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
148626
Product/Active constituent Name
Application Product Name
AMOXYCILLIN TRIHYDRATE
Application Date
Application Number
148626
Application Product Name
AMOXYCILLIN TRIHYDRATE
Application details
Product name:
AMOXYCILLIN TRIHYDRATE
Active name:
AMOXYCILLIN TRIHYDRATE
Applicant Name:
BIMEDA (AUSTRALIA) PTY. LIMITED
Application purpose and description of use:
Approval of amoxycillin trihydrate for use in veterinary chemical products.
Description of data provided:
Data no
286712
Title
Certificates of analysis
Study date
2024
Auth party contact address
C/- KPMG, LEVEL 38,Tower Three International Towers 300 Barangaroo Avenue SYDNEY Australia
Data no
286713
Title
Specifications
Study date
2024
Auth party contact address
C/- KPMG, LEVEL 38,Tower Three International Towers 300 Barangaroo Avenue SYDNEY Australia
Data no
286714
Title
Certificate
Study date
2024
Auth party contact address
C/- KPMG, LEVEL 38,Tower Three International Towers 300 Barangaroo Avenue SYDNEY Australia
Date
Application Date
Application No
Application Number
148072
Product/Active constituent Name
Application Product Name
DORAVET INJECTABLE ENDECTOCIDE
Application Date
Application Number
148072
Application Product Name
DORAVET INJECTABLE ENDECTOCIDE
Application details
Product name:
DORAVET INJECTABLE ENDECTOCIDE
Product number:
96071
Applicant Name:
VETPHARM PTY LIMITED
Application purpose and description of use:
Registration of a 10 mg/mL doramectin injectable product for the treatment and control of doramectin sensitive internal and external parasites of cattle and pigs.
Reference details:
84269 - DORAMAX INJECTABLE ENDECTOCIDE
Active constituents:
Active constituent name
94647 - doramectin
Active constituent name
84347 - DORAMECTIN
Active constituent name
94559 - DORAMECTIN
Description of data provided:
Data no
285122
Title
Product specifications
Study date
2025
Auth party contact address
7/20 St Johns Road Gordon Australia
Date
Application Date
Application No
Application Number
148681
Product/Active constituent Name
Application Product Name
NovaGuard Fosetyl-aluminium 800 WG Systemic Fungicide
Application Date
Application Number
148681
Application Product Name
NovaGuard Fosetyl-aluminium 800 WG Systemic Fungicide
Application details
Product name:
NovaGuard Fosetyl-aluminium 800 WG Systemic Fungicide
Product number:
96256
Applicant Name:
NOVAGUARD PTY LTD
Application purpose and description of use:
Registration of a 800 g/kg fosetyl-aluminium product for the prevention and control of phytophthora rots in apples,
avocados, ornamentals, peaches and pineapples
Reference details:
69400 - SUREFIRE ALSETYL 800WG SYSTEMIC FUNGICIDE
Active constituents:
Active constituent name
67917 - FOSETYL-ALUMINIUM
Date
Application Date
Application No
Application Number
148792
Product/Active constituent Name
Application Product Name
DURAMUNE MULTI C4 CANINE DISTEMPER, ADENOVIRUS, PARAINFLUENZA & PARVOVIRUS LIVE VACCINE
Application Date
Application Number
148792
Application Product Name
DURAMUNE MULTI C4 CANINE DISTEMPER, ADENOVIRUS, PARAINFLUENZA & PARVOVIRUS LIVE VACCINE
Application details
Product name:
DURAMUNE MULTI C4 CANINE DISTEMPER, ADENOVIRUS, PARAINFLUENZA & PARVOVIRUS LIVE VACCINE
Product number:
59731
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Variation of label approval to update the dosage and administration directions.
Active constituents:
Active constituent name
54990 - CANINE PARAINFLUENZA TYPE 2
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
83719 - CANINE PARAINFLUENZA VIRUS
Active constituent name
54990 - CANINE PARAINFLUENZA TYPE 2
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
287278
Title
2024 guidelines for the vaccination of dogs and cats
Study date
2024
Auth party contact address
-
Data no
295426
Title
Response to s159 Duramune C4
Study date
14/10/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
287277
Title
Executive Summary
Study date
05/06/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
295427
Title
Duramune Multi C4 dosage and administration
Study date
14/10/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date
Application Date
Application No
Application Number
148665
Product/Active constituent Name
Application Product Name
Marino 400 Herbicide
Application Date
Application Number
148665
Application Product Name
Marino 400 Herbicide
Application details
Product name:
Marino 400 Herbicide
Product number:
95630
Applicant Name:
TURF CULTURE PTY LTD
Application purpose and description of use:
Variation of product registration to add additional formulations.
Active constituents:
Active constituent name
65048 - METRIBUZIN
Description of data provided:
Data no
287574
Title
Method Validation for the determination of metribuzin in Metribuzin (Matrix White)
Study date
13 September 2023
Auth party contact address
43 Gap Road Sunbury Australia
Data no
287576
Title
Method Validation for the determination of metribuzin in Metribuzin (Matrix Brown)
Study date
13 September 2023
Auth party contact address
43 Gap Road Sunbury Australia
Data no
287578
Title
Marino 400 Herbicide - Formulations
Study date
May 2023
Auth party contact address
43 Gap Road Sunbury Australia
Data no
287579
Title
Excipient SDSs - White Formulation
Study date
May 2023
Auth party contact address
43 Gap Road Sunbury Australia
Data no
287580
Title
Excipient SDSs - Brown Formulation
Study date
May 2023
Auth party contact address
43 Gap Road Sunbury Australia
Data no
287577
Title
The development of an improved formulation of 400 g/L Metribuzin SC (Brown formulation)
Study date
September 2023
Auth party contact address
43 Gap Road Sunbury Australia
Data no
287575
Title
The development of an improved formulation of 400 g/L Metribuzin SC (White formulation)
Study date
September 2023
Auth party contact address
43 Gap Road Sunbury Australia
Data no
287583
Title
Bio-equivalence evaluation comparing Marino 400 Herbicide formulations.
Study date
December 2023
Auth party contact address
43 Gap Road Sunbury Australia
Data no
287584
Title
Bio-equivalence evaluation comparing Marino 400 Herbicide formulations.
Study date
December 2023
Auth party contact address
43 Gap Road Sunbury Australia
Data no
287581
Title
Bio-equivalence evaluation comparing Marino 400 Herbicide formulations.
Study date
July 2023
Auth party contact address
43 Gap Road Sunbury Australia
Data no
287582
Title
Bio-equivalence evaluation comparing Marino 400 Herbicide formulations.
Study date
July 2023
Auth party contact address
43 Gap Road Sunbury Australia
Date
Application Date
Application No
Application Number
148478
Product/Active constituent Name
Application Product Name
ILIUM PROPERCILLIN ANTIBIOTIC INJECTION
Application Date
Application Number
148478
Application Product Name
ILIUM PROPERCILLIN ANTIBIOTIC INJECTION
Application details
Product name:
ILIUM PROPERCILLIN ANTIBIOTIC INJECTION
Product number:
60521
Applicant Name:
TROY LABORATORIES PTY LTD
Application purpose and description of use:
Variation of product registration a to add an additional overseas site for manufacture.
Active constituents:
Active constituent name
60521 - ILIUM PROPERCILLIN ANTIBIOTIC INJECTION
Active constituent name
84166 - PROCAINE BENZYLPENICILLIN
Description of data provided:
Data no
286928
Title
Certificate of GMP
Study date
2025
Auth party contact address
37 GLENDENNING ROAD GLENDENNING Australia
Date
Application Date
Application No
Application Number
148658
Product/Active constituent Name
Application Product Name
NovaGuard Pyriproxyfen 100 Insect Growth Regulator
Application Date
Application Number
148658
Application Product Name
NovaGuard Pyriproxyfen 100 Insect Growth Regulator
Application details
Product name:
NovaGuard Pyriproxyfen 100 Insect Growth Regulator
Product number:
96250
Applicant Name:
NOVAGUARD PTY LTD
Application purpose and description of use:
Registration of 100 g/L pyriproxyfen emulsifiable concentrate product for the control of silverleaf whitefly (Bemisia tabaci Biotype B) in cotton, rockmelon and capsicum, the control of silverleaf whitefly (Bemisia tabaci Biotype B) and greenhouse whitefly in tomatoes, and the control of various scale in citrus, mangoes and olives.
Reference details:
86921 - Surefire Ensign 100 Insect Growth Regulator
Active constituents:
Active constituent name
93795 - Pyriproxyfen
Date
Application Date
Application No
Application Number
148603
Product/Active constituent Name
Application Product Name
NovaGuard Boscalid 500 WG Fungicide
Application Date
Application Number
148603
Application Product Name
NovaGuard Boscalid 500 WG Fungicide
Application details
Product name:
NovaGuard Boscalid 500 WG Fungicide
Product number:
96231
Applicant Name:
NOVAGUARD PTY LTD
Application purpose and description of use:
Registration of a 500 g/kg boscalid water dispersible granule product for the Control of Bunch Rot (Botrytis cinerea) in Grapevines
Reference details:
70146 - FMC PATRON 500 WG FUNGICIDE
Active constituents:
Active constituent name
90492 - BOSCALID
Date
Application Date
Application No
Application Number
148334
Product/Active constituent Name
Application Product Name
Bixafen
Application Date
Application Number
148334
Application Product Name
Bixafen
Application details
Product name:
Bixafen
Active name:
Bixafen
Applicant Name:
CONQUEST CROP PROTECTION PTY LTD
Application purpose and description of use:
Approval of a new source of bixafen for use in agricultural products
The impurity and toxicological profiles of the proposed new source of bixafen are believed to be similar to those of APVMA-approved sources of bixafen .
Description of data provided:
Data no
286452
Title
(3) - Five-Batch Analysis of Bixafen
Study date
Oct 2024
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
286454
Title
(5) - Certificate of analysis, 5 Batches
Study date
July 2024
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
286450
Title
(1)- Part 2 - Chemistry and Manufacture
Study date
April 2025
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
286451
Title
(2) - Manufacturing Process of BixafenTechnical
Study date
Nov 2024
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
286453
Title
(4) - Declaration of Composition for Bixafen
Study date
April 2025
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Date
Application Date
Application No
Application Number
148614
Product/Active constituent Name
Application Product Name
Eurochem Zippo 500WG Fungicide
Application Date
Application Number
148614
Application Product Name
Eurochem Zippo 500WG Fungicide
Application details
Product name:
Eurochem Zippo 500WG Fungicide
Product number:
96235
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.
Reference details:
85778 - Surefire Invictus 500 WG Fungicide
Active constituents:
Active constituent name
80311 - TRIFLOXYSTROBIN
Description of data provided:
Data no
287404
Title
CONSENT FOR USE OF CONFIDENTIAL COMMERCIAL INFORMATION
Study date
6 May 2025
Auth party contact address
9 Heales Road Lara Australia
Date
Application Date
Application No
Application Number
148588
Product/Active constituent Name
Application Product Name
Placate 250 EC Fungicide
Application Date
Application Number
148588
Application Product Name
Placate 250 EC Fungicide
Application details
Product name:
Placate 250 EC Fungicide
Product number:
96228
Applicant Name:
PARIJAT INDUSTRIES (INDIA) LIMITED
Application purpose and description of use:
Registration of a 250 g/L pyraclostrobin emulsifiable concentrate product for the control of leaf speckle, leaf spot and Black Sigatoga in bananas and downy and powdery mildew in grapevines, husk spot in macadamia and rust in almond.
Reference details:
84299 - Surefire Symbio 250 EC Fungicide
Active constituents:
Active constituent name
82863 - PYRACLOSTROBIN
Date
Application Date
Application No
Application Number
148335
Product/Active constituent Name
Application Product Name
ECOMIST ENHANCING YOUR ENVIRONMENT INSECT GRENADE WITH EGGBUSTERS
Application Date
Application Number
148335
Application Product Name
ECOMIST ENHANCING YOUR ENVIRONMENT INSECT GRENADE WITH EGGBUSTERS
Application details
Product name:
ECOMIST ENHANCING YOUR ENVIRONMENT INSECT GRENADE WITH EGGBUSTERS
Product number:
69305
Applicant Name:
DAMAR INDUSTRIES PTY LIMITED
Application purpose and description of use:
Variation of product label approval to update label in accordance with the FAISD handbook and the Australian and New Zealand harmonised labelling for aerosol products.
Active constituents:
Active constituent name
44422 - PERMETHRIN
Active constituent name
44502 - PERMETHRIN
Active constituent name
50875 - PYRIPROXYFEN
Active constituent name
56092 - PIPERONYL BUTOXIDE
Date
Application Date
Application No
Application Number
148337
Product/Active constituent Name
Application Product Name
ECOMIST ENHANCING YOUR ENVIRONMENT INSECT SNIPER RESIDUAL SURFACE SPRAY
Application Date
Application Number
148337
Application Product Name
ECOMIST ENHANCING YOUR ENVIRONMENT INSECT SNIPER RESIDUAL SURFACE SPRAY
Application details
Product name:
ECOMIST ENHANCING YOUR ENVIRONMENT INSECT SNIPER RESIDUAL SURFACE SPRAY
Product number:
69306
Applicant Name:
DAMAR INDUSTRIES PTY LIMITED
Application purpose and description of use:
Variation of product label approval to update label in accordance with the FAISD Handbook and the Australian and New Zealand harmonised labelling for aerosol products.
Active constituents:
Active constituent name
50869 - TETRAMETHRIN [(1R)- ISOMERS]
Active constituent name
50874 - CYPHENOTHRIN
Date
Application Date
Application No
Application Number
148441
Product/Active constituent Name
Application Product Name
Pimoway 5 mg Flavoured Chewable Tablet for Dogs
Application Date
Application Number
148441
Application Product Name
Pimoway 5 mg Flavoured Chewable Tablet for Dogs
Application details
Product name:
Pimoway 5 mg Flavoured Chewable Tablet for Dogs
Product number:
96179
Applicant Name:
HEADWAY INVESTMENTS PTY LTD
Application purpose and description of use:
Registration of a 5 mg pimobendan tablet product for canine congestive heart failure.
Reference details:
84158 - Vetmedin 5 mg Flavoured Chewable Tablets for Dogs
Active constituents:
Active constituent name
96175 - Pimobendan
Date
Application Date
Application No
Application Number
148442
Product/Active constituent Name
Application Product Name
Pimoway 2.5 mg Flavoured Chewable Tablet for Dogs
Application Date
Application Number
148442
Application Product Name
Pimoway 2.5 mg Flavoured Chewable Tablet for Dogs
Application details
Product name:
Pimoway 2.5 mg Flavoured Chewable Tablet for Dogs
Product number:
96180
Applicant Name:
HEADWAY INVESTMENTS PTY LTD
Application purpose and description of use:
Registration of a 2.5 mg pimobendan tablet for the treatment of canine congestive heart failure. .
Reference details:
84156 - Vetmedin 2.5 mg Flavoured Chewable Tablets for Dogs
Active constituents:
Active constituent name
96175 - Pimobendan
Date
Application Date
Application No
Application Number
148549
Product/Active constituent Name
Application Product Name
Multimin Chrome Injection for Cattle
Application Date
Application Number
148549
Application Product Name
Multimin Chrome Injection for Cattle
Application details
Product name:
Multimin Chrome Injection for Cattle
Product number:
90447
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Variation of product label approval
Active constituents:
Active constituent name
84564 - DISODIUM ZINC EDTA
Active constituent name
89748 - Disodium Manganese EDTA
Active constituent name
84566 - DISODIUM COPPER EDTA
Active constituent name
83575 - Sodium Selenite
Active constituent name
90444 - Chromium chloride hexahydrate
Active constituent name
90445 - Chromium chloride hexahydrate
Active constituent name
90446 - Disodium manganese EDTA
Description of data provided:
Data no
286481
Title
Cover Letter
Study date
2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Date
Application Date
Application No
Application Number
148437
Product/Active constituent Name
Application Product Name
Pimobendan
Application Date
Application Number
148437
Application Product Name
Pimobendan
Application details
Product name:
Pimobendan
Active name:
Pimobendan
Applicant Name:
HEADWAY INVESTMENTS PTY LTD
Application purpose and description of use:
New source of pharmacopoeia active constituent
Date
Application Date
Application No
Application Number
148436
Product/Active constituent Name
Application Product Name
Pimoway 10 mg Flavoured Chewable Tablets for Dogs
Application Date
Application Number
148436
Application Product Name
Pimoway 10 mg Flavoured Chewable Tablets for Dogs
Application details
Product name:
Pimoway 10 mg Flavoured Chewable Tablets for Dogs
Product number:
96174
Applicant Name:
HEADWAY INVESTMENTS PTY LTD
Application purpose and description of use:
Registration of a 10 mg pimobendan tablet product for dogs with congestive heart failure.
Reference details:
84154 - Vetmedin 10 mg Flavoured Chewable Tablets for Dogs
Active constituents:
Active constituent name
96175 - Pimobendan
Description of data provided:
Data no
286182
Title
Chemistry and Manufacture Volume 1
Study date
2025
Auth party contact address
2 Kippax St GREYSTANES Australia
Data no
286183
Title
Chemistry and Manufacture Volume 2
Study date
2025
Auth party contact address
2 Kippax St GREYSTANES Australia
Data no
286184
Title
Chemistry and Manufacture Volume 3
Study date
2025
Auth party contact address
2 Kippax St GREYSTANES Australia
Data no
286185
Title
Chemistry and Manufacture Volume 4 Part 1
Study date
2025
Auth party contact address
2 Kippax St GREYSTANES Australia
Data no
286186
Title
Chemistry and Manufacture Volume 4 Part 2
Study date
2025
Auth party contact address
2 Kippax St GREYSTANES Australia
Data no
286187
Title
Chemistry and Manufacture Volume 4 Part 3
Study date
2025
Auth party contact address
2 Kippax St GREYSTANES Australia
Data no
286196
Title
Confirmation of Overseas site GMP Compliance
Study date
2023
Auth party contact address
2 Kippax St GREYSTANES Australia
Data no
286189
Title
Safety and Efficacy volume 1
Study date
2025
Auth party contact address
2 Kippax St GREYSTANES Australia
Data no
286190
Title
Efficacy of pimobendan in the prevention of congestive heart failure or sudden death in Doberman Pinschers with preclinical dilated cardiomyopathy (the PROTECT Study).
Study date
2016
Auth party contact address
-
Data no
286191
Title
The effect of treatment with pimobendan in dogs with preclinical mitral valve disease - a placebo-controlled double-blinded crossover study.
Study date
2021
Auth party contact address
-
Data no
286192
Title
Efficacy of pimobendan on survival and reoccurrence of pulmonary edema in canine congestive heart failure.
Study date
2017
Auth party contact address
-
Data no
286193
Title
Effects of pimobendan on myocardial perfusion and pulmonary transit time in dogs with myxomatous mitral valve disease: a pilot study.
Study date
2016
Auth party contact address
-
Data no
286194
Title
Effect of pimobendan on the incidence of arrhythmias in small breed dogs with myxomatous mitral valve degeneration.
Study date
2015
Auth party contact address
-
Data no
286195
Title
Efficacy and safety of pimobendan in canine heart failure caused by myxomatous mitral valve disease.
Study date
2005
Auth party contact address
-
Data no
286181
Title
Executive Summary
Study date
2025
Auth party contact address
2 Kippax St GREYSTANES Australia
Data no
286188
Title
Biosecurity Application
Study date
2025
Auth party contact address
2 Kippax St GREYSTANES Australia
Date
Application Date
Application No
Application Number
148572
Product/Active constituent Name
Application Product Name
Vitamin D3 (Cholecalciferol)
Application Date
Application Number
148572
Application Product Name
Vitamin D3 (Cholecalciferol)
Application details
Product name:
Vitamin D3 (Cholecalciferol)
Active name:
Vitamin D3 (Cholecalciferol)
Applicant Name:
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
Application purpose and description of use:
Approval of Vitamin D3 (Cholecalciferol) for use in agricultural and veterinary chemical products.
Description of data provided:
Data no
286555
Title
Certificates of analysis
Study date
2024
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
286557
Title
Five Batch Analysis of Cholecalciferol (Vitamin D3) Technical
Study date
03/04/2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
286558
Title
Declaration of composition
Study date
28/04/2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
286556
Title
CHEMISTRY & MANUFACTURE
Study date
2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Date
Application Date
Application No
Application Number
148625
Product/Active constituent Name
Application Product Name
1-Methylcyclopropene
Application Date
Application Number
148625
Application Product Name
1-Methylcyclopropene
Application details
Product name:
1-Methylcyclopropene
Active name:
1-Methylcyclopropene
Applicant Name:
FRESH INSET S.A.
Application purpose and description of use:
New source of active constituent
Description of data provided:
Data no
286831
Title
2.3 DoC for 1-methylcyclopropene
Study date
April 2025
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286832
Title
2.4 Analysis of 5 batches of 1-MCP Technical Material to Determine the Content of Active Ingredient and Specified Impurities, in Compliance with Good Laboratory Practice
Study date
November 2019
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286830
Title
2.2 Synthesis of 1-methylcyclopropene (1-MCP)
Study date
April 2025
Auth party contact address
Wilenska Street 4 /A017 Torun Poland
Data no
286829
Title
2.1 Spectral data for 1-metylocyklopropene (1-MCP)
Study date
April 2025
Auth party contact address
Wilenska Street 4 /A017 Torun Poland