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
150738
Product/Active constituent Name
Application Product Name
Mortein Fast Knockdown Flying Insect Killer
Application Date
Application Number
150738
Application Product Name
Mortein Fast Knockdown Flying Insect Killer
Application details
Product name:
Mortein Fast Knockdown Flying Insect Killer
Product number:
96808
Applicant Name:
VEH AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of a 0.7 g/kg permethrin, 0.5 g/kg transfluthrin aerosol product to kill flying insects in domestic applications.
Active constituents:
Active constituent name
47544 - TRANSFLUTHRIN
Active constituent name
89258 - Permethrin
Description of data provided:
Data no
296246
Title
Stability Report ??? Accelerated (2 weeks)
Study date
19.05.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296247
Title
Quantification of Transfluthrin, Imiporthrin and Permethrin in water-based formulations via High-Performance Liquid Chromatography with Ultra-Biolet Detector (HPLC-UV)
Study date
14.11.2024
Auth party contact address
680 George Street Sydney Australia
Data no
296248
Title
Health Module documents
Study date
16.09.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296249
Title
Efficacy Summary
Study date
10.09.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296250
Title
Peet-Grady Chamber Study to Determine the Knockdown and Kill of Seven Aerosol Formulations against Musca domestica
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296251
Title
Peet-Grady Chamber Study to Determine the Knockdown and Kill of Five Aerosol Formulations against Culex quinquefasciatus
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296252
Title
Laboratory study to determine the Direct Spray Knockdown & Kill of Five Aerosol formulations Against the Mosquito
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296253
Title
Laboratory study to determine the Direct Spray Knockdown & Kill of Five Aerosol formulations Against the House Fly
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296254
Title
Aerosol Spray Test against the American Cockroach (Knockdown Test) Results and Report (2 Second Spray)
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296255
Title
Aerosol Spray Test against the German Cockroach (Knockdown Test) Results and Report
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296256
Title
Laboratory study to Determine the Direct Spray Knockdown & Kill of Three Aerosol Formulations against Spiders ??? one Second Spray
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296257
Title
Laboratory study to Determine the Direct Spray Knockdown & Kill of Five Aerosol Formulations against a Black Ant
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296258
Title
Laboratory study to Determine the Direct Spray Knockdown & Kill of Six Aerosol Formulations against a Brown Ant
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296259
Title
Laboratory study to Determine the Direct Spray Knockdown & Kill of Five Aerosol Formulations against Silverfish
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296260
Title
Laboratory study to Determine the Direct Spray Knockdown & Kill of Two Aerosol formulations Against the Paper Wasp
Study date
16.06.2025
Auth party contact address
680 George Street Sydney Australia
Data no
296261
Title
Aerosol Spray Test Against German Cockroaches (Knockdown Test)
Study date
22.04.08
Auth party contact address
680 George Street Sydney Australia
Data no
296262
Title
Aerosol Spray Test Against American Cockroaches (Knockdown Test)
Study date
22.04.08
Auth party contact address
680 George Street Sydney Australia
Date
Application Date
Application No
Application Number
150776
Product/Active constituent Name
Application Product Name
4 Farmers ProMet Gold
Application Date
Application Number
150776
Application Product Name
4 Farmers ProMet Gold
Application details
Product name:
4 Farmers ProMet Gold
Product number:
96820
Applicant Name:
4 FARMERS AUSTRALIA PTY LTD
Application purpose and description of use:
The purpose of this application is to register a new herbicide product, ProMet Gold, which is an Emulsifiable Concentrate (EC) formulation containing the active constituents: Prosulfocarb 800 g/L and S-Metolachlor 120 g/L.
ProMet Gold is intended for the pre-emergent and early post-emergent control of annual ryegrass (Lolium rigidum) and other grass and broadleaf weeds in a range of crops, including wheat, barley, chickpeas, faba beans, field peas, lentils, lupins, oats, potatoes, and triticale.
This product is bioequivalent to the already registered product Boxer Gold, demonstrating equivalent efficacy, crop safety, and environmental profile. The application seeks approval of the formulation, packaging, and labelling to enable its legal supply, storage, handling, and use in accordance with the Agvet Code and relevant regulations.
Reference details:
61234 - BOXER GOLD HERBICIDE
Active constituents:
Active constituent name
81031 - PROSULFOCARB
Active constituent name
81731 - 4Farmers S-Metolachlor 960 EC Herbicide
Active constituent name
89819 - S-metolachlor
Description of data provided:
Data no
296327
Title
Chemistry and manufacture of 4Farmers ProMet Gold Herbicide
Study date
28/10/2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
296328
Title
Stability Report of 4Farmers ProMet Gold Herbicide
Study date
28/10/2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
296329
Title
Analytical GC assay method for Prosulfocarb and S-Metolachlor
Study date
28/10/2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
296330
Title
Validation of method QCM-071 for the assay of actives Prosulfocarb and S-Metolachlor
Study date
28/10/2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
296331
Title
SDS's of 4Farmers ProMet Gold EC Components
Study date
2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
296332
Title
Certificate of Analysis of the active materials
Study date
2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
296333
Title
GHS classification of 4Farmers ProMet Gold Herbicide
Study date
2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
296334
Title
4Farmers Prosulfocarb + S-Metolachlor - Barley
Study date
30-08-2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
296335
Title
4Farmers Prosulfocarb + S-Metolachlor - Wheat
Study date
30-08-2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
296336
Title
Post Emergent Boxer Gold EC Bio-equivalent
Study date
17-09-2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Date
Application Date
Application No
Application Number
150781
Product/Active constituent Name
Application Product Name
TITAN DIMETHOATE 400 SYSTEMIC INSECTICIDE
Application Date
Application Number
150781
Application Product Name
TITAN DIMETHOATE 400 SYSTEMIC INSECTICIDE
Application details
Product name:
TITAN DIMETHOATE 400 SYSTEMIC INSECTICIDE
Product number:
62511
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Variation of product registration to add an alternate formulation and formulation sites to registraion details
Reference details:
63470 - ACCENSI DIMETHOATE 400 SYSTEMIC INSECTICIDE
Active constituents:
Active constituent name
49020 - DIMETHOATE MANUFACTURING CONCENTRATE
Description of data provided:
Data no
296632
Title
Information from a letter of support from a third party
Study date
November 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
150791
Product/Active constituent Name
Application Product Name
Pymetrozine
Application Date
Application Number
150791
Application Product Name
Pymetrozine
Application details
Product name:
Pymetrozine
Active name:
Pymetrozine
Applicant Name:
SHANGHAI E-TONG CHEMICAL CO LTD
Application purpose and description of use:
Approval of Pymetrozine for use in agricultural chemical products.
Description of data provided:
Data no
296636
Title
Pymetrozine Declaration of Composition (DoC)
Study date
2025
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
296634
Title
Description Of Manufacturing Process Of Pymetrozine And Impurity Information
Study date
2025
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
296637
Title
Pymetrozine TGAI Certificates of Analysis and QA Support
Study date
2025
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
296638
Title
Pymetrozine SAFETY DATA SHEET
Study date
2025
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
296635
Title
Five Batches Analysis of Pymetrozine TGAI
Study date
2025
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Data no
296633
Title
Part 2 Pymetrozine Chemistry and Manufacturing
Study date
2025
Auth party contact address
3rd Floor, Building C3 Lane 6000 Shenzhuan Road, Songjiang District China
Date
Application Date
Application No
Application Number
150821
Product/Active constituent Name
Application Product Name
Agro-Essence Diuron 900 WG Herbicide
Application Date
Application Number
150821
Application Product Name
Agro-Essence Diuron 900 WG Herbicide
Application details
Product name:
Agro-Essence Diuron 900 WG Herbicide
Applicant Name:
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 900 g/kg Diuron water dispersible granule (WG) for the control of weeds in asparagus, bananas, cereals, cotton, lupins, sugar cane.
Date
Application Date
Application No
Application Number
151120
Product/Active constituent Name
Application Product Name
PROTECH BRONCHI-SHIELD ORAL BORDETELLA BRONCHISEPTICA LIVE VACCINE
Application Date
Application Number
151120
Application Product Name
PROTECH BRONCHI-SHIELD ORAL BORDETELLA BRONCHISEPTICA LIVE VACCINE
Application details
Product name:
PROTECH BRONCHI-SHIELD ORAL BORDETELLA BRONCHISEPTICA LIVE VACCINE
Product number:
70050
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Variation of product registration to remove non-standard conditions applied to the product.
Active constituents:
Active constituent name
83715 - BORDETELLA BRONCHISEPTICA
Description of data provided:
Data no
296097
Title
batch 5245044
Study date
16/07/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296098
Title
batch 5245044 part 2
Study date
16/07/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296099
Title
batch 5245044 part 3
Study date
16/07/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296100
Title
diluent 10J63S
Study date
08/03/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296101
Title
batch 5245045
Study date
19/11/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296102
Title
diluent batch 10J76
Study date
16/04/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296103
Title
batch 5245046
Study date
24/09/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296104
Title
batch 5245046 - part 2
Study date
24/09/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296105
Title
batch 5245046 - part 3
Study date
24/09/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296106
Title
Stability report
Study date
30/01/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296107
Title
Antigen stability
Study date
01/06/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296108
Title
PAA 139907 written advice
Study date
04/07/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296109
Title
import permit
Study date
27/08/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296110
Title
Executive summary Protech Bronchi-Shield Oral
Study date
20/11/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
306718
Title
batch 10J95S
Study date
24/05/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date
Application Date
Application No
Application Number
151131
Product/Active constituent Name
Application Product Name
PROTECH MULTI C3 CANINE DISTEMPER, ADENOVIRUS & PARVOVIRUS LIVE VACCINE
Application Date
Application Number
151131
Application Product Name
PROTECH MULTI C3 CANINE DISTEMPER, ADENOVIRUS & PARVOVIRUS LIVE VACCINE
Application details
Product name:
PROTECH MULTI C3 CANINE DISTEMPER, ADENOVIRUS & PARVOVIRUS LIVE VACCINE
Product number:
59730
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Variation of product registration to remove non-standard conditions applied to the registration.
Active constituents:
Active constituent name
54985 - CANINE DISTEMPER VIRUS
Active constituent name
57265 - HEPATITIS CANINE = CANINE ADENOVIRUS
Active constituent name
57473 - PARVOVIRUS - LIVE
Active constituent name
83690 - CANINE PARVOVIRUS
Active constituent name
83717 - CANINE ADENOVIRUS TYPE 2
Active constituent name
83718 - CANINE DISTEMPER VIRUS
Active constituent name
54985 - CANINE DISTEMPER VIRUS
Active constituent name
57265 - HEPATITIS CANINE = CANINE ADENOVIRUS
Active constituent name
57473 - PARVOVIRUS - LIVE
Description of data provided:
Data no
296149
Title
Batch 5262011
Study date
05/02/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296150
Title
Batch 5262012
Study date
20/07/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296151
Title
Stability report
Study date
28/02/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296152
Title
antigen stability
Study date
01/06/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296153
Title
PAA 139907 written advice
Study date
04/07/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296154
Title
antigen batch CAV3203THV 012
Study date
12/08/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296155
Title
CDV3166THV specification
Study date
22/09/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296156
Title
import permit
Study date
12/11/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
296157
Title
Executive summary Duramune C3
Study date
20/11/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
306717
Title
s159 response
Study date
08/05/2026
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
307560
Title
Outline of Production 1331.22
Study date
18/10/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
307561
Title
Veterinary medicines final technical report 124356
Study date
05/03/2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
307562
Title
Protech Multi C3 response to s159 notice
Study date
25/06/2026
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
311270
Title
351-PRC-001490 Titration and Identity of CDV in seed, harvest and final product
Study date
17/07/2019
Data no
311271
Title
351-PRC-001480 Ttitration and Identity of CAV in Seed, Harveset and Final Product
Study date
28/03/2019
Data no
311272
Title
351-PRC-0001485 Titration and Identity of CPV in Seed, Harvest and Final Product
Study date
21/12/2018
Data no
311273
Title
Special Outline 3156 Cainine distemper virus titration
Study date
29/03/2019
Data no
311274
Title
Special Outline 3157 Titration of canine parvovirus
Study date
17/04/2019
Data no
311275
Title
Special Outline 3158 Canine adenovirus titration
Study date
11/04/2019
Date
Application Date
Application No
Application Number
151193
Product/Active constituent Name
Application Product Name
Piperonyl Butoxide
Application Date
Application Number
151193
Application Product Name
Piperonyl Butoxide
Application details
Product name:
Piperonyl Butoxide
Active name:
Piperonyl Butoxide
Applicant Name:
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
Application purpose and description of use:
Approval of Piperonyl Butoxide for use in veterinary chemical products.
Description of data provided:
Data no
296225
Title
Certificates of analysis
Study date
14/10/2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
296226
Title
DMF 1
Study date
11/2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
296227
Title
DMF 2
Study date
11/2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Date
Application Date
Application No
Application Number
150474
Product/Active constituent Name
Application Product Name
Tulathromycin
Application Date
Application Number
150474
Application Product Name
Tulathromycin
Application details
Product name:
Tulathromycin
Active name:
Tulathromycin
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of a new source of active for use in veterinary chemical products.
Description of data provided:
Data no
293111
Title
Certificate of analysis
Study date
12 June 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
293112
Title
Specification
Study date
9 May 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296614
Title
Analytical Procedures
Study date
Nov 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296615
Title
General Test Method
Study date
5 Aug 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296616
Title
General Test Method
Study date
5 Aug 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296617
Title
Validation report of water content in Tulathromycin by
coulometric Karl Fischer
coulometric Karl Fischer
Study date
16 May 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296618
Title
Validation of Analytical Procedures
Study date
Nov 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296619
Title
Final Report for the Method Validation
Study date
6 March 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296620
Title
Compendial Verification Report
Study date
14 Nov 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296621
Title
Compendial Verification Report
Study date
08 Jan 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296622
Title
Compendial Test Methods for Specific Rotation analysis
Study date
18 Dec 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296623
Title
Compendial Test Method for Residue on Ignition analysis
Study date
15 Nov 2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296624
Title
Comparative Transfer Protocol for the Rathdrum Site Assay and Impurities Test Method
Study date
06 Aug 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296625
Title
Declaration
Study date
11 Jun 2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296626
Title
Regulatory Process Description
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
296627
Title
Description of Manufacturing Process and Process Controls
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date
Application Date
Application No
Application Number
150976
Product/Active constituent Name
Application Product Name
Randlab Dex 2mg/mL Injection
Application Date
Application Number
150976
Application Product Name
Randlab Dex 2mg/mL Injection
Application details
Product name:
Randlab Dex 2mg/mL Injection
Product number:
96860
Applicant Name:
RANDLAB AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a Dexamethasone 2mg/ml Injection (as sodium phosphate) for dogs, cats, horses, cattle, foals, calves and pigs.
Reference details:
87297 - Dexamethasone Sodium Phosphate
89900 - Randlab Dex 5 mg/mL Injection
52298 - DEXADRESON INJECTION
Date
Application Date
Application No
Application Number
150353
Product/Active constituent Name
Application Product Name
HASTEN SPRAY ADJUVANT
Application Date
Application Number
150353
Application Product Name
HASTEN SPRAY ADJUVANT
Application details
Product name:
HASTEN SPRAY ADJUVANT
Product number:
47999
Applicant Name:
VICTORIAN CHEMICAL COMPANY PROPRIETARY LIMITED
Application purpose and description of use:
Variation of product label approval to expand the list of supported Hasten use-patterns with tank mixture partner products (herbicides, insecticides and fungicides).
Reference details:
60114 - ADIGOR SPRAY ADJUVANT
66684 - BENEVIA INSECTICIDE
66684 - DUPONT BENEVIA INSECTICIDE
68451 - BANJO SPRAY ADJUVANT
83320 - TITAN DUELLING SPRAY ADJUVANT
89948 - TENET 500 SC HERBICIDE
91200 - Sipcam Aggressor Herbicide
91459 - SIERRA HERBICIDE
91984 - Infinity Ultra Herbicide
92030 - Pylex Herbicide
92937 - Radial Opti Fungicide
Active constituents:
Active constituent name
60438 - METHYL ESTERS OF CANOLA OIL FATTY ACIDS
Active constituent name
60725 - ETHYL ESTERS OF CANOLA OIL FATTY ACIDS
Description of data provided:
Data no
294544
Title
HASTEN LABEL CROSSWALK - LABEL VARIATION 24092025
Study date
24 September 2025
Auth party contact address
83 MAFFRA ST COOLAROO Australia
Data no
294545
Title
HASTEN Directions for Use
Study date
24 September 2025
Auth party contact address
83 MAFFRA ST COOLAROO Australia
Data no
294546
Title
HASTEN General Instructions
Study date
24 September 2025
Auth party contact address
83 MAFFRA ST COOLAROO Australia
Data no
294547
Title
18501 Hasten Spray Adjuvant
Study date
24 September 2025
Auth party contact address
83 MAFFRA ST COOLAROO Australia
Data no
295397
Title
Consent for Use of Information with Limitation of Use - Hasten Spray Adjuvant
Study date
24 September 2025
Auth party contact address
Protected Data Owner
Data no
295398
Title
Letter of support for Victorian Chemical Company Proprietary Limited
Study date
1 October 2025
Auth party contact address
Protected Data Owner
Data no
295399
Title
Consent for Use of Information with Limitation of Use - Hasten Spray Adjuvant
Study date
23 September 2025
Auth party contact address
Protected Data Owner
Data no
295651
Title
Letter of consent to access protected data and information
Study date
31 October 2025
Auth party contact address
Data owner
Data no
295652
Title
Consent to Use of Cyantraniliprole Protected Information for Victorian Chemical Company Proprietary Limited for Hasten Spray Adjuvant
Study date
31 October 2025
Auth party contact address
Data Owner
Date
Application Date
Application No
Application Number
150397
Product/Active constituent Name
Application Product Name
MAROPITANT 10 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS
Application Date
Application Number
150397
Application Product Name
MAROPITANT 10 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS
Application details
Product name:
MAROPITANT 10 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS
Product number:
96684
Applicant Name:
INTAS PHARMACEUTICALS LIMITED
Application purpose and description of use:
Registration of a 10 mg/mL maropitant (as citrate) injectable product for the prevention or treatment of vomiting or nausea in cats and dogs.
Reference details:
61840 - CERENIA INJECTABLE SOLUTION
Active constituents:
Active constituent name
96685 - Maropitant citrate
Description of data provided:
Data no
292931
Title
Product specifications
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
292932
Title
Certificate
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
292933
Title
Certificate
Study date
2024
Auth party contact address
-
Data no
294763
Title
GMP Report
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
295821
Title
GMP Certificate
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Date
Application Date
Application No
Application Number
150398
Product/Active constituent Name
Application Product Name
Maropitant citrate
Application Date
Application Number
150398
Application Product Name
Maropitant citrate
Application details
Product name:
Maropitant citrate
Active name:
Maropitant citrate
Applicant Name:
INTAS PHARMACEUTICALS LIMITED
Application purpose and description of use:
New source of active constituent.
Description of data provided:
Data no
294346
Title
Certificates of analysis
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
294347
Title
DMF 32s0
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
294348
Title
DMF 32s1
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
294349
Title
DMF 32s2
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
294350
Title
DMF 32s3
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
294351
Title
DMF 32s4
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
294352
Title
DMF 32s5
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
294353
Title
DMF 32s6
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
294354
Title
DMF 32s7
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Date
Application Date
Application No
Application Number
150635
Product/Active constituent Name
Application Product Name
GENFARM BIXAFEN-PRO 225 EC FUNGICIDE
Application Date
Application Number
150635
Application Product Name
GENFARM BIXAFEN-PRO 225 EC FUNGICIDE
Application details
Product name:
GENFARM BIXAFEN-PRO 225 EC FUNGICIDE
Product number:
96772
Applicant Name:
NUTRIEN AG SOLUTIONS LIMITED
Application purpose and description of use:
Registration of a emulsifiable concentrate fungicide containing 150 g/L prothioconazole and 75 g/L of bixafen for the control of various diseases in canola, barley, wheat, chickpeas, faba beans, field peas and lentils.
Reference details:
69361 - AVIATOR XPRO FOLIAR FUNGICIDE
Active constituents:
Active constituent name
95253 - BIXAFEN
Active constituent name
92211 - Thiamethoxam
Active constituent name
85487 - Prothioconazole
Description of data provided:
Data no
295675
Title
Certificate of Analysis
Study date
15-Oct-2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
295676
Title
Safety Data Sheets
Study date
15-Feb-2022
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
295677
Title
Product Stability of Genfarm Bixafen-Pro 225 EC Fungicide
Study date
5-Mar-2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
295678
Title
Method Validation of Genfarm Bixafen-Pro 225 EC Fungicide
Study date
5-Mar-2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
295679
Title
Manufacturing Process for Genfarm Bixafen-Pro 225 EC Fungicide
Study date
5-Mar-2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
295680
Title
Chemistry & Manufacture Part 2 for Genfarm Bixafen-Pro 225 EC Fungicide
Study date
09-Oct-2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
295681
Title
Crop safety and efficacy evaluation of Genfarm Bixafen-Pro 225 EC Fungicide for control of disease in Canola (Brassica napus) cv. DG Avon TT
Study date
2-May-25
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
295682
Title
Crop safety and efficacy evaluation of Genfarm Bixafen-Prothio 225 EC for control of disease in Canola (Brassica napus) cv. Trifecta TT
Study date
2-May-25
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
295683
Title
Crop safety and efficacy evaluation of Genfarm Bixafen-Pro 225 EC Fungicide for control of disease in Canola (Brassica napus) cv. PY525 G
Study date
2-May-25
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
295684
Title
Crop safety and efficacy evaluation of Genfarm Bixafen-Pro 225 EC Fungicide for control of disease in Faba beans (Vicia Faba) cv. PBA Bendoc
Study date
2-May-25
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
295685
Title
Crop safety and efficacy evaluation of Genfarm Bixafen-Pro 225 EC Fungicide for control of disease in Lentil (Vicia lens) cv. ALB Terrier
Study date
2-May-25
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
295686
Title
Crop safety and efficacy evaluation of Genfarm Bixafen-Pro 225 EC Fungicide for control of disease in Wheat (Triticum aestivum) cv. Beckom
Study date
2-May-25
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
295687
Title
Crop safety and efficacy evaluation of Genfarm Bixafen-Pro 225 EC Fungicide for control of disease in Wheat (Triticum aestivum) cv. Beckom
Study date
2-May-25
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
295688
Title
Crop safety and efficacy evaluation of Genfarm Bixafen-Prothio 225 EC for control of disease in Barley (Hordeum vulgare) cv. Spinnaker
Study date
2-May-25
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
295689
Title
Crop Safety & Efficacy Part 8 for Genfarm Bixafen-Pro 225 EC Fungicide
Study date
08-Oct-2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
295690
Title
Executive Summary for Genfarm Bixafen-Pro 225 EC Fungicide
Study date
17-Oct-2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
150787
Product/Active constituent Name
Application Product Name
Pirimiphos-Methyl
Application Date
Application Number
150787
Application Product Name
Pirimiphos-Methyl
Application details
Product name:
Pirimiphos-Methyl
Active name:
Pirimiphos-Methyl
Applicant Name:
HUNAN HAILI CHEMICAL INDUSTRY CO., LTD
Application purpose and description of use:
Approval of Pirimiphos-Methyl technical-grade material for use in agricultural chemical products.
Description of data provided:
Data no
296552
Title
Pirimiphos methyl, Technical Grade Manufacture Process
Study date
11/2025
Auth party contact address
#251, 2nd Section Furong Road (M) Changsha, Hunan People's Republic of China
Data no
296553
Title
Five-Batch Analysis of Pirimiphos-methyl Technical (Active Ingredient)
Study date
17/10/2025
Auth party contact address
#251, 2nd Section Furong Road (M) Changsha, Hunan People's Republic of China
Data no
296554
Title
Five-Batch Analysis of Pirimiphos-methyl Technical (Impurities)
Study date
17/10/2025
Auth party contact address
#251, 2nd Section Furong Road (M) Changsha, Hunan People's Republic of China
Data no
296555
Title
Pirimiphos methyl, Impurities Justification
Study date
11/2025
Auth party contact address
#251, 2nd Section Furong Road (M) Changsha, Hunan People's Republic of China
Data no
296556
Title
Declaration of composition
Study date
25/06/2025
Auth party contact address
#251, 2nd Section Furong Road (M) Changsha, Hunan People's Republic of China
Date
Application Date
Application No
Application Number
150692
Product/Active constituent Name
Application Product Name
Tebuthiuron
Application Date
Application Number
150692
Application Product Name
Tebuthiuron
Application details
Product name:
Tebuthiuron
Active name:
Tebuthiuron
Applicant Name:
JIANGXI ZHONGHE BIOTECHNOLOGY CO., LTD.
Application purpose and description of use:
Approval of Tebuthiuron for use in agricultural chemical products.
Date
Application Date
Application No
Application Number
150777
Product/Active constituent Name
Application Product Name
Prometryn
Application Date
Application Number
150777
Application Product Name
Prometryn
Application details
Product name:
Prometryn
Active name:
Prometryn
Applicant Name:
Hebei Shanli Chemical Company Limited
Application purpose and description of use:
Approval of prometryn for use in agricultural chemical products.
Description of data provided:
Data no
296342
Title
Prometryn MATERIAL SAFETY DATA SHEET
Study date
2025
Auth party contact address
No. 2 Tianjin Road, Cangzhou Lingang Economic & Technological Development Zone, Bohai New Area Cangzhou City People's Republic of China
Data no
296339
Title
Determination of the test substance Prometryn (Five Batch Analysis)
Study date
2025
Auth party contact address
No. 2 Tianjin Road, Cangzhou Lingang Economic & Technological Development Zone, Bohai New Area Cangzhou City People's Republic of China
Data no
308047
Title
Response to Regulatory Queries Regarding Prometryn Technical
Study date
2026
Auth party contact address
No. 2 Tianjin Road, Cangzhou Lingang Economic & Technological Development Zone, Bohai New Area Cangzhou City People's Republic of China
Data no
296340
Title
Declaration of Composition (DoC) of Prometryn
Study date
2025
Auth party contact address
No. 2 Tianjin Road, Cangzhou Lingang Economic & Technological Development Zone, Bohai New Area Cangzhou City People's Republic of China
Data no
296337
Title
Chemistry and Manufacture
Study date
2025
Auth party contact address
No. 2 Tianjin Road, Cangzhou Lingang Economic & Technological Development Zone, Bohai New Area Cangzhou City People's Republic of China
Data no
296338
Title
Synthesis and Impurities of Prometryn Technical
Study date
2025
Auth party contact address
No. 2 Tianjin Road, Cangzhou Lingang Economic & Technological Development Zone, Bohai New Area Cangzhou City People's Republic of China
Data no
296341
Title
Certificates of Analysis (COA) and Manufacturer Declaration of Prometryn
Study date
2025
Auth party contact address
No. 2 Tianjin Road, Cangzhou Lingang Economic & Technological Development Zone, Bohai New Area Cangzhou City People's Republic of China
Date
Application Date
Application No
Application Number
150778
Product/Active constituent Name
Application Product Name
Terbutryn
Application Date
Application Number
150778
Application Product Name
Terbutryn
Application details
Product name:
Terbutryn
Active name:
Terbutryn
Applicant Name:
Hebei Shanli Chemical Company Limited
Application purpose and description of use:
Approval of terbutryn for use in agricultural chemical products.
Description of data provided:
Data no
296350
Title
Chemistry and Manufacture of Terbutryn
Study date
2025
Auth party contact address
No. 2 Tianjin Road, Cangzhou Lingang Economic & Technological Development Zone, Bohai New Area Cangzhou City People's Republic of China
Data no
296353
Title
Declaration of Composition (DoC) of Terbutryn
Study date
2025
Auth party contact address
No. 2 Tianjin Road, Cangzhou Lingang Economic & Technological Development Zone, Bohai New Area Cangzhou City People's Republic of China
Data no
296351
Title
Synthesis and Impurities of Terbutryn Technical
Study date
2025
Auth party contact address
No. 2 Tianjin Road, Cangzhou Lingang Economic & Technological Development Zone, Bohai New Area Cangzhou City People's Republic of China
Data no
296354
Title
Certificates of Analysis and Manufacturer Declaration of Terbutryn
Study date
2025
Auth party contact address
No. 2 Tianjin Road, Cangzhou Lingang Economic & Technological Development Zone, Bohai New Area Cangzhou City People's Republic of China
Data no
296352
Title
Determination of Active Content and Impurity Profile of Terbutryn (Five Batch Analysis)
Study date
2025
Auth party contact address
No. 2 Tianjin Road, Cangzhou Lingang Economic & Technological Development Zone, Bohai New Area Cangzhou City People's Republic of China
Data no
296355
Title
Terbutryn MATERIAL SAFETY DATA SHEET
Study date
2025
Auth party contact address
No. 2 Tianjin Road, Cangzhou Lingang Economic & Technological Development Zone, Bohai New Area Cangzhou City People's Republic of China
Date
Application Date
Application No
Application Number
150783
Product/Active constituent Name
Application Product Name
Fludioxonil
Application Date
Application Number
150783
Application Product Name
Fludioxonil
Application details
Product name:
Fludioxonil
Active name:
Fludioxonil
Applicant Name:
VISION FLUOROCHEM (NANJING) LTD.
Application purpose and description of use:
Approval of fludioxonil for use in agricultural chemical products.
Description of data provided:
Data no
296388
Title
Chemistry and Manufacture
Study date
2025
Auth party contact address
150 Puqiao Rd Nanjing Chemical Industry Park Nanjing China
Data no
296389
Title
Synthesis and Impurities of Fludioxonil Technical
Study date
2025
Auth party contact address
150 Puqiao Rd Nanjing Chemical Industry Park Nanjing China
Data no
296390
Title
Qualitative and Quantitative Profile of the test substance Fludioxonil (Five Batch Analysis)
Study date
2025
Auth party contact address
150 Puqiao Rd Nanjing Chemical Industry Park Nanjing China
Data no
296391
Title
Declaration of Composition (DoC) of Fludioxonil Technical
Study date
2025
Auth party contact address
150 Puqiao Rd Nanjing Chemical Industry Park Nanjing China
Data no
296392
Title
Certificates of Analysis (COA) and Statement of Batches of Fludioxonil Technical
Study date
2025
Auth party contact address
150 Puqiao Rd Nanjing Chemical Industry Park Nanjing China
Data no
296393
Title
Fludioxonil Safety Data Sheet
Study date
2025
Auth party contact address
150 Puqiao Rd Nanjing Chemical Industry Park Nanjing China
Data no
311791
Title
Determination of NMR of Fludioxonil Technical
Study date
2026
Auth party contact address
150 Puqiao Rd Nanjing Chemical Industry Park Nanjing China
Data no
311792
Title
Formal method consistency statement for the inspection and verification by the Australian Pesticides and Veterinary Medicines Authority
Study date
2026
Auth party contact address
150 Puqiao Rd Nanjing Chemical Industry Park Nanjing China
Data no
311793
Title
S159 Response letter
Study date
2026
Auth party contact address
150 Puqiao Rd Nanjing Chemical Industry Park Nanjing China
Date
Application Date
Application No
Application Number
150729
Product/Active constituent Name
Application Product Name
Quantum ProTeb 420 EC Fungicide
Application Date
Application Number
150729
Application Product Name
Quantum ProTeb 420 EC Fungicide
Application details
Product name:
Quantum ProTeb 420 EC Fungicide
Product number:
92354
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Variation of product registration Quantum ProTeb 420 EC Herbicide (APVMA No.92354) and label approval to add
a new pack size range (1-1000L) and packaging material (HDPE level 3 fluorinated)
Active constituents:
Active constituent name
86315 - Prothioconazole
Active constituent name
82912 - Tebuconazole