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

151576
Product/Active constituent Name

Application Product Name

RAPPORT HERBICIDE

Application details

Product name:

RAPPORT HERBICIDE

Product number:

97019

Applicant Name:

UPL AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 33g/L Imazamox as the ammonium salt and 15 g/L imazapyr present as the ammonium salt product in a soluble concentrates (SL) formulation for the early post-emergence control of certain grass and broadleaf weeds as part of the Clearfield Production System for Clearfield Plus wheat, Clearfield barley, Clearfield canola and igrowth herbicide tolerant grain sorghum, as specified in the Directions for use.

Reference details:

59735 - INTERVIX HERBICIDE
Date

Application Date

Application No

Application Number

149068
Product/Active constituent Name

Application Product Name

Live attenuated feline Chlamydia felis strain Baker

Application details

Product name:

Live attenuated feline Chlamydia felis strain Baker

Product number:

96356

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Registration of a live attenuated pentavalent vaccine comprising of feline calicivirus, feline herpesvirus, feline panleucopenia virus, Chlamydia felis and feline leukopenia virus RNA-particles, for use in cats. In conjunction with approval of two new active constituents, C. felis and RP-FeLV.
Date

Application Date

Application No

Application Number

149071
Product/Active constituent Name

Application Product Name

Feline leukemia virus glycoprotein RNA Particles

Application details

Product name:

Feline leukemia virus glycoprotein RNA Particles

Product number:

96358

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Registration of a live attenuated pentavalent vaccine comprising of feline calicivirus, feline herpesvirus, feline panleucopenia virus, Chlamydia felis and feline leukopenia virus RNA-particles, for use in cats. In conjunction with approval of two new active constituents, C. felis and RP-FeLV.
Date

Application Date

Application No

Application Number

150207
Product/Active constituent Name

Application Product Name

Mirtazapine

Application details

Product name:

Mirtazapine

Product number:

96640

Applicant Name:

DECHRA REGULATORY B.V.

Application purpose and description of use:

Registration of a 20 mg/g mirtazapine ointment product for cats for body weight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions, in conjunction with approval of mirtazapine.
Date

Application Date

Application No

Application Number

150208
Product/Active constituent Name

Application Product Name

Mirataz Transdermal Ointment for Cats

Application details

Product name:

Mirataz Transdermal Ointment for Cats

Product number:

96641

Applicant Name:

DECHRA REGULATORY B.V.

Application purpose and description of use:

Registration of a 20 mg/g mirtazapine ointment product for cats for body weight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions, in conjunction with approval of mirtazapine.
Date

Application Date

Application No

Application Number

149069
Product/Active constituent Name

Application Product Name

Nobivac NXT HCPChFeLV Live Vaccine for cats

Application details

Product name:

Nobivac NXT HCPChFeLV Live Vaccine for cats

Product number:

96357

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Registration of a live attenuated pentavalent vaccine comprising of feline calicivirus, feline herpesvirus, feline panleucopenia virus, Chlamydia felis and feline leukopenia virus RNA-particles, for use in cats. In conjunction with approval of two new active constituents, C. felis and RP-FeLV.

Description of data provided:

Data no
307797
Author
Eudra
Title
Eudra GMP Site 4, USA
Study date
24 Apr 2026
Authorising party
Public
Auth party contact address
-
Data no
307791
Author
OGTR
Title
DIR 220 - RARMP Commercial supply of multivalent cat vaccines containing a genetically modified component for the prevention of feline leukemia virus infection
Study date
Apr 2026
Authorising party
Public
Auth party contact address
-
Data no
307800
Author
Intervet AH Pty Limited
Title
Applicant responses to s159 **READ FIRST**
Study date
10 July 2026
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
307794
Author
Intervet AH Pty Limited
Title
Nobivac NXT HCPChFeLV Toxicology Risk Assessment
Study date
17 July 2026
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
304328
Author
Intervet Australia Pty Limited
Title
Response to s159 notice dated 14 April 2026.
Study date
14 Apr 2026
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
307795
Author
Intervet AH Australia Pty Limited
Title
Site 2 - Steps of manufacture and Address
Study date
17 Jul 2026
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
307789
Author
EMA
Title
EMA.CVMP/75635/2026-Rev.1 Nobivac NXT HCPChFeLV
Study date
19 Jun 2026
Authorising party
Public
Auth party contact address
-
Data no
307798
Author
Eudra
Title
Eudra GMP Site 5
Study date
28 Jul 2025
Authorising party
Public
Auth party contact address
-
Data no
307792
Author
EU official departments
Title
EU Directive 2000-54-EC on the protection of workers from risks related to exposure to biological agents at work
Study date
17 Oct 2000
Authorising party
Public
Auth party contact address
-
Data no
307793
Author
Intervet AH Pty Limited
Title
Information for TGA Scheduling application
Study date
17 July 2026
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
307790
Author
OGTR
Title
Commercial supply of multivalent cat vaccines containing a genetically modified component for the prevention of feline leukemia virus infection.
Study date
6 Jul 2026
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
307799
Author
Eudra
Title
Eudra GMP Site 6
Study date
4 Dec 2025
Authorising party
Public
Auth party contact address
-
Data no
307796
Author
Eudra
Title
Eudra GMP Site 3
Study date
24 Apr 2026
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

151526
Product/Active constituent Name

Application Product Name

Amtole 250 Herbicide

Application details

Product name:

Amtole 250 Herbicide

Product number:

91975

Applicant Name:

Shandong Rainbow International Co Ltd

Application purpose and description of use:

Variation of the product label approval to add uses from the reference product label.

Reference details:

31236 - NUFARM AMITROLE T HERBICIDE
Date

Application Date

Application No

Application Number

151594
Product/Active constituent Name

Application Product Name

Mandipropamid

Application details

Product name:

Mandipropamid

Active name:

Mandipropamid

Applicant Name:

GREENCHEM HK LTD

Application purpose and description of use:

Approval of Mandipropamid for use in agricultural chemical products.
Date

Application Date

Application No

Application Number

151608
Product/Active constituent Name

Application Product Name

IMTRADE ENVIROPINK HOME & GARDEN GB MOLLUSCICIDE

Application details

Product name:

IMTRADE ENVIROPINK HOME & GARDEN GB MOLLUSCICIDE

Product number:

97036

Applicant Name:

IMTRADE AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 120g/kg IRON EDTA COMPLEX granular bait for the control of Snails and Slugs in Home & Garden situations as specified in the Directions for Use table.

Reference details:

90221 - 4FARMERS IRON CHELATE SNAIL AND SLUG BAIT
Date

Application Date

Application No

Application Number

151200
Product/Active constituent Name

Application Product Name

Esomeprazole Magnesium Trihydrate

Application details

Product name:

Esomeprazole Magnesium Trihydrate

Product number:

96901

Applicant Name:

VIRBAC (AUSTRALIA) PTY LTD

Application purpose and description of use:

Registration of a 240mg/mL esomeprazole oral paste product for horses, in conjunction with approval of active constituent.
Date

Application Date

Application No

Application Number

151201
Product/Active constituent Name

Application Product Name

Esomeprazole Magnesium Trihydrate

Application details

Product name:

Esomeprazole Magnesium Trihydrate

Product number:

96902

Applicant Name:

VIRBAC (AUSTRALIA) PTY LTD

Application purpose and description of use:

Registration of a 240mg/mL esomeprazole oral paste product for horses, in conjunction with approval of active constituent.
Date

Application Date

Application No

Application Number

151202
Product/Active constituent Name

Application Product Name

Gastrozol Gold Oral Paste for Horses

Application details

Product name:

Gastrozol Gold Oral Paste for Horses

Product number:

96903

Applicant Name:

VIRBAC (AUSTRALIA) PTY LTD

Application purpose and description of use:

Registration of a 240mg/mL esomeprazole oral paste product for horses, in conjunction with approval of active constituent.

Description of data provided:

Data no
307519
Author
Rendle D
Title
Marked Changes
Study date
2025
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
307528
Author
Anon
Title
Safety Data Sheet
Study date
April 2023
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
307522
Author
Virbac
Title
Cover Letter
Study date
29 May 2026
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
307534
Author
Kuroyama M et al
Title
Exogenous lipoid pneumonia caused by repeated pulling: a report of two cases
Study date
2015
Authorising party
Public
Auth party contact address
-
Data no
307525
Author
Anon
Title
Material Safety Data Sheet
Study date
June 2021
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
307531
Author
Anon
Title
Safety Data Sheet
Study date
May 2019
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
307517
Author
B. Romana
Title
Interim Stability Report
Study date
March 2026
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
307526
Author
Anon
Title
Safety Data Sheet
Study date
August 2021
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
307520
Author
Rendle D
Title
Proposed Edits
Study date
May 2026
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
307523
Author
Anon
Title
Material Safety Data Sheet
Study date
November 2021
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
307532
Author
Johnson W et al
Title
Amended Safety Assessment
Study date
2011
Authorising party
Public
Auth party contact address
-
Data no
307518
Author
Anon
Title
RETRACTION: Comparison of Oral Esomeprazole and Oral Omeprazole in the Treatment of Equine Squamous
Gastric Disease
Study date
August 2025
Authorising party
Public
Auth party contact address
-
Data no
307521
Author
Chambers M
Title
Response to APVMA Notice
Study date
May 2026
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
307529
Author
Anon
Title
Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests
Study date
August 2016
Authorising party
Public
Auth party contact address
-
Data no
307535
Author
Department of Health
Title
Chemicals that are unlikely to require further regulation to manage risks to health - Evaluation Statement
Study date
January 2022
Authorising party
Public
Auth party contact address
-
Data no
307524
Author
Anon
Title
Safety Data Sheet
Study date
June 2021
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
307530
Author
Anon
Title
Safety Data Sheet
Study date
June 2020
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
307516
Author
Virbac
Title
Chemistry and Manufacture Summary (B)
Study date
May 2026
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
307527
Author
Anon
Title
Material Safety Data Sheet
Study date
May 2023
Authorising party
Applicant
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
307533
Author
Baker B.P. and Grant J.A.
Title
Profile Active Ingredient Eligible for Minimum Risk Pesticide Use
Study date
2026
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

151244
Product/Active constituent Name

Application Product Name

Surefire Exomite Selective Miticide

Application details

Product name:

Surefire Exomite Selective Miticide

Product number:

93660

Applicant Name:

PCT HOLDINGS PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to include additional uses in grapevines and turf.
Date

Application Date

Application No

Application Number

151299
Product/Active constituent Name

Application Product Name

GENFARM FLONICAMID 500 WG INSECTICIDE

Application details

Product name:

GENFARM FLONICAMID 500 WG INSECTICIDE

Product number:

96937

Applicant Name:

NUTRIEN AG SOLUTIONS LIMITED

Application purpose and description of use:

Registration of a 500 g/kg WG Flonicamid product for the control of aphids and mealybug in apples, pears and nursery stock; for the control of aphids and mirids in cotton; for the control of aphids and silverleaf whitefly in cucurbits; for the control of aphids in potatoes; for the control of whitefly in tomatoes; for the control of aphids, whiteflies and green mirids in strawberries.

Reference details:

66373 - MAINMAN 500 WG INSECTICIDE
Date

Application Date

Application No

Application Number

151461
Product/Active constituent Name

Application Product Name

Serenade Prime Soil Ameliorant and Biofungicide

Application details

Product name:

Serenade Prime Soil Ameliorant and Biofungicide

Product number:

85292

Applicant Name:

BAYER CROPSCIENCE PTY LTD

Application purpose and description of use:

Variation of label approval to include additional uses in grapevines.
Date

Application Date

Application No

Application Number

151641
Product/Active constituent Name

Application Product Name

Owtbac Q-Action Multi-Combination Drench For Sheep

Application details

Product name:

Owtbac Q-Action Multi-Combination Drench For Sheep

Product number:

97052

Applicant Name:

OWTBAC AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 40 g/L levamisole hydrochloride, 37.5 g/L closantel, 25 g/L albendazole and 1.0 g/L abamectin oral drench product for the treatment and control in sheep of susceptible gastrointestinal roundworms, lungworm, tapeworms, mature and late immature liver fluke, nasal bot and itch mite.

Reference details:

56573 - Q-DRENCH MULTI-COMBINATION DRENCH FOR SHEEP
Date

Application Date

Application No

Application Number

151197
Product/Active constituent Name

Application Product Name

Kenja 400 SC Fungicide

Application details

Product name:

Kenja 400 SC Fungicide

Product number:

88495

Applicant Name:

ISHIHARA SANGYO KAISHA, LTD

Application purpose and description of use:

Variation of label approval to add the use on wine grapes.
Date

Application Date

Application No

Application Number

151472
Product/Active constituent Name

Application Product Name

Exirel eVo Insecticide

Application details

Product name:

Exirel eVo Insecticide

Product number:

97000

Applicant Name:

FMC AUSTRALASIA PTY LTD

Application purpose and description of use:

Registration of a suspension concentrate containing 600 g/L of cyantraniliprole for the control of certain insect pests in Canola, Cotton and Forage Brassicas as per the Directions for Use.

Reference details:

64103 - EXIREL INSECTICIDE
Date

Application Date

Application No

Application Number

150984
Product/Active constituent Name

Application Product Name

Albaugh Spiromax 240 SC Insecticide

Application details

Product name:

Albaugh Spiromax 240 SC Insecticide

Product number:

94728

Applicant Name:

ALBAUGH AUSTRALIA PTY LTD

Application purpose and description of use:

Variation of product registration to vary registered particulars.

Reference details:

61864 - MOVENTO 240 SC INSECTICIDE
Date

Application Date

Application No

Application Number

151072
Product/Active constituent Name

Application Product Name

Endurance 500 SC

Application details

Product name:

Endurance 500 SC

Product number:

96879

Applicant Name:

ADAMA AUSTRALIA PTY LIMITED

Application purpose and description of use:

Registration of a 500 g/L Indaziflam Suspension Concentrate (SC) product application for pre-emergence control of various weeds in Sugarcane.