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

150761
Product/Active constituent Name

Application Product Name

Quantum Accelerate Spray Adjuvant

Application details

Product name:

Quantum Accelerate Spray Adjuvant

Applicant Name:

QUANTUM AGROSCIENCES HOLDINGS PTY LTD

Application purpose and description of use:

Registration of a 704 g/L METHYL AND ETHYL ESTERS OF FREE FATTY ACIDS DERIVED FRPM REFINED CANOLA OIL emulsifiable concentrate product, Biodegradable Penetrator Adjuvant to Enhance the Effectiveness of Certain Herbicides
Date

Application Date

Application No

Application Number

148901
Product/Active constituent Name

Application Product Name

Cloxacillin Benzathine

Application details

Product name:

Cloxacillin Benzathine

Active name:

Cloxacillin Benzathine

Applicant Name:

ABBEY LABORATORIES PTY LTD

Application purpose and description of use:

New source of pharmacopoeia active constituent

Description of data provided:

Data no
295815
Author
Abbey Laboratories Pty Ltd
Title
Active COA
Study date
June 2025
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
295816
Author
Abbey Laboratories Pty Ltd
Title
Active details
Study date
2025
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Date

Application Date

Application No

Application Number

150402
Product/Active constituent Name

Application Product Name

Gro-Sure Spray Adjuvant

Application details

Product name:

Gro-Sure Spray Adjuvant

Product number:

89976

Applicant Name:

AGRITRADING PTY LIMITED

Application purpose and description of use:

Variation of product registration and label approval to include 45000 L bulk pack
Date

Application Date

Application No

Application Number

150303
Product/Active constituent Name

Application Product Name

CropSure Isoxaflutole 750WG Herbicide

Application details

Product name:

CropSure Isoxaflutole 750WG Herbicide

Product number:

96655

Applicant Name:

CROPSURE PTY LTD

Application purpose and description of use:

Registration of a 750 g/kg ISOXAFLUTOLE, Water Dispersible Granule product for the control and suppression of various broadleaf weeds and grasses in sugarcane and chickpeas as specified in the Directions For Use Table..

Reference details:

88874 - JSAL ISOXAFLUTOLE 750 WG HERBICIDE
81222 - CONQUEST BOUNTY 750 WG HERBICIDE

Active constituents:

Active constituent name
69135 - ISOXAFLUTOLE
Date

Application Date

Application No

Application Number

150478
Product/Active constituent Name

Application Product Name

CropSure Fluroxypyr 400 Herbicide

Application details

Product name:

CropSure Fluroxypyr 400 Herbicide

Product number:

92589

Applicant Name:

CROPSURE PTY LTD

Application purpose and description of use:

Addition of formulation and active and manufacturing sites

Reference details:

86354 - Spalding Fluroxypyr 400 Herbicide

Active constituents:

Active constituent name
59089 - FLUROXYPYR-MEPTYL
Date

Application Date

Application No

Application Number

150708
Product/Active constituent Name

Application Product Name

NAMBDA 250 CS Insecticide

Application details

Product name:

NAMBDA 250 CS Insecticide

Product number:

96798

Applicant Name:

UNITED CROPSCIENCE PTE., LTD.

Application purpose and description of use:

Registration of a 250 g/L Lambda cyhalothrin capsule suspension product for the control of certain insect pests in Cotton, Barley, Wheat and various field crops as per the Directions for Use

Reference details:

67072 - EASYFARM LAMBDA 250 CS INSECTICIDE

Active constituents:

Active constituent name
55867 - LAMBDA-CYHALOTHRIN
Date

Application Date

Application No

Application Number

150709
Product/Active constituent Name

Application Product Name

NAXILAR Growth Regulator

Application details

Product name:

NAXILAR Growth Regulator

Product number:

96799

Applicant Name:

UNITED CROPSCIENCE PTE., LTD.

Application purpose and description of use:

Registration of a 200g/kg gibberellic acid water soluble granule product for foliar spray application to certain varieties of Grapes, Citrus and Prunes to promote desirable harvest effects.

Reference details:

87303 - F.S.A. Gibberellic Acid Growth Regulant

Active constituents:

Active constituent name
52731 - GIBBERELLIC ACID
Date

Application Date

Application No

Application Number

150773
Product/Active constituent Name

Application Product Name

Spectinomycin sulfate

Application details

Product name:

Spectinomycin sulfate

Active name:

Spectinomycin sulfate

Applicant Name:

PHIBRO ANIMAL HEALTH PTY LIMITED

Application purpose and description of use:

Approval of spectinomycin sulfate for use in veterinary chemical products.

Description of data provided:

Data no
295366
Author
Not Identified
Title
Certificates of analysis
Study date
2025
Authorising party
Applicant
Auth party contact address
Suite 416 / 14-16 Lexington Drive Bella Vista Australia
Data no
295367
Author
Not Identified
Title
Monograph
Study date
2022
Authorising party
Applicant
Auth party contact address
Suite 416 / 14-16 Lexington Drive Bella Vista Australia
Date

Application Date

Application No

Application Number

150774
Product/Active constituent Name

Application Product Name

Spectinomycin sulfate

Application details

Product name:

Spectinomycin sulfate

Active name:

Spectinomycin sulfate

Applicant Name:

PHIBRO ANIMAL HEALTH PTY LIMITED

Application purpose and description of use:

Approval of spectinomycin sulfate for use in veterinary chemical products.

Description of data provided:

Data no
295368
Author
Not Identified
Title
Certificates of analysis
Study date
2025
Authorising party
Applicant
Auth party contact address
Suite 416 / 14-16 Lexington Drive Bella Vista Australia
Data no
295369
Author
Not Identified
Title
Monograph
Study date
2022
Authorising party
Applicant
Auth party contact address
Suite 416 / 14-16 Lexington Drive Bella Vista Australia
Data no
295370
Author
Not Identified
Title
Certificate
Study date
2022
Authorising party
Applicant
Auth party contact address
Suite 416 / 14-16 Lexington Drive Bella Vista Australia
Date

Application Date

Application No

Application Number

150411
Product/Active constituent Name

Application Product Name

Avilive Fluroxpyr 400EC Herbicide

Application details

Product name:

Avilive Fluroxpyr 400EC Herbicide

Product number:

96686

Applicant Name:

Zhejiang Avilive Chemical Imp. & Exp. Co., Ltd.

Application purpose and description of use:

Registration of a 400 g/l emulsifiable concentrate present as the FLUROXYPYR AS THE METHYL HEPTYL ESTER product for the Control of a Wide Range of Broadleaf Weeds in Fallow, Lucerne, Maize, Millets, Pastures, Sorghum, Sugar Cane, Sweet Corn, Winter Cereals. Also for the Control of Woody Weeds in Agricultural Non-Crop Areas, Commercial and Industrial Areas, Pastures and Rights-of-Way as Specified in the Directions for Use .

Reference details:

83865 - EUREKA! Fluroxypyr 400 Herbicide
89664 - Farmalinx Swysh 400 EC Herbicide

Active constituents:

Active constituent name
94847 - Fluroxypyr meptyl
Active constituent name
59455 - FLUROXYPYR-MEPTYL
Date

Application Date

Application No

Application Number

149886
Product/Active constituent Name

Application Product Name

CEFOVECIN SODIUM MICRONISED

Application details

Product name:

CEFOVECIN SODIUM MICRONISED

Active name:

CEFOVECIN SODIUM MICRONISED

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

New source of active constituent
Date

Application Date

Application No

Application Number

149885
Product/Active constituent Name

Application Product Name

Convenia RTU for Dogs

Application details

Product name:

Convenia RTU for Dogs

Product number:

96566

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 160 mg/mL cefovecin Ready-to-Use Injectable suspension for dogs.

Active constituents:

Active constituent name
96567 - CEFOVECIN SODIUM MICRONISED

Description of data provided:

Data no
291201
Author
Not Identified
Title
GMP certificate
Study date
July 30, 2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291202
Author
Not Identified
Title
Audit Report
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291200
Author
Zoetis Australia Pty Ltd
Title
Part 1 Overview
Study date
August 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291204
Author
Zoetis Australia Pty Ltd
Title
Part 2 Summary
Study date
August 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291205
Author
Not Identified
Title
Chemistry Manufacturing and Control Initial Technical Section
Study date
March 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291206
Author
Zoetis Australia Pty Ltd
Title
Part 8 Summary
Study date
August 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291212
Author
Derek Conti
Title
Bioequivalence study
Study date
11 Oct 2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291207
Author
Not Identified
Title
Effectiveness Technical Section
Study date
August 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291208
Author
Not Identified
Title
Target Animal Safety Technical Section
Study date
August 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291209
Author
Ann E. Fielder
Title
Method validation
Study date
21 July 2023
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291210
Author
Ann E. Fielder
Title
Method validation amendment
Study date
21 July 2023
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291211
Author
Natalie Bissland
Title
Partial Method Validation
Study date
12 Nov 2015
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291214
Author
Zoetis
Title
Convenia Safety and Efficacy Review
Study date
11 Oct 2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291215
Author
Zoetis
Title
Periodic Safety Update Report
Study date
21 February 2023
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291213
Author
Zoetis
Title
Safety study
Study date
August 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291203
Author
Not Identified
Title
Summary
Study date
August 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291216
Author
Zoetis Australia Pty Ltd
Title
Part 10 Justification
Study date
August 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
291217
Author
Rynhoud et al.
Title
Epidemiology of methicillin resistant Staphylococcus species carriage in companion animals in the Greater Brisbane Area, Australia
Study date
2021
Authorising party
Public
Auth party contact address
-
Data no
291218
Author
Davies & Davies
Title
Origins and Evolution of Antibiotic Resistance
Study date
2010
Authorising party
Public
Auth party contact address
-
Data no
291219
Author
Saputra et al.
Title
Antimicrobial resistance in coagulase-positive staphylococciisolated from companion animals in Australia: A one yearstudy
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
291220
Author
Loeffler et al.
Title
Antimicrobial use guidelines for canine pyoderma by the International Society for Companion Animal Infectious Diseases (ISCAID)
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
291221
Author
Not Identified
Title
Human User Safety Assessment
Study date
November 2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date

Application Date

Application No

Application Number

150805
Product/Active constituent Name

Application Product Name

FYFANON 440 EW INSECTICIDE

Application details

Product name:

FYFANON 440 EW INSECTICIDE

Product number:

51150

Applicant Name:

FMC AUSTRALASIA PTY LTD

Application purpose and description of use:

Variation of product registration to amend the registered formulation.

Active constituents:

Active constituent name
44350 - Malathion

Description of data provided:

Data no
296111
Author
A. Obel
Title
Notarised Statutory Declaration of Mr. A Obel
Study date
2025
Authorising party
Applicant
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
296112
Author
Anon
Title
Appendix 2 - Formulation details
Study date
2025
Authorising party
Applicant
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
296113
Author
G. Hall
Title
DTS letter 3110 with attachments - 31 Oct 2025
Study date
2025
Authorising party
Applicant
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
296114
Author
Anon
Title
FMC Submission 3110 - 31 Oct 2025
Study date
2025
Authorising party
Applicant
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
296115
Author
Anon
Title
Additional lab documentation 1 - 481-21
Study date
2025
Authorising party
Applicant
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
296116
Author
Anon
Title
Additional lab documentation 2 - 481-24
Study date
2025
Authorising party
Applicant
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Date

Application Date

Application No

Application Number

149644
Product/Active constituent Name

Application Product Name

QA Chlorpyrifos 500 EC Insecticide

Application details

Product name:

QA Chlorpyrifos 500 EC Insecticide

Applicant Name:

QUANTUM AGROSCIENCES HOLDINGS PTY LTD

Application purpose and description of use:

Registration of a 500 g/L CHLORPYRIFOS emulsifiable concentrate (EC) product for the control of certain insect pests in various situations as per the directions for use table. THIS PRODUCT IS TOO HAZARDOUS FOR USE BY HOUSEHOLDERS  
Date

Application Date

Application No

Application Number

149648
Product/Active constituent Name

Application Product Name

QA Buffer 700

Application details

Product name:

QA Buffer 700

Applicant Name:

QUANTUM AGROSCIENCES HOLDINGS PTY LTD

Application purpose and description of use:

Registration of a 350 g/L Soyal Phosholipid, 350 g/L Propionic acid Dispersible concentrate product which is an Acidifying and Penetrating Surfactant; andReduces Alkaline Hydrolysis of Dimethoate Assists with Uptake of Foliar Fertilisers Assists in Management of Spray Droplet Size  
Date

Application Date

Application No

Application Number

150600
Product/Active constituent Name

Application Product Name

Beransa 30 mg Solution for Injection for Dogs

Application details

Product name:

Beransa 30 mg Solution for Injection for Dogs

Product number:

89695

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration to extend the shelf life.

Active constituents:

Active constituent name
89654 - Bedinvetmab

Description of data provided:

Data no
294326
Author
Zoetis Australia Pty Ltd
Title
Stability Summary report
Study date
October 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294327
Author
Anne Dewilde
Title
Stability Report
Study date
10 Apr 2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date

Application Date

Application No

Application Number

150649
Product/Active constituent Name

Application Product Name

Beransa 15 mg Solution for Injection for Dogs

Application details

Product name:

Beransa 15 mg Solution for Injection for Dogs

Product number:

89656

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration to extend the shelf-life.

Active constituents:

Active constituent name
89654 - Bedinvetmab

Description of data provided:

Data no
294438
Author
Zoetis Australia Pty Ltd
Title
Stability Summary report
Study date
October 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294439
Author
Anne Dewilde
Title
Stability report
Study date
10 April 2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date

Application Date

Application No

Application Number

150650
Product/Active constituent Name

Application Product Name

Beransa 20 mg Solution for Injection for Dogs

Application details

Product name:

Beransa 20 mg Solution for Injection for Dogs

Product number:

89655

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration to extend the shelf-life.

Active constituents:

Active constituent name
89654 - Bedinvetmab

Description of data provided:

Data no
294538
Author
Zoetis Australia Pty Ltd
Title
Stability Summary report
Study date
October 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294539
Author
Anne Dewilde
Title
Stability Report
Study date
10 April 2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date

Application Date

Application No

Application Number

150652
Product/Active constituent Name

Application Product Name

Beransa 10 mg Solution for Injection for Dogs

Application details

Product name:

Beransa 10 mg Solution for Injection for Dogs

Product number:

89657

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration to extend the shelf-life.

Active constituents:

Active constituent name
89654 - Bedinvetmab

Description of data provided:

Data no
294542
Author
Zoetis Australia Pty Ltd
Title
Stability Summary report
Study date
October 2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
294543
Author
Anne Dewilde
Title
Stability report
Study date
10 April 2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date

Application Date

Application No

Application Number

150702
Product/Active constituent Name

Application Product Name

Three X Triple Combination Drench for Sheep

Application details

Product name:

Three X Triple Combination Drench for Sheep

Product number:

94927

Applicant Name:

FOUR SEASONS AGRIBUSINESS PTY LTD

Application purpose and description of use:

Variation of product registration to vary the non-standard conditions.

Active constituents:

Active constituent name
82914 - Levamisole Hydrochloride
Active constituent name
88403 - ALBENDAZOLE
Active constituent name
82843 - ABAMECTIN
Active constituent name
57604 - SODIUM SELENATE
Active constituent name
91781 - Cobalt sulphate heptahydrate
Active constituent name
91782 - Zinc sulphate monohydrate

Description of data provided:

Data no
294665
Author
anon
Title
Manufacturers Declaration
Study date
13 October 2025
Authorising party
Manufacturer