN - Non-confidential
Study date
July 10, 2024
Authorising party
Applicant
Auth party contact address
68 Linden Way Bella Vista Australia
Data no
304935
Author
Guangdong Liwei Chemical Industry Co., Ltd.
Title
Physical and chemical properties of Chlorantraniliprole
Study date
March 30, 2026
Authorising party
Applicant
Auth party contact address
68 Linden Way Bella Vista Australia
Data no
304938
Author
Guangdong Liwei Chemical Industry Co., Ltd.
Title
The statement of batch size of Chlorantraniliprole technical in 5-batch report
Study date
March 30, 2026
Authorising party
Applicant
Auth party contact address
68 Linden Way Bella Vista Australia
Data no
304933
Author
Guangdong Liwei Chemical Industry Co., Ltd.
Title
Five batch RF. EPA 19805.030.036.23 - Confidential
Study date
July 10, 2024
Authorising party
Applicant
Auth party contact address
68 Linden Way Bella Vista Australia
Data no
304936
Author
Guangdong Liwei Chemical Industry Co., Ltd.
Title
DoC of Chlorantraniliprole TC
Study date
March 30, 2026
Authorising party
Applicant
Auth party contact address
68 Linden Way Bella Vista Australia
Data no
304937
Author
Guangdong Liwei Chemical Industry Co., Ltd.
Title
Registration Data of Chlorantraniliprole
Study date
March 30, 2026
Authorising party
Applicant
Auth party contact address
68 Linden Way Bella Vista Australia
Data no
304934
Author
Guangdong Liwei Chemical Industry Co., Ltd.
Title
Manufacturer process and Impurities Justification of Chlorantraniliprole TC
Study date
March 30, 2026
Authorising party
Applicant
Auth party contact address
68 Linden Way Bella Vista Australia
Date

Application Date

Application No

Application Number

152916
Product/Active constituent Name

Application Product Name

Imidacloprid

Application details

Product name:

Imidacloprid

Active name:

Imidacloprid

Applicant Name:

AGRO-ALLIANCE (AUSTRALIA) PTY LTD

Application purpose and description of use:

Approval of Imidacloprid for use in veterinary chemical products.

Description of data provided:

Data no
304047
Author
Anon
Title
Description of formation of impurities in Imidacloprid
Study date
04/2026
Authorising party
Applicant
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
304044
Author
Anon
Title
Drug Master File
Study date
04/2026
Authorising party
Applicant
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
304045
Author
Anon
Title
Certificates of analysis
Study date
08/01/2026
Authorising party
Applicant
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
304048
Author
Anon
Title
Process Validation Report
Study date
04/2026
Authorising party
Applicant
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
304046
Author
Anon
Title
Composition of Imidacloprid
Study date
04/2026
Authorising party
Applicant
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
304049
Author
Anon
Title
Chromatograms
Study date
04/2026
Authorising party
Applicant
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Date

Application Date

Application No

Application Number

152807
Product/Active constituent Name

Application Product Name

Cardisure 3.5mg/ml Oral Solution for Dogs

Application details

Product name:

Cardisure 3.5mg/ml Oral Solution for Dogs

Applicant Name:

LUODA PHARMA PTY LTD

Application purpose and description of use:

Registration of a 3,5 mg/mL oral solution of pimobendan for administration to dogs for the treatment of congestive heart failure or preclinical dilated cardiomyopathy..
Date

Application Date

Application No

Application Number

152608
Product/Active constituent Name

Application Product Name

EuroChem NINJA MEALYBUG Control Insecticide

Application details

Product name:

EuroChem NINJA MEALYBUG Control Insecticide

Product number:

97286

Applicant Name:

EUROCHEM PTY. LTD.

Application purpose and description of use:

This submission is for the registration of a new agchem product called “EuroChem NINJA MEALYBUG Control Insecticide”, which is a 500 g/kg CLOTHIANIDIN Water Dispersible Granule (WG) Insecticide product for the control of Carob moth and Carpophilus beetle in Almonds; Mealybug, Woolly aphid and Codling moth in Apples and Pears; Gall wasp, Leaf miner, Fullers rose weevil and California red scale in Citrus; Green peach aphid and Oriental fruit moth in Peaches and Nectarines; Queensland and Mediterranean Fruit Fly in Table grapes, Persimmon, Pome fruit and Stone fruit; Carpophilus beetle in Stone fruit; Mealybug in Grapes; and Grapevine scale in Wine grapes as specified in the DIRECTIONS FOR USE table.

Reference details:

60687 - SUMITOMO SAMURAI SYSTEMIC INSECTICIDE

Active constituents:

Active constituent name
70306 - CLOTHIANIDIN
Active constituent name
68154 - CLOTHIANIDIN

Description of data provided:

Data no
304210
Author
Jake Gillmore
Title
PCT Clothianidin ??? Citrus
Study date
19/1/2026
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304202
Author
A. Yarnton
Title
Part 2.3 - Appendix 2Cb - ACS1715306
Study date
28/09/2017
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304196
Author
unknown
Title
Part 2.3 Chemistry and Manufacture Dossier for the Registration of EuroChem NINJA MEALYBUG Control Insecticide Report No PGR-0750-1 - v3
Study date
23/03/2026
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304199
Author
Ania Yarnton
Title
Part 2.3 - Appendix 2A - ACS-VR-227-1 Clothianidin (500 WG) Method
Study date
29/09/2017
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304197
Author
unknown
Title
Part 2.3 - Appendix 1A - CofA Clothianidin tech Specifications
Study date
8/08/2017
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304208
Author
Jake Gilmore & Shane Harvey
Title
To compare PCT Surefire Clothianidin with Sumitomo Samurai Insecticide in terms of bioequivalence for carob moth control and crop safety in almonds as per the Sumitomo Samurai Insecticide at label rates and double (2X) rates.
Study date
23/6/2025
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304205
Author
Amrit Pannu
Title
EVALUATION OF THE BIO-EQUIVALENCE OF CLOTHIANIDIN FORMULATIONS ONE FIELD TRIAL, SHEPPARTON, VICTORIA, AUSTRALIA, 2019 - V1
Study date
28/3/2019
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304206
Author
Jessica Page
Title
A comparison of the toxicity of two products on 3 pest species found in stone fruit and grapes
Study date
18/1/2021
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304200
Author
Ania Yarnton
Title
Part 2.3 - Appendix 2B - ACS-VR-227-3 Clothianidin technical Method
Study date
07/10/2020
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304209
Author
Jake Gilmore
Title
PCT Clothianidin ??? Apples
Study date
19/1/2026
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304203
Author
unknown
Title
Part 2.3 - Appendix 3 - Raw Material Specifications
Study date
2026
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304204
Author
Unknown
Title
Part 8 EFFICACY and CROP SAFETY DOSSIER FOR THE REGISTRATION OF EuroChem NINJA MEALYBUG Control Insecticide - PGR-0750 - V1
Study date
31/1/2026
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304198
Author
A
Title
Part 2.3 - Appendix 1B - ACS1715426-BA-1 Ronic 5-batch summary
Study date
2025
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304207
Author
Jake Gilmore & Shane Harvey
Title
PCT Clothianidin ??? control of Long Tailed Mealy Bug (Pseudococcus longispinus) in Table and Wine Grapes
Study date
27/2/2025
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Data no
304201
Author
C. Tsibouklis
Title
Part 2.3 - Appendix 2Ca - ACS1715050
Study date
15/08/2017
Authorising party
Applicant
Auth party contact address
9 Heales Road Lara Australia
Date

Application Date

Application No

Application Number

152737
Product/Active constituent Name

Application Product Name

Milestone Fly Spray Fast Knockdown Flying Insect Spray

Application details

Product name:

Milestone Fly Spray Fast Knockdown Flying Insect Spray

Applicant Name:

AARON LABORATORIES PROPRIETARY LIMITED

Application purpose and description of use:

Registration of a 1.0 g/kg ESBIOTHRIN, 0.5 g/kg PERMETHRIN and 0.2 g/kg IMIPROTHRIN aerosol product for control of most flying insects, such as flies, bees, wasps, and mosquitoes and crawling insects, including ants, spiders, and cockroaches.
Date

Application Date

Application No

Application Number

152738
Product/Active constituent Name

Application Product Name

Eurochem Zippo 500 Fungicide

Application details

Product name:

Eurochem Zippo 500 Fungicide

Applicant Name:

EUROCHEM PTY. LTD.

Application purpose and description of use:

Registration of a 500 g/kg water dispersible granule formulation of trifloxystrobin For the control of certain diseases of apples, grapevines, pears and strawberries as specified in the DIRECTIONS FOR USE table.
Date

Application Date

Application No

Application Number

152913
Product/Active constituent Name

Application Product Name

STELFONTA

Application details

Product name:

STELFONTA

Product number:

88412

Applicant Name:

QBIOTICS GROUP LIMITED

Application purpose and description of use:

Variation of product registration to update the Stelfonta shelf-life.

Active constituents:

Active constituent name
88411 - Tigilanol tiglate

Description of data provided:

Data no
304043
Author
Anon
Title
Post MA variation_Shelflife extension
Study date
March 2026
Authorising party
Applicant
Auth party contact address
Level 14, 15 Lakes Street CAIRNS Australia
Date

Application Date

Application No

Application Number

151318
Product/Active constituent Name

Application Product Name

Cell-associated live turkey herpes virus (HVT, Marek’s disease virus), serotype 3, strain FC-126

Application details

Product name:

Cell-associated live turkey herpes virus (HVT, Marek’s disease virus), serotype 3, strain FC-126

Product number:

96949

Applicant Name:

BIOPROPERTIES PTY. LTD.

Application purpose and description of use:

Registration of a 2000pfu/dose Marek's disease virus serotype 3, strain FC-126 frozen liquid vaccine product for reduction of mortality and clinical signs due to Mareks Disease in chickens

Description of data provided:

Data no
302019
Author
Ceva-Phylaxia Co Ltd
Title
HVT (MDV Serotype 3) EU MSV Certificate of Analysis
Study date
2016
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302020
Author
Ceva-Phylaxia Co Ltd
Title
HVT (MDV Serotype 3) WSV Certificate of Analysis
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Date

Application Date

Application No

Application Number

151319
Product/Active constituent Name

Application Product Name

Cevac MD HVT

Application details

Product name:

Cevac MD HVT

Product number:

96950

Applicant Name:

BIOPROPERTIES PTY. LTD.

Application purpose and description of use:

Registration of a 2000pfu/dose Marek's disease virus serotype 3, strain FC-126 frozen liquid vaccine product for reduction of mortality and clinical signs due to Mareks Disease in chickens

Active constituents:

Active constituent name
96949 - Cell-associated live turkey herpes virus (HVT, Marek’s disease virus), serotype 3, strain FC

Description of data provided:

Data no
299330
Author
R Banks
Title
Cevac MD HVT Detailed and Critical Summary on Part 2 Quality Documentation
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299384
Author
Ceva Phylaxia Co Ltd
Title
Complementary MD efficacy testing
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299347
Author
Ceva-Phylaxia Co Ltd
Title
SPF Flock test results
Study date
2022
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299393
Author
Islam AFMF, Walkden-Brown SW, Groves PJ and Underwood GJ
Title
Effects of vaccine dose, virus challenge dose and interval from vaccination to challenge on protection of broiler chickens against Marek's disease virus challenge
Study date
2007
Authorising party
Public
Auth party contact address
-
Data no
299390
Author
Australian Pesticides and Veterinary Medicines Authority
Title
Certificate of Manufacture (approved GMP)
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299327
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD HVT Part 2 Safety Documentation
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299364
Author
Ceva-Phylaxia Co Ltd
Title
Validation of a PCR method
Study date
2016
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299376
Author
Ceva-Phylaxia Co Ltd
Title
FOREIGN SPECIES OVERDOSE SAFETY AND SPREAD
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299370
Author
Animal Health and Veterinary Laboratories Agency
Title
OVERDOSE SAFETY & RESIDUAL PATHOGENICITY
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299333
Author
Spanish Agency of Medicines and Medical Devices
Title
Cevac MD HVT Day 70 Preliminary Assessment Report
Study date
2016
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299350
Author
Free University Berlin Institute of Poultry Diseases
Title
Validation of an ELISA for detection of antibodies to avian nephritis virus
Study date
2005
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299387
Author
Ceva Phylaxia Co Ltd
Title
Complementary MD efficacy testing
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299341
Author
Spanish Agency of Medicines and Medical Devices
Title
Cevac MD HVT ES/V0264/001/R/001 D90 End of Procedure
Study date
2021
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299396
Author
Bioproperties Pty Ltd
Title
Executive Summary: Item 2 Cevac MD HVT
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299344
Author
Spanish Agency of Medicines and Medical Devices
Title
Assessment of the responses to day 15 variation assessment report ES/V/0264/001/IB/005
Study date
2020
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299367
Author
Ceva-Phylaxia Co Ltd
Title
Batch Release Certificates
Study date
2012
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299361
Author
Ceva-Phylaxia Co Ltd
Title
VALIDATION OF TITRATION METHOD
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299373
Author
Ceva-Phylaxia Co Ltd
Title
FOREIGN SPECIES OVERDOSE SAFETY AND SPREAD
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299324
Author
Ceva-Phylaxia Co.Ltd
Title
Cevac MD HVT Summary of product Characteristics
Study date
2021
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299359
Author
Ceva-Phylaxia Co Ltd
Title
Monoclonal antibody specificity test
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299336
Author
Ceva Sante Animale
Title
Pharmacovigilance statement
Study date
2024
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302061
Author
Not Identified
Title
Cevac MD HVT Manufacturing Flowchart
Study date
2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299382
Author
Ceva Phylaxia Co Ltd
Title
V054 VACCINE FIELD SAFETY AND EFFICACY TEST
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299388
Author
Ceva Phylaxia Co Ltd
Title
VALIDATION OF A REAL.TIME QUANTITATIVE PCR ASSAY
Study date
2013
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299342
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD HVT List of Post Authorisation Submissions
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299345
Author
Ceva-Phylaxia Co Ltd
Title
Glass ampule specification and Certificate of Analysis
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299368
Author
Ceva-Phylaxia Co Ltd
Title
STABILITY STUDY
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299362
Author
Ceva-Phylaxia Co Ltd
Title
Validation of a PCR Method
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299325
Author
Ceva-Phylaxia Co.Ltd
Title
Cevac MD HVT Labelling and Package Leaflet
Study date
2021
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299356
Author
Ceva-Phylaxia Co Ltd
Title
serum Certificates of Analysis/Suitability
Study date
2023
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299379
Author
Ceva Phylaxia Co Ltd
Title
EFFICACY OF CEVAC MD HVT VACCINE
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302064
Author
Not Identified
Title
Steps of Manufacture - HVT Site 3
Study date
2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299385
Author
Ceva Phylaxia Co Ltd
Title
Complementary MD efficacy testing
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299339
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD HVT Clinical Expert Statement
Study date
2021
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299348
Author
Ceva-Phylaxia Co Ltd
Title
Technology Transfer Qualification Summary report
Study date
2023
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299391
Author
Bioproperties
Title
Justification for waiving local field trials
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299328
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD HVT Part 4 Efficacy Documentation
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299365
Author
Ceva-Phylaxia Co Ltd
Title
Validation of PGR-based methods
Study date
2012
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299371
Author
Animal Health and Veterinary Laboratories Agency
Title
EXAMINATION OF A MAREK'S DISEASE VACCTNE FOR SHED AND SPREAD
Study date
2012
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299380
Author
Ceva Phylaxia Co Ltd
Title
Efficacy of CEVAC MD HVT vaccine
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299334
Author
Spanish Agency of Medicines and Medical Devices
Title
Cevac MD HVT Day 120 Assessment of the Consolidated List of Questions
Study date
2016
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299357
Author
Ceva-Phylaxia Co Ltd
Title
Validation of the Sterility Test
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299386
Author
Ceva Phylaxia Co Ltd
Title
Complementary MD efficacy testing
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299397
Author
National Food Chain Safety Office
Title
CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER
Study date
2023
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299340
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD HVT Clinical Expert Statement
Study date
2021
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299351
Author
Ceva-Phylaxia Co Ltd
Title
Non-biological materials not listed in PhEur CErtificates of Analysis
Study date
2021
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299374
Author
Ceva-Phylaxia Co Ltd
Title
FOREIGN SPECIES OVERDOSE SAFETY AND SPREAD
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299377
Author
Ceva-Phylaxia Co Ltd
Title
FOREIGN SPECIES OVERDOSE SAFETY AND SPREAD
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299383
Author
Ceva Phylaxia Co Ltd
Title
VACCINE FIELD SAFETY AND EFFICACY TEST
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299354
Author
Ceva-Phylaxia Co Ltd
Title
CoA Origin statement, Irradiation certificate/reports
Study date
2023
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299360
Author
Ceva-Phylaxia Co Ltd
Title
VALIDATION OF TITRATION METHOD
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299331
Author
Dr Rhona Banks FRSB PhD of RA-Elect Ltd
Title
R Banks
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302062
Author
Not Identified
Title
Steps of Manufacture - HVT Site 1
Study date
2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299337
Author
Spanish Agency of Medicines and Medical Devices
Title
Cevac MD HVT Final Assessment Report for Renewal
Study date
2021
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299343
Author
Spanish Agency of Medicines and Medical Devices
Title
Acceptance of Notification ES/V/0264/001/IAin/006
Study date
2020
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299394
Author
Renz KG, Islam AFMF, Cooke J , Clarke N , Cheetham BF et al
Title
Pathotyping of Australian isolates of Mareks disease virus and association of pathogenicity with meq gene polymorphism
Study date
2012
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299363
Author
Ceva-Phylaxia Co Ltd
Title
Complementing Validation of a PCR Method
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302063
Author
Not Identified
Title
Steps of Manufacture - HVT Site 2
Study date
2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299378
Author
Ceva Phylaxia Co Ltd
Title
Efficacy of Cevac MD HVT vaccine
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299355
Author
Ceva-Phylaxia Co Ltd
Title
serum Certificates of Analysis/Suitability
Study date
2023
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299332
Author
R Banks
Title
Cevac MD HVT DEtailed and Critical Summary on Part 3 Efficacy Documentation
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299349
Author
Ceva-Phylaxia Co Ltd
Title
SPF flock test reports
Study date
2023
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299338
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD HVT Quality Expert Statement
Study date
2021
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299395
Author
Ceva Phylaxia
Title
Reg Status and sales data
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299392
Author
Dunn, J.R. and Gimeno, I.M.
Title
Current Status of Marek's Disease in the United States and Worldwide Based on a Questionaire Survey
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
300099
Author
Ceva-Phylaxia Co Ltd
Title
HVT Import Permit Application
Study date
2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299366
Author
Ceva-Phylaxia Co Ltd
Title
VALIDATION OF THE PCR.BASED METHOD
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299372
Author
Ceva-Phylaxia Co Ltd
Title
FOREIGN SPECIES OVERDOSE SAF'ETY AND SPREAD
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299329
Author
European Union member states
Title
Current Marketing Authorisations
Study date
2021
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299335
Author
Spanish Agency of Medicines and Medical Devices
Title
Cevac MD HVT Day 190 Assessment of the day Day 170 responses to the Day 150 CLOQ
Study date
2016
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299358
Author
Ceva-Phylaxia Co Ltd
Title
Validation of the Sterility Test
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299381
Author
Ceva Phylaxia Co Ltd
Title
Efficacy of CEVAC MD HVT vaccine
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299398
Author
Australian Pesticides and Veterinary Medicines Authority
Title
PAA advice and agreement
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299389
Author
Ceva Animal Health
Title
Letter of Authority
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299346
Author
Ceva-Phylaxia Co Ltd
Title
Non-biological Materials Listed in PhEur Certificates of Analysis
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299326
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD HVT Part 2 Chemical, Pharmaceutical and Biological/Microbiological Information (Quality)
Study date
2021
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299375
Author
Ceva-Phylaxia Co Ltd
Title
FOREIGN SPECIES OVERDOSE SAFETY AND SPREAD
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
299369
Author
Ceva-Phylaxia Co Ltd
Title
OVERDOSE SAFETY
Study date
2012
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Date

Application Date

Application No

Application Number

151322
Product/Active constituent Name

Application Product Name

Cell-associated live Marek’s disease virus (MDV) serotype 1, strain CVI-988

Application details

Product name:

Cell-associated live Marek’s disease virus (MDV) serotype 1, strain CVI-988

Product number:

96952

Applicant Name:

BIOPROPERTIES PTY. LTD.

Application purpose and description of use:

Registration of an 800pfu/dose Marek's disease virus serotype 1, strain CVI988 frozen liquid vaccine product for reduction of mortality and clinical signs due to Mareks Disease in chickens.

Description of data provided:

Data no
302050
Author
Ceva-Phylaxia Co Ltd
Title
GENETIC IDENTIFICATION OF Rispens (MDV serotype)
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302021
Author
Ceva-Phylaxia Co Ltd
Title
Rispens (MDV Serotyope 1) EU MSV Certificate of Analysis
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302051
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD Rispens working seed virus WSV Certificate of Analysis
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Date

Application Date

Application No

Application Number

151323
Product/Active constituent Name

Application Product Name

Cevac MD Rispens

Application details

Product name:

Cevac MD Rispens

Product number:

96953

Applicant Name:

BIOPROPERTIES PTY. LTD.

Application purpose and description of use:

Registration of an 800pfu/dose Marek's disease virus serotype 1, strain CVI988 frozen liquid vaccine product for reduction of mortality and clinical signs due to Mareks Disease in chickens.

Active constituents:

Active constituent name
96952 - Cell-associated live Marek’s disease virus (MDV) serotype 1, strain CVI-988

Description of data provided:

Data no
297031
Author
Ceva-Phylaxia Co Ltd
Title
VALIDATION OF THE STERILITY TEST
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297054
Author
Ceva Phylaxia Co Ltd
Title
VALIDATION OF A REAL.TIME QUANTITATIVE PCR ASSAY
Study date
2013
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297037
Author
Ceva-Phylaxia Co Ltd
Title
Validation of PGR-based methods
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297020
Author
Ceva-Phylaxia Co Ltd
Title
Non-biological Materials isted in PhEur SPF flock testing
Study date
2023
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297043
Author
Ceva-Phylaxia Co Ltd
Title
RESIDUAL PATHOGENICITY TEST OF THE MSV
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302069
Author
Not Identified
Title
Steps of Manufacture - MD Rispens Site 2
Study date
2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297014
Author
Spanish Agency of Medicines and Medical Devices
Title
Cevac MD Rispens DAY 190 RMS ASSESSMENT OF THE DAY 170 APPLICANT`S RESPONSE TO THE DAY 150 CONSOLIDATED LIST OF QUESTIONS
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297051
Author
Ceva-Phylaxia Co Ltd
Title
Complementary MD efficacy test of V075 vaccine
Study date
2017
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297057
Author
Bioproperties Pty Ltd
Title
Justification for waiving of local field trials.
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297040
Author
Ceva-Phylaxia Co Ltd
Title
STABILITY STUDY OF CEVAC MD RISPENS VACCINE
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297034
Author
Ceva-Phylaxia Co Ltd
Title
Validation Report of a PCR Method
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297017
Author
Ceva-Phylaxia Co Ltd
Title
List pf Post Authorization Submissions
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297023
Author
Free University Berlin Institute of Poultry Diseases
Title
Validation of an ELISA
Study date
2005
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297003
Author
Ceva-Phylaxia Co Ltd
Title
Summary of Product Characteristics
Study date
2020
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297011
Author
R Banks
Title
Cevac MD Rispens Detailed and Critical Summary on Part 4 Efficacy Documentation
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297060
Author
Ceva Phylaxia Co Ltd
Title
Registration Status and Sales Data
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297029
Author
Ceva-Phylaxia Co Ltd
Title
Serum Certificates of Suitability/Analysis
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297035
Author
Ceva-Phylaxia Co Ltd
Title
Validation Report of PCR
Study date
2011
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297018
Author
Ceva-Phylaxia Co Ltd
Title
Ampule Specifications
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297049
Author
Ceva-Phylaxia Co Ltd
Title
EFFICACY OF V075 VACCINE
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297061
Author
Bioproperties Pty Ltd
Title
Executive Summary: Item 2 Cevac MD Rispens
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302067
Author
Not Identified
Title
Cevac MD Rispens Manufacturing Flowchart
Study date
2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297006
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD Rispens PART 3 Safety Documentation
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297012
Author
Spanish Agency of Medicines and Medical Devices
Title
PRELIMINARY ASSESMENT REPORT
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297032
Author
Ceva-Phylaxia Co Ltd
Title
Monoclonal antibody specificity test
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297055
Author
Ceva Animal Health
Title
Letter of Authority
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297038
Author
Ceva-Phylaxia Co Ltd
Title
REPORT ON THE VALIDATION OF THE PCR.BASED METHOD
Study date
2013
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302070
Author
Not Identified
Title
Steps of Manufacture - MD Rispens Site 3
Study date
2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297046
Author
Ceva-Phylaxia Co Ltd
Title
INCREASE IN VIRULENCE TEST OF THE MSV
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297015
Author
Ceva Sante Animale
Title
CEVAC RISPENS PHARMACOVIGILANCE REPORT
Study date
2024
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297052
Author
Ceva-Phylaxia Co Ltd
Title
FIELD SAFETY AND EFFICACY TRIAL OF V075 VACCINE
Study date
2017
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297009
Author
R Banks
Title
Cevac MD Rispens Detailed and Critical Summary on Part 2 Quality Documentation
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297058
Author
Dunn JR and Gimeno IM
Title
Current Status of Marek's Disease in the United States and Worldwide Based on a Questionnaire Survey
Study date
2013
Authorising party
Public
Auth party contact address
-
Data no
297033
Author
Ceva-Phylaxia Co Ltd
Title
VALIDITATION OF THE TITRATION METHOD
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297041
Author
Ceva-Phylaxia Co Ltd
Title
In use stability study of Cevac MD Rispens vaccine
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297047
Author
Ceva-Phylaxia Co Ltd
Title
INCREASE IN VIRULENCE TEST OF THE MSV
Study date
2016
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297024
Author
Ceva-Phylaxia Co Ltd
Title
Non-biological Material not listed in PhEur Certificates of Analysis
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297004
Author
Ceva-Phylaxia Co Ltd
Title
Label and Leaflet
Study date
2020
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297053
Author
Ceva Phylaxia Co Ltd
Title
Complementary MD efficacy test
Study date
2017
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297010
Author
R Banks
Title
Cevac MD Rispens Detailed and Critical Summary on Part 3 Safety Documentation
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297030
Author
Ceva-Phylaxia Co Ltd
Title
Serum Certificates of Suitability/Analysis
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297044
Author
Ceva-Phylaxia Co Ltd
Title
SPREAD TEST OF V075 VACCINE
Study date
2016
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297021
Author
Ceva-Phylaxia Co Ltd
Title
Technology Transfer Qualification Summary Report
Study date
2023
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297050
Author
Ceva-Phylaxia Co Ltd
Title
FIELD SAFETY AND EFFICACY TRIAL OF V075 VACCINE
Study date
2017
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297013
Author
Spanish Agency of Medicines and Medical Devices
Title
Cevac MD Rispens DAY 120 RMS ASSESSMENT OF THE APPLICANT'S RESPONSE TO THE DAY 105 CONSOLIDATED LIST OF QUESTIONS
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302068
Author
Not Identified
Title
Steps of Manufacture - MD Rispens Site 1
Study date
2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297007
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD Rispens PART 4 Efficacy documentation
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297056
Author
Australian Pesticides and Veterinary Medicines Authority
Title
Certificate of Manufacture (Approved GMP)
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297039
Author
Ceva-Phylaxia Co Ltd
Title
Batch Release Certificates
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297022
Author
Ceva-Phylaxia Co Ltd
Title
SPF Flock test results
Study date
2022
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297045
Author
Ceva-Phylaxia Co Ltd
Title
SPREAD, SHED AND DISSEMINATION STUDY OF THE MSV
Study date
2014
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297016
Author
National Food Chain Safety Office
Title
CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER
Study date
2023
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297059
Author
Renz KG, Cooke J, Clarke N, Cheetham BF, Hussain Z, Islam AFMF, Tannock GA and Walkden-Brown SW
Title
Pathotyping of Australian isolates of Mareks disease virus and association of pathogenicity with meq gene polymorphism
Study date
2012
Authorising party
Public
Auth party contact address
-
Data no
297008
Author
European Union Member States
Title
Marketing Authorisations
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297028
Author
Ceva-Phylaxia Co Ltd
Title
CoA Origin statement/Irradiation certificate
Study date
2023
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297036
Author
Ceva-Phylaxia Co Ltd
Title
Validation of a PCR Method
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297042
Author
Ceva-Phylaxia Co Ltd
Title
SAFETY TEST OF V075 VACCINE
Study date
2016
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297048
Author
Ceva-Phylaxia Co Ltd
Title
EFFICACY OF V075 VACCINE
Study date
2015
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297019
Author
Ceva-Phylaxia Co Ltd
Title
Non-biological Material listed in PhEur Certificates of Analysis
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297062
Author
Australian Pesticides and Veterinary Medicines Authority
Title
62 Rispens PAA and Agreement
Study date
2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
302066
Author
DAFF
Title
MD Rispens Import Permit Application
Study date
2026
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
297005
Author
Ceva-Phylaxia Co Ltd
Title
Cevac MD Rispens Part 2 CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL/MICROBIOLOGICAL INFORMATION (QUALITY)
Study date
2018
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia