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
151250
Product/Active constituent Name
Application Product Name
Credelio Plus Chewable Tablets for Medium Dogs
Application Date
Application Number
151250
Application Product Name
Credelio Plus Chewable Tablets for Medium Dogs
Application details
Product name:
Credelio Plus Chewable Tablets for Medium Dogs
Product number:
89317
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to extend the use to include the treatment and control of sarcoptes mites.
Active constituents:
Active constituent name
82858 - LOTILANER
Active constituent name
88307 - Lotilaner
Active constituent name
85684 - MILBEMYCIN OXIME
Date
Application Date
Application No
Application Number
151252
Product/Active constituent Name
Application Product Name
Credelio Plus Chewable Tablets for Small Dogs
Application Date
Application Number
151252
Application Product Name
Credelio Plus Chewable Tablets for Small Dogs
Application details
Product name:
Credelio Plus Chewable Tablets for Small Dogs
Product number:
89316
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to extend the use to include the treatment and control of sarcoptes mites.
Active constituents:
Active constituent name
82858 - LOTILANER
Active constituent name
88307 - Lotilaner
Active constituent name
85684 - MILBEMYCIN OXIME
Date
Application Date
Application No
Application Number
151253
Product/Active constituent Name
Application Product Name
Credelio Plus Chewable Tablets for Very Small Dogs
Application Date
Application Number
151253
Application Product Name
Credelio Plus Chewable Tablets for Very Small Dogs
Application details
Product name:
Credelio Plus Chewable Tablets for Very Small Dogs
Product number:
89315
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to extend the use to include the treatment and control of sarcoptes mites.
Active constituents:
Active constituent name
82858 - LOTILANER
Active constituent name
88307 - Lotilaner
Active constituent name
85684 - MILBEMYCIN OXIME
Date
Application Date
Application No
Application Number
151295
Product/Active constituent Name
Application Product Name
SUROLAN SUSPENSION FOR OTITIS EXTERNA AND SKIN INFECTIONS IN DOGS AND CATS
Application Date
Application Number
151295
Application Product Name
SUROLAN SUSPENSION FOR OTITIS EXTERNA AND SKIN INFECTIONS IN DOGS AND CATS
Application details
Product name:
SUROLAN SUSPENSION FOR OTITIS EXTERNA AND SKIN INFECTIONS IN DOGS AND CATS
Product number:
46427
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of product label approval to include in-use statement.
Active constituents:
Active constituent name
83321 - PREDNISOLONE ACETATE
Active constituent name
84995 - POLYMYXIN B SULPHATE
Active constituent name
55840 - MICONAZOLE NITRATE
Description of data provided:
Data no
296851
Title
Stability Development Report SDR227.01
Study date
29 October 2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
296852
Title
Stability Development Report SDR224.01
Study date
29 June 2018
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
151313
Product/Active constituent Name
Application Product Name
Owtbac Spinobeat Pour-On for Sheep
Application Date
Application Number
151313
Application Product Name
Owtbac Spinobeat Pour-On for Sheep
Application details
Product name:
Owtbac Spinobeat Pour-On for Sheep
Applicant Name:
OWTBAC AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 20 g/mL Spinosad Solution for the control of spinosad-susceptible lice (Bovicola ovis), including strains resistant to Synthetic Pyrethroids (SPs), in sheep up to 7 days off-shears and sheep with long wool.
Date
Application Date
Application No
Application Number
151327
Product/Active constituent Name
Application Product Name
AC Hassle Spray Adjuvant
Application Date
Application Number
151327
Application Product Name
AC Hassle Spray Adjuvant
Application details
Product name:
AC Hassle Spray Adjuvant
Applicant Name:
AXICHEM PTY LTD
Application purpose and description of use:
Registration of a emulsifiable concentrate 704 g/L ETHYL and METHYL ESTERS of FATTY ACIDS with 196 g/L Non-ionic Surfactants - an esterified oil based product with non-ionic surfactants to assist the effectiveness of Herbicides and other Agricultural Chemicals
Date
Application Date
Application No
Application Number
151328
Product/Active constituent Name
Application Product Name
Surface Clear Free Floating Aquatic Weed Control
Application Date
Application Number
151328
Application Product Name
Surface Clear Free Floating Aquatic Weed Control
Application details
Product name:
Surface Clear Free Floating Aquatic Weed Control
Applicant Name:
AQUATIC SITE MAINTENANCE PTY LTD
Application purpose and description of use:
Registration of a water miscible liquid formulation of 55.2 g/kg ORANGE OIL and 195 g/kg SURFACTANTS for the control of Salvinia, Red Azolla and Lemna in non-potable water.
Date
Application Date
Application No
Application Number
151332
Product/Active constituent Name
Application Product Name
Genfarm Pyrox 850 WG Herbicide
Application Date
Application Number
151332
Application Product Name
Genfarm Pyrox 850 WG Herbicide
Application details
Product name:
Genfarm Pyrox 850 WG Herbicide
Product number:
91310
Applicant Name:
NUTRIEN AG SOLUTIONS LIMITED
Application purpose and description of use:
Variation to compatibility statement.
Active constituents:
Active constituent name
90545 - Pyroxasulfone
Active constituent name
64067 - PYROXASULFONE
Active constituent name
80051 - Pyroxasulfone
Active constituent name
80847 - Pyroxasulfone
Date
Application Date
Application No
Application Number
151357
Product/Active constituent Name
Application Product Name
PyroSal Pyroxasulfone 850 WG Herbicide
Application Date
Application Number
151357
Application Product Name
PyroSal Pyroxasulfone 850 WG Herbicide
Application details
Product name:
PyroSal Pyroxasulfone 850 WG Herbicide
Applicant Name:
AUSTRALIAN AGVET REGISTRATION SOLUTIONS PTY LTD
Application purpose and description of use:
Registration of a 850 g/kg Pyroxasulfone water dispersible granule (WG) 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), Triticale and Certain Winter Legume Crops
Date
Application Date
Application No
Application Number
151454
Product/Active constituent Name
Application Product Name
Quantum Epoxiconazole 125 SC Fungicide
Application Date
Application Number
151454
Application Product Name
Quantum Epoxiconazole 125 SC Fungicide
Application details
Product name:
Quantum Epoxiconazole 125 SC Fungicide
Product number:
94897
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Variation of product registration Quantum Epoxiconazole 125 SC Fungicide (APVMA No.94897) and label approval to add
a new pack size (1000L) and packaging material (HDPE)
Active constituents:
Active constituent name
90197 - EPOXICONAZOLE
Date
Application Date
Application No
Application Number
151455
Product/Active constituent Name
Application Product Name
QA Azoxystrobin 250 SC Fungicide
Application Date
Application Number
151455
Application Product Name
QA Azoxystrobin 250 SC Fungicide
Application details
Product name:
QA Azoxystrobin 250 SC Fungicide
Product number:
92097
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Variation of product registration QA Azoxystrobin 250 SC Fungicide (APVMA No.92097) and label approval to add a new pack size (1000L) and packaging material (HDPE)
Active constituents:
Active constituent name
64692 - AZOXYSTROBIN
Date
Application Date
Application No
Application Number
151142
Product/Active constituent Name
Application Product Name
Nufarm Sempra Herbicide
Application Date
Application Number
151142
Application Product Name
Nufarm Sempra Herbicide
Application details
Product name:
Nufarm Sempra Herbicide
Product number:
56620
Applicant Name:
NUFARM AUSTRALIA LIMITED
Application purpose and description of use:
Variation of label approval to change the recommended adjuvants and change of a term in the General Instructions.
Reference details:
89989 - Cando Concentrate Spray Adjuvant
89989 - Nufarm Cando Adjuvant
89989 - Nufarm Cando Concentrate Adjuvant
89989 - Nufarm Cando Concentrate Spray Adjuvant
Active constituents:
Active constituent name
46051 - HALOSULFURON-METHYL
Description of data provided:
Data no
299648
Title
Nufarm Sempra Herbicide Marked Up Label
Study date
25 November 2025
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
299651
Title
89989_126666 CANDO SPRAY ADJUVANT FTR for release
Study date
13 April 2021
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
299649
Title
Nufarm Sempra Herbicide Label Clean
Study date
25 November 2025
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
299650
Title
86703_116413 - NUL3279 Efficacy FTR Applicant Copy
Study date
14 January 2019
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Date
Application Date
Application No
Application Number
151445
Product/Active constituent Name
Application Product Name
Bainbridge Bait Blocks Rodenticide
Application Date
Application Number
151445
Application Product Name
Bainbridge Bait Blocks Rodenticide
Application details
Product name:
Bainbridge Bait Blocks Rodenticide
Product number:
87657
Applicant Name:
BAINBRIDGE PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to vary the formulation, add packs and vary the Relevant Label Particulars.
Active constituents:
Active constituent name
56139 - BRODIFACOUM
Description of data provided:
Data no
299771
Title
Email from Kate Shearston
Study date
19 December 2025
Auth party contact address
26 Avatonbell Drive Luscombe Australia
Data no
299772
Title
Formulation details
Study date
19 December 2025
Auth party contact address
408 HEADS ROAD, WHANGANUI 4501, New Zealand
Data no
299770
Title
Consent for Use of Confidential Commercial Information and Protected Information
Study date
19 December 2025
Auth party contact address
26 Avatonbell Drive Luscombe Australia
Date
Application Date
Application No
Application Number
151243
Product/Active constituent Name
Application Product Name
Credelio Plus Chewable Tablets for Very Large Dogs
Application Date
Application Number
151243
Application Product Name
Credelio Plus Chewable Tablets for Very Large Dogs
Application details
Product name:
Credelio Plus Chewable Tablets for Very Large Dogs
Product number:
89319
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to extend the use to include the treatment and control of sarcoptes mites.
Active constituents:
Active constituent name
82858 - LOTILANER
Active constituent name
88307 - Lotilaner
Active constituent name
85684 - MILBEMYCIN OXIME
Description of data provided:
Data no
296582
Title
ELA221330 Report Amendment
Study date
15 APR 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
296599
Title
Treatment of canine scabies with milbemycin oxime.
Study date
1996
Auth party contact address
-
Data no
296602
Title
Antiparasitics in animal health: quo vadis?
Study date
2021
Auth party contact address
-
Data no
296585
Title
A review of Sarcoptes scabiei: past, present and future.
Study date
2017
Auth party contact address
-
Data no
296596
Title
Treatment of canine sarcoptic mange with afoxolaner (NexGard) and afoxolaner plus milbemycin oxime (NexGard Spectra) chewable tablets: efficacy under field conditions in Portugal and Germany.
Study date
2018
Auth party contact address
-
Data no
296593
Title
Efficacy and safety of a novel oral isoxazoline, sarolaner (Simparica), for the treatment of sarcoptic mange in dogs
Study date
2016
Auth party contact address
-
Data no
296580
Title
Part 8 Overview
Study date
01 DEC 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
296588
Title
Expanded Molecular Typing of Sarcoptes scabiei Provides Further Evidence of Disease Spillover Events in the Epidemiology of Sarcoptic Mange in Australian Marsupials.
Study date
2019
Auth party contact address
-
Data no
296597
Title
Clinical, parasitological, and serological follow-up of dogs with sarcoptic mange treated orally with lotilaner
Study date
2021
Auth party contact address
-
Data no
296594
Title
Efficacy of afoxolaner in a clinical field study in dogs naturally infested with Sarcoptes scabiei.
Study date
2016
Auth party contact address
-
Data no
296600
Title
Treatment of canine sarcoptic mange using milbemycin oxime
Study date
1995
Auth party contact address
-
Data no
296591
Title
Epizootiology of sarcoptic mange in buffalo calves.
Study date
2003
Auth party contact address
-
Data no
296586
Title
Genetic epidemiology of Sarcoptes scabiei (Acari: Sarcoptidae) in northern Australia
Study date
2004
Auth party contact address
-
Data no
296592
Title
Efficacy of afoxolaner plus milbemycin oxime and afoxolaner alone as treatment for sarcoptic mange in naturally infested dogs.
Study date
2020
Auth party contact address
-
Data no
296583
Title
ELA221036 Field study of natural infestation with Sarcoptes scabiei in dogs
Study date
27 May 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
296598
Title
The most effective systemic treatment in dogs with sarcoptic mange: a critically appraised topic.
Study date
2023
Auth party contact address
-
Data no
296589
Title
Molecular detection and characterization of Sarcoptes scabiei var. canis using skin scrapings and skin biopsies.
Study date
2020
Auth party contact address
-
Data no
296595
Title
Efficacy of orally and topically administered fluralaner (Bravecto) for treatment of client-owned dogs with sarcoptic mange under field conditions.
Study date
2020
Auth party contact address
-
Data no
296584
Title
Justification letter
Study date
Nov 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
296601
Title
Diagnosis and treatment of demodicosis in dogs and cats. Clinical Consensus Guidelines of the World Association for Veterinary Dermatology.
Study date
2020
Auth party contact address
-
Data no
296590
Title
Efficacy of fluralaner administered either orally or topically for the treatment of naturally acquired Sarcoptes scabiei var. canis infestation in dogs.
Study date
2016
Auth party contact address
-
Data no
296581
Title
ELA221330 Dose confirmation study of natural infestation with Sarcoptes scabiei in dogs
Study date
11 Dec 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
296587
Title
Mitochondrial genome sequencing reveals potential origins of the scabies mite Sarcoptes scabiei infesting two iconic Australian marsupials
Study date
2017
Auth party contact address
-
Date
Application Date
Application No
Application Number
151433
Product/Active constituent Name
Application Product Name
Ilunocitinib
Application Date
Application Number
151433
Application Product Name
Ilunocitinib
Application details
Product name:
Ilunocitinib
Active name:
Ilunocitinib
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Approval of a new manufacturing source for an existing API.
Description of data provided:
Data no
298411
Title
3.2.S.2.4 Control of Critical Steps and Intermediates
Study date
October 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
298409
Title
3.2.S.2.1 DS Manufacturer
Study date
December 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
298412
Title
3.2.S.4.1 DS Specification
Study date
July 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
298413
Title
Batch Analysis
Study date
September 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
298410
Title
3.2.S.2.2 Description of Manufacturing Process and Process controls
Study date
October 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
151115
Product/Active constituent Name
Application Product Name
Tebuthiuron
Application Date
Application Number
151115
Application Product Name
Tebuthiuron
Application details
Product name:
Tebuthiuron
Active name:
Tebuthiuron
Applicant Name:
Hebei Lansheng Biotech Co Ltd
Application purpose and description of use:
Approval of Tebuthiuron for use in agricultural chemical products.
Description of data provided:
Data no
299430
Title
Statement of 5 Batch Size and typical batch size of Tebuthiuron Technical
Study date
October 2025
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Data no
299427
Title
Manufacturing process and impurities formation description of Tebuthiuron Technical
Study date
November 2025
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Data no
299428
Title
Declaration of Composition(DoC)
Study date
October 2025
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Data no
299426
Title
Determination of Active Content and Impurity Profile of Tebuthiuron Technical
Study date
August 2025
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Data no
299429
Title
Available packages for Tebuthiuron TC
Study date
October 2025
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Date
Application Date
Application No
Application Number
151311
Product/Active constituent Name
Application Product Name
COOPERS PERMATRACE 3 YEAR SELENIUM PELLETS FOR SHEEP
Application Date
Application Number
151311
Application Product Name
COOPERS PERMATRACE 3 YEAR SELENIUM PELLETS FOR SHEEP
Application details
Product name:
COOPERS PERMATRACE 3 YEAR SELENIUM PELLETS FOR SHEEP
Product number:
47639
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of label approval to update the product RLP.
Active constituents:
Active constituent name
85569 - SELENIUM
Description of data provided:
Data no
296882
Title
General Directions
Study date
December 2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
151359
Product/Active constituent Name
Application Product Name
COOPERS PERMATRACE 3 YEAR COBALT PELLETS FOR SHEEP
Application Date
Application Number
151359
Application Product Name
COOPERS PERMATRACE 3 YEAR COBALT PELLETS FOR SHEEP
Application details
Product name:
COOPERS PERMATRACE 3 YEAR COBALT PELLETS FOR SHEEP
Product number:
47611
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of label approval to update the product RLP.
Description of data provided:
Data no
297114
Title
General Directions
Study date
December 2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
151361
Product/Active constituent Name
Application Product Name
COOPERS PERMATRACE SELENIUM PELLETS FOR CATTLE
Application Date
Application Number
151361
Application Product Name
COOPERS PERMATRACE SELENIUM PELLETS FOR CATTLE
Application details
Product name:
COOPERS PERMATRACE SELENIUM PELLETS FOR CATTLE
Product number:
47640
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of label approval to update the product RLP.
Active constituents:
Active constituent name
84482 - POTASSIUM PHOSPHATE MONOBASIC
Active constituent name
85569 - SELENIUM
Description of data provided:
Data no
297123
Title
General Directions
Study date
December 2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
151364
Product/Active constituent Name
Application Product Name
COOPERS PERMATRACE COBALT PELLETS FOR CATTLE
Application Date
Application Number
151364
Application Product Name
COOPERS PERMATRACE COBALT PELLETS FOR CATTLE
Application details
Product name:
COOPERS PERMATRACE COBALT PELLETS FOR CATTLE
Product number:
47638
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of label approval to update the product RLP.
Active constituents:
Active constituent name
55409 - COBALT OXIDE
Description of data provided:
Data no
297125
Title
General Directions
Study date
December 2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia