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

154649
Product/Active constituent Name

Application Product Name

F.S.A. Vixin Herbicide

Application details

Product name:

F.S.A. Vixin Herbicide

Applicant Name:

FOUR SEASONS AGRIBUSINESS PTY LTD

Application purpose and description of use:

The aim of this application is to apply for a soluble concentrate formulation of 33 g/L IMAZAMOX present as the ammonium salt and 15 g/L IMAZAPYR present as the ammonium salt for the early post-emergence control of certain annual grass and broadleaf weeds as part of the Clearfield® Production System for Clearfield Plus wheat, Clearfield barley, and Clearfield canola.
Date

Application Date

Application No

Application Number

152680
Product/Active constituent Name

Application Product Name

CLAVOX L BROAD SPECTRUM ANTIBIOTIC TABLETS

Application details

Product name:

CLAVOX L BROAD SPECTRUM ANTIBIOTIC TABLETS

Product number:

92071

Applicant Name:

ABBEY LABORATORIES PTY LTD

Application purpose and description of use:

The purpose of this application is to do the variation to the registered product Clavox L Broad Spectrum Antibiotic Tablets.

Active constituents:

Active constituent name
84057 - AMOXICILLIN TRIHYDRATE
Active constituent name
91895 - Clavulanate Potassium-Microcrystalline cellulose (1:1)

Description of data provided:

Data no
303755
Author
DAFF
Title
AQIS Permit
Study date
2023
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
303593
Author
Abbeylabs
Title
Product specifications
Study date
2026
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
303594
Author
Abbeylabs
Title
Executive summary
Study date
2026
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Date

Application Date

Application No

Application Number

154061
Product/Active constituent Name

Application Product Name

SEAJET 034 EMPEROR BRIGHT RED

Application details

Product name:

SEAJET 034 EMPEROR BRIGHT RED

Applicant Name:

Chugoku Paints B.V.

Application purpose and description of use:

Registration of SEAJET 034 EMPEROR BRIGHT RED with 30 w/w% Cuprous Thiocyanate and 3 w/w% Zinc Pyrithione antifouling paint.
Date

Application Date

Application No

Application Number

154149
Product/Active constituent Name

Application Product Name

SEAJET 039 PLATINUM 2-COMPONENTS – Component A BLACK

Application details

Product name:

SEAJET 039 PLATINUM 2-COMPONENTS – Component A BLACK

Applicant Name:

Chugoku Paints B.V.

Application purpose and description of use:

Registration of SEAJET 039 PLATINUM 2-COMPONENTS – Component A BLACK antifouling paint, as part of a 2 component system, containing 4,833 w/w% Zinc Pyrithione.
Date

Application Date

Application No

Application Number

154155
Product/Active constituent Name

Application Product Name

SEAJET 032 PROFESSIONAL BLUE

Application details

Product name:

SEAJET 032 PROFESSIONAL BLUE

Applicant Name:

Chugoku Paints B.V.

Application purpose and description of use:

Registration SEAJET 032 PROFESSIONAL BLUE with 30 w/w% Cuprous Oxide antifouling paint
Date

Application Date

Application No

Application Number

154157
Product/Active constituent Name

Application Product Name

SEAJET 032 PROFESSIONAL RED

Application details

Product name:

SEAJET 032 PROFESSIONAL RED

Applicant Name:

Chugoku Paints B.V.

Application purpose and description of use:

Registration SEAJET 032 PROFESSIONAL RED with 30 w/w% Cuprous Oxide antifouling paint
Date

Application Date

Application No

Application Number

154158
Product/Active constituent Name

Application Product Name

SEAJET 032 PROFESSIONAL BLACK

Application details

Product name:

SEAJET 032 PROFESSIONAL BLACK

Applicant Name:

Chugoku Paints B.V.

Application purpose and description of use:

Registration SEAJET 032 PROFESSIONAL BLACK with 30 w/w% Cuprous Oxide antifouling paint
Date

Application Date

Application No

Application Number

154224
Product/Active constituent Name

Application Product Name

SEAJET 039 PLATINUM 2-COMPONENTS – Component B

Application details

Product name:

SEAJET 039 PLATINUM 2-COMPONENTS – Component B

Applicant Name:

Chugoku Paints B.V.

Application purpose and description of use:

Registration of SEAJET 039 PLATINUM 2-COMPONENTS – Component B antifouling paint, as part of a 2 component system, containing 100 w/w% Cuprous Oxide.
Date

Application Date

Application No

Application Number

154269
Product/Active constituent Name

Application Product Name

SEAJET 039 PLATINUM 2-COMPONENTS – Component A RED

Application details

Product name:

SEAJET 039 PLATINUM 2-COMPONENTS – Component A RED

Applicant Name:

Chugoku Paints B.V.

Application purpose and description of use:

Registration of SEAJET 039 PLATINUM 2-COMPONENTS – Component A RED antifouling paint, as part of a 2 component system, containing 4,833 w/w% Zinc Pyrithione.
Date

Application Date

Application No

Application Number

154273
Product/Active constituent Name

Application Product Name

SEAJET 039 PLATINUM 2-COMPONENTS – Component A MID BLUE

Application details

Product name:

SEAJET 039 PLATINUM 2-COMPONENTS – Component A MID BLUE

Applicant Name:

Chugoku Paints B.V.

Application purpose and description of use:

Registration of SEAJET 039 PLATINUM 2-COMPONENTS – Component A MID BLUE antifouling paint, as part of a 2 component system, containing 4,833 w/w% Zinc Pyrithione.
Date

Application Date

Application No

Application Number

154351
Product/Active constituent Name

Application Product Name

praziquantel

Application details

Product name:

praziquantel

Active name:

praziquantel

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Approval of praziquantel for use in veterinary chemical products.

Description of data provided:

Data no
307717
Author
European Directorate for the Quality of Medicines and Healthcare
Title
Certificate of suitability, praziquantel
Study date
2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
307231
Author
Anon
Title
3 x COA
Study date
April 2026
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
307232
Author
Anon
Title
Praziquantel EP monograph
Study date
2026
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

154608
Product/Active constituent Name

Application Product Name

CYTOPOINT Solution for Injection for Dogs 20 mg

Application details

Product name:

CYTOPOINT Solution for Injection for Dogs 20 mg

Product number:

83541

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration to update the non-standard condition.

Active constituents:

Active constituent name
83537 - LOKIVETMAB

Description of data provided:

Data no
307740
Author
EMA
Title
Rapporteur???s variation assessment report - Standard 60-day
Study date
12 June 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
307737
Author
Anon
Title
Variation Summary document
Study date
March 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
307746
Author
EMA
Title
List of questions for a variation requiring assessment for Cytopoint
Study date
12 June 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
307743
Author
Zoetis Inc
Title
Batch record
Study date
10 July 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
307738
Author
Zoetis Inc
Title
Microbial limits membrane filteration validation method
Study date
7 Aug 24
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
307744
Author
Zoetis Inc
Title
Batch record
Study date
10 July 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
307741
Author
Zoetis Inc
Title
Opinion of the Committee for Veterinary Medicinal Products on a group of variations requiring assessment to the terms of the marketing authorisation
Study date
10 September 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
307745
Author
Zoetis Inc
Title
ACTIVE SUBSTANCE REGULATORY STABILITY STUDY
Study date
20 Feb 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
307742
Author
Zoetis Inc
Title
Batch record
Study date
10 July 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
307739
Author
Zoetis Inc
Title
Active substance specification
Study date
17 Feb 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date

Application Date

Application No

Application Number

154064
Product/Active constituent Name

Application Product Name

AURIZON EAR DROPS

Application details

Product name:

AURIZON EAR DROPS

Product number:

67225

Applicant Name:

VETOQUINOL AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product label to align with the current ACVM-approved label and maintain AU/NZ label harmonisation.

Active constituents:

Active constituent name
83282 - Marbofloxacin
Active constituent name
83260 - Clotrimazole

Description of data provided:

Data no
306729
Author
ACVM
Title
A010031-12 - Approved Label - Feb 2026
Study date
2026
Authorising party
Applicant
Auth party contact address
Level 2 485 Kingsford Smith Drive Hamilton Australia
Date

Application Date

Application No

Application Number

154051
Product/Active constituent Name

Application Product Name

SEAJET 034 EMPEROR BLACK

Application details

Product name:

SEAJET 034 EMPEROR BLACK

Applicant Name:

Chugoku Paints B.V.

Application purpose and description of use:

Registration of SEAJET 034 EMPEROR BLACK with 30 w/w% Cuprous Thiocyanate and 3 w/w% Zinc Pyrithione antifouling paint.
Date

Application Date

Application No

Application Number

154053
Product/Active constituent Name

Application Product Name

SEAJET 034 EMPEROR WHITE

Application details

Product name:

SEAJET 034 EMPEROR WHITE

Applicant Name:

Chugoku Paints B.V.

Application purpose and description of use:

Registration of SEAJET 034 EMPEROR WHITE antifouling paint with 22.7% Cuprous Thiocyanate and 2.72% Zinc Pyrithione.
Date

Application Date

Application No

Application Number

154055
Product/Active constituent Name

Application Product Name

SEAJET 034 EMPEROR NAVY BLUE

Application details

Product name:

SEAJET 034 EMPEROR NAVY BLUE

Applicant Name:

Chugoku Paints B.V.

Application purpose and description of use:

Registration of SEAJET 034 EMPEROR NAVY BLUE with 30 w/w% Cuprous Thiocyanate and 3 w/w% Zinc Pyrithione antifouling paint.
Date

Application Date

Application No

Application Number

154147
Product/Active constituent Name

Application Product Name

SEAJET 039 PLATINUM 2-COMPONENTS – Component A NAVY BLUE

Application details

Product name:

SEAJET 039 PLATINUM 2-COMPONENTS – Component A NAVY BLUE

Applicant Name:

Chugoku Paints B.V.

Application purpose and description of use:

Registration of SEAJET 039 PLATINUM 2-COMPONENTS – Component A NAVY BLUE antifouling paint, as part of a 2 component system, containing 4,833 w/w% Zinc Pyrithione.
Date

Application Date

Application No

Application Number

154288
Product/Active constituent Name

Application Product Name

Accensi Iprodione 365 SE Fungicide A

Application details

Product name:

Accensi Iprodione 365 SE Fungicide A

Applicant Name:

AUSTRALIAN AGRIBUSINESS (HOLDINGS) PTY LTD

Application purpose and description of use:

Registration of a 365 g/L Iprodione suspo-emulsion formulation with improved rainfastness (over other water based formulations) for the control of fungal diseases in recreational turf as specified in the directions for use.
Date

Application Date

Application No

Application Number

154289
Product/Active constituent Name

Application Product Name

Accensi Iprodione 365 SE Fungicide B

Application details

Product name:

Accensi Iprodione 365 SE Fungicide B

Applicant Name:

AUSTRALIAN AGRIBUSINESS (HOLDINGS) PTY LTD

Application purpose and description of use:

Registration of a 365 g/L Iprodione suspoemulsion product for improved rainfastness (over other water based formulations) for the control of fungal diseases in recreational turf as specified in the directions for use.
Date

Application Date

Application No

Application Number

154324
Product/Active constituent Name

Application Product Name

Platinum Xtra 360 Herbicide - B

Application details

Product name:

Platinum Xtra 360 Herbicide - B

Applicant Name:

ADAMA AUSTRALIA PTY LIMITED

Application purpose and description of use:

Registration of a 360 g/L Clethodim EC product for proposed uses as mentioned in the directions for use table.