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

154464
Product/Active constituent Name

Application Product Name

Hortico Weed Killer 360 Concentrate

Application details

Product name:

Hortico Weed Killer 360 Concentrate

Applicant Name:

DULUXGROUP (AUSTRALIA) PTY LTD

Application purpose and description of use:

Registration of a 360 g/L glyphosate (present as the isopropylamine salt) aqueous concentrate product for killing weeds and grasses.
Date

Application Date

Application No

Application Number

154477
Product/Active constituent Name

Application Product Name

Stadium Turf Selective Herbicide B

Application details

Product name:

Stadium Turf Selective Herbicide B

Applicant Name:

ADAMA AUSTRALIA PTY LIMITED

Application purpose and description of use:

Registration of a Diflufenican 15 g/L + MCPA 300 g/L + Clopyralid 20 g/L SC for uses as proposed in the Directions for Use table.
Date

Application Date

Application No

Application Number

152654
Product/Active constituent Name

Application Product Name

Kato Trilostane 60 mg Tablets for Dogs

Application details

Product name:

Kato Trilostane 60 mg Tablets for Dogs

Product number:

97293

Applicant Name:

KATO LABORATORIES PTY LTD

Application purpose and description of use:

Registration of a 60 mg trilostane tablet for the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism (Cushing's syndrome) in dogs.

Reference details:

60619 - VETORYL 60 MG CAPSULES
60618 - VETORYL 120 MG CAPSULES
60620 - VETORYL 30 MG CAPSULES
95041 - VETORYL 20 MG CAPSULES
64707 - VETORYL 10 MG CAPSULES
90588 - VETORYL 5MG CAPSULES

Active constituents:

Active constituent name
95594 - TRILOSTANE

Description of data provided:

Data no
303506
Author
Sheskey PJ et al
Title
Handbook of Pharmaceutical Excipients
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
303483
Author
Anon
Title
Analytical method validation
Study date
2023
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303475
Author
Anon
Title
Specifications
Study date
2024
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303492
Author
Anon
Title
Study discussion
Study date
2025
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303486
Author
Anon
Title
Stability 2
Study date
2025
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303472
Author
Anon
Title
Product specifications
Study date
2026
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303495
Author
Anon
Title
SPC
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
303489
Author
Anon
Title
Study report 1
Study date
2024
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303503
Author
Anon
Title
Data
Study date
2026
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303481
Author
Anon
Title
Analytical method
Study date
2023
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303487
Author
Anon
Title
Stability 3
Study date
2026
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303490
Author
Anon
Title
Study report 2
Study date
2025
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303498
Author
Anon
Title
Assessment report
Study date
2019
Authorising party
Public
Auth party contact address
-
Data no
303504
Author
Anon
Title
Data
Study date
2026
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303484
Author
Anon
Title
Analytical method validation
Study date
2023
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303507
Author
Anon
Title
VIN Veterinary Drug Handbook
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
303478
Author
Anon
Title
Batch packaging record
Study date
2023
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303501
Author
Anon
Title
Dissolution method
Study date
2024
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303485
Author
Anon
Title
Stability 1
Study date
2025
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303473
Author
Anon
Title
Part 2 dossier
Study date
2026
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303479
Author
Anon
Title
Packaging specifications
Study date
2023
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303496
Author
Anon
Title
SPC
Study date
2026
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303502
Author
Anon
Title
Assay test method
Study date
2023
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303505
Author
Anon
Title
Assessment report
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
303482
Author
Anon
Title
Analytical method
Study date
2023
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303476
Author
Anon
Title
Certificates of analysis
Study date
2023
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303493
Author
Anon
Title
Assessment report
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
303499
Author
Anon
Title
Dissolution study
Study date
2026
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303508
Author
Anon
Title
Assessment report
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
303477
Author
Anon
Title
Batch manufacturing record
Study date
2023
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303494
Author
Anon
Title
Assessment report
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
303500
Author
Anon
Title
Abstract
Study date
2026
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303488
Author
Anon
Title
Part 8 dossier
Study date
2026
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303474
Author
Anon
Title
Certificate of analysis
Study date
2024
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303480
Author
Anon
Title
Batch analysis
Study date
2024
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303491
Author
Anon
Title
Study report 3
Study date
2025
Authorising party
Applicant
Auth party contact address
61 CHIVERS RD SOMERSBY Australia
Data no
303497
Author
Anon
Title
Patent
Study date
2024
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

152655
Product/Active constituent Name

Application Product Name

Kato Trilostane 10 mg Tablets for Dogs

Application details

Product name:

Kato Trilostane 10 mg Tablets for Dogs

Product number:

97294

Applicant Name:

KATO LABORATORIES PTY LTD

Application purpose and description of use:

Registration of a 10 mg trilostane tablet for the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism (Cushing's syndrome) in dogs.

Reference details:

64707 - VETORYL 10 MG CAPSULES
60620 - VETORYL 30 MG CAPSULES
60619 - VETORYL 60 MG CAPSULES
60618 - VETORYL 120 MG CAPSULES
95041 - VETORYL 20 MG CAPSULES
90588 - VETORYL 5MG CAPSULES

Active constituents:

Active constituent name
95594 - TRILOSTANE
Date

Application Date

Application No

Application Number

154462
Product/Active constituent Name

Application Product Name

GlanEry 7 in 1 B12 Vaccine for Sheep

Application details

Product name:

GlanEry 7 in 1 B12 Vaccine for Sheep

Product number:

89053

Applicant Name:

ZOETIS AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration to remove non-standard conditions

Active constituents:

Active constituent name
83726 - CLOSTRIDIUM NOVYI TYPE B - TOXOID
Active constituent name
83727 - CLOSTRIDIUM SEPTICUM - TOXOID
Active constituent name
83728 - CLOSTRIDIUM CHAUVOEI - TOXOID
Active constituent name
83730 - CLOSTRIDIUM TETANI - TOXOID
Active constituent name
83729 - CLOSTRIDIUM PERFRINGENS TYPE D - TOXOID
Active constituent name
83733 - Corynebacterium pseudotuberculosis (ovis) - toxoid
Active constituent name
84224 - ERYSIPELOTHRIX RHUSIOPATHIAE
Active constituent name
84266 - HYDROXOCOBALAMIN ACETATE
Active constituent name
88084 - Hydroxocobalamin Acetate

Description of data provided:

Data no
311221
Author
Zoetis Australia Research and Manufacturing
Title
Att-s159-1 Stability Protocol Glanery 7 in 1
Study date
2024
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
311222
Author
Zoetis Australia Pty Ltd
Title
2026-09-02 - s159 notice 89053_154462 applicant response
Study date
2026
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
307579
Author
Zoetis Australia Pty Ltd
Title
Attachment 1 - GlanEry 7 in 1 B12 Stability Report
Study date
2025
Authorising party
Applicant
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Date

Application Date

Application No

Application Number

154522
Product/Active constituent Name

Application Product Name

KELPIE PROMIX 550 GLY HERBICIDE

Application details

Product name:

KELPIE PROMIX 550 GLY HERBICIDE

Applicant Name:

SINOCHEM INTERNATIONAL AUSTRALIA PTY. LTD.

Application purpose and description of use:

Registration of a 550 g/L GLYPHOSATE present as the potassium salt and monoethanolamine salts soluble concentrate (SL) product for non selective herbicide for the control of many annual and perennial weed..
Date

Application Date

Application No

Application Number

154161
Product/Active constituent Name

Application Product Name

Sipcam Raze Herbicide

Application details

Product name:

Sipcam Raze Herbicide

Applicant Name:

SIPCAM PACIFIC AUSTRALIA PTY. LIMITED

Application purpose and description of use:

Registration of a 510 g/L glyphosate aqueous concentrate product for control of a wide range of annual and perennial weeds in a wide variety of situations (as per the Directions for Use table).
Date

Application Date

Application No

Application Number

154265
Product/Active constituent Name

Application Product Name

SMART HALOXYFOP 520 EC HERBICIDE B

Application details

Product name:

SMART HALOXYFOP 520 EC HERBICIDE B

Applicant Name:

CROP SMART PTY LTD

Application purpose and description of use:

Registration of a 520 g/L HALOXYFOP present as the haloxyfop-P methyl ester emulsifiable concentrate product for the post-emergent control of a wide range of annual and perennial grass weeds in grain legume and oilseed crops, lucerne, medic and clover pasture and seed crops, forestry, bananas, citrus, grapes, pineapples, pome and stone fruit, pyrethrum, tropical fruit and nut crops as specified in the Directions for Use.
Date

Application Date

Application No

Application Number

154186
Product/Active constituent Name

Application Product Name

RECEPTOR INSECTICIDE

Application details

Product name:

RECEPTOR INSECTICIDE

Applicant Name:

ADAMA AUSTRALIA PTY LIMITED

Application purpose and description of use:

Registration of a 500 g/L diafenthiuron suspension concentrate product for use as proposed in the directions for use.
Date

Application Date

Application No

Application Number

154111
Product/Active constituent Name

Application Product Name

GENERO 600 FLOWABLE SEED DRESSING INSECTICIDE

Application details

Product name:

GENERO 600 FLOWABLE SEED DRESSING INSECTICIDE

Applicant Name:

ECHEM (AUST) PTY LIMITED

Application purpose and description of use:

Registration of a 600 g/L Imidacloprid Suspension concentrates for seed treatment (FS)product for the control of thrips, aphids, brown flea beetle and wireworms on cotton, protection of canola, pastures and lupins from damage by redlegged earth mite and blue oat mite; control of aphids and prevention of spread of barley yellow dwarf virus in cereal crops; control of some soil pests of summer crops.
Date

Application Date

Application No

Application Number

154136
Product/Active constituent Name

Application Product Name

GENFARM FLUTRIAFOL 500 SC FUNGICIDE B

Application details

Product name:

GENFARM FLUTRIAFOL 500 SC FUNGICIDE B

Applicant Name:

NUTRIEN AG SOLUTIONS LIMITED

Application purpose and description of use:

Registration of a 500 g/L suspension concentrate flutriafol fungicide for the control of certain fungal diseases on wheat, barley and canola when mixed with fertiliser.
Date

Application Date

Application No

Application Number

154163
Product/Active constituent Name

Application Product Name

Agroxone 750 Herbicide

Application details

Product name:

Agroxone 750 Herbicide

Applicant Name:

SIPCAM PACIFIC AUSTRALIA PTY. LIMITED

Application purpose and description of use:

Registration of a 750g/L MCPA aqueous concentrate product for use in cereals, linseed, pastures, rice, sugar cane and turf (as per the Directions for Use)
Date

Application Date

Application No

Application Number

154165
Product/Active constituent Name

Application Product Name

LVE MCPA 570 Herbicide

Application details

Product name:

LVE MCPA 570 Herbicide

Applicant Name:

SIPCAM PACIFIC AUSTRALIA PTY. LIMITED

Application purpose and description of use:

Registration of a 570g/L MCPA (present as the 2-ethylhexyll ester) emulsifiable concentrate product for the selective control of certain weeds in agricultural products (as specified in the Directions for Use table.
Date

Application Date

Application No

Application Number

154197
Product/Active constituent Name

Application Product Name

Quali-Pro Twister Insecticide A

Application details

Product name:

Quali-Pro Twister Insecticide A

Applicant Name:

ADAMA AUSTRALIA PTY LIMITED

Application purpose and description of use:

Registration of a 320 g/L Indoxacarb (75:25) (equivalent to 240 g/L active S-isomer) plus 80 g/L Novaluron suspension concentrate (SC) product for use as proposed in the directions for use.
Date

Application Date

Application No

Application Number

154207
Product/Active constituent Name

Application Product Name

Smart Carfentrazone 400 EC Herbicide B

Application details

Product name:

Smart Carfentrazone 400 EC Herbicide B

Applicant Name:

CROP SMART PTY LTD

Application purpose and description of use:

Registration of a 400 g/L CARFENTRAZONE-ETHYL Emulsifiable Concentrate product used of for improvement in the control of marshmallow and certain other broadleaf weeds prior to establishment of broadacre crops, fallows or forest plantations, in commercial, industrial and public service areas, around agricultural buildings and yards, in tree fruits, nuts, grape vines in tank mixture with knockdown herbicides; for the control of marshmallow and annual nettles in grass pastures and rough grass/turf areas; and control of volunteer cotton seedlings including Roundup Ready cotton and desiccation of cotton re- growth as per the Directions For Use Table.
Date

Application Date

Application No

Application Number

154247
Product/Active constituent Name

Application Product Name

ALBAUGH SPERTO 680 EC Herbicide B

Application details

Product name:

ALBAUGH SPERTO 680 EC Herbicide B

Applicant Name:

ALBAUGH AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 680 g/L 2,4-D present as the 2-ethylhexyl ester emulsifiable concentrate product for selective control of various weeds in crops, pastures and non-agricultural areas as per the Directions for Use table.
Date

Application Date

Application No

Application Number

154255
Product/Active constituent Name

Application Product Name

Smart SAYONARA 850 WG Herbicide B

Application details

Product name:

Smart SAYONARA 850 WG Herbicide B

Applicant Name:

CROP SMART PTY LTD

Application purpose and description of use:

Registration of a 850 g/kg PYROXASULFONE water dispersible granule product for the pre-emergence control of annual ryegrass, barley grass, annual phalaris, silver grass and toad rush and suppression of certain grass weeds in wheat (not durum wheat) and triticale as specified in the DIRECTIONS FOR USE table
Date

Application Date

Application No

Application Number

154387
Product/Active constituent Name

Application Product Name

Titan Besuto 850 WG Herbicide C

Application details

Product name:

Titan Besuto 850 WG Herbicide C

Applicant Name:

TITAN AG PTY LTD

Application purpose and description of use:

Registration of a 850g/kg Pyroxasulfone product for the pre-emergence control of annual ryegrass, barley grass, annual phalaris, silvergrass and toad rush and suppression of certain grass weeds in wheat (not durum wheat), triticale and certain winter legume crops as specified in the DIRECTIONS FOR USE.
Date

Application Date

Application No

Application Number

154428
Product/Active constituent Name

Application Product Name

Titan Besuto 850 WG Herbicide B

Application details

Product name:

Titan Besuto 850 WG Herbicide B

Applicant Name:

TITAN AG PTY LTD

Application purpose and description of use:

Registration of a 850g.kg Pyroxasulfone product for the pre-emergence control of annual ryegrass, barley grass, annual phalaris, silvergrass and toad rush and suppression of certain grass weeds in wheat (not durum wheat), triticale and certain winter legume crops as specified in the DIRECTIONS FOR USE.
Date

Application Date

Application No

Application Number

154486
Product/Active constituent Name

Application Product Name

CYTOPOINT Solution for Injection for Dogs 30 mg

Application details

Product name:

CYTOPOINT Solution for Injection for Dogs 30 mg

Product number:

83545

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
307634
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
Data no
307637
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
307640
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
307632
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
307638
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
307641
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
307635
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
307636
Author
EMA
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
307633
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
307639
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