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

151115
Product/Active constituent Name

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
Author
P Chen
Title
Statement of 5 Batch Size and typical batch size of Tebuthiuron Technical
Study date
October 2025
Authorising party
Applicant
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Data no
299427
Author
P Chen
Title
Manufacturing process and impurities formation description of Tebuthiuron Technical
Study date
November 2025
Authorising party
Applicant
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Data no
299428
Author
P Chen
Title
Declaration of Composition(DoC)
Study date
October 2025
Authorising party
Applicant
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Data no
299426
Author
V Damnjanovic
Title
Determination of Active Content and Impurity Profile of Tebuthiuron Technical
Study date
August 2025
Authorising party
Applicant
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Data no
299429
Author
P Chen
Title
Available packages for Tebuthiuron TC
Study date
October 2025
Authorising party
Applicant
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Date

Application Date

Application No

Application Number

151142
Product/Active constituent Name

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
Author
M Holland
Title
Nufarm Sempra Herbicide Marked Up Label
Study date
25 November 2025
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
299651
Author
APVMA
Title
89989_126666 CANDO SPRAY ADJUVANT FTR for release
Study date
13 April 2021
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
299649
Author
M Holland
Title
Nufarm Sempra Herbicide Label Clean
Study date
25 November 2025
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
299650
Author
APVMA
Title
86703_116413 - NUL3279 Efficacy FTR Applicant Copy
Study date
14 January 2019
Authorising party
Applicant
Auth party contact address
103-105 PIPE RD LAVERTON NORTH 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 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
Author
Elanco
Title
ELA221330 Report Amendment
Study date
15 APR 2025
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
296599
Author
Miller WH Jr, de Jaham C, Scott DW, Cayatte SM, Bagladi MS, Buerger RG.
Title
Treatment of canine scabies with milbemycin oxime.
Study date
1996
Authorising party
Public
Auth party contact address
-
Data no
296602
Author
Selzer PM, Epe C.
Title
Antiparasitics in animal health: quo vadis?
Study date
2021
Authorising party
Public
Auth party contact address
-
Data no
296585
Author
Appendix 8-3 Ref 1. Arlian LG, Morgan MS.
Title
A review of Sarcoptes scabiei: past, present and future.
Study date
2017
Authorising party
Public
Auth party contact address
-
Data no
296596
Author
Hampel V, Knaus M, Schafer J, Beugnet F, Rehbein S.
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
Authorising party
Public
Auth party contact address
-
Data no
296593
Author
Becskei C, De Bock F, Illambas J, Cherni JA, Fourie JJ, Lane M, et al.
Title
Efficacy and safety of a novel oral isoxazoline, sarolaner (Simparica), for the treatment of sarcoptic mange in dogs
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
296580
Author
Elanco
Title
Part 8 Overview
Study date
01 DEC 2025
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
296588
Author
Fraser TA, et al
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
Authorising party
Public
Auth party contact address
-
Data no
296597
Author
Moog F, Brun J, Bourdeau P, Cadiergues MC.
Title
Clinical, parasitological, and serological follow-up of dogs with sarcoptic mange treated orally with lotilaner
Study date
2021
Authorising party
Public
Auth party contact address
-
Data no
296594
Author
Beugnet F, de Vos C, Liebenberg J, Halos L, Larsen D, Fourie J.
Title
Efficacy of afoxolaner in a clinical field study in dogs naturally infested with Sarcoptes scabiei.
Study date
2016
Authorising party
Public
Auth party contact address
-
Data no
296600
Author
de Jaham C, Henry CJ.
Title
Treatment of canine sarcoptic mange using milbemycin oxime
Study date
1995
Authorising party
Public
Auth party contact address
-
Data no
296591
Author
Patel JS, Patel PR, Panchasara HH, Brahmaxatri KG
Title
Epizootiology of sarcoptic mange in buffalo calves.
Study date
2003
Authorising party
Public
Auth party contact address
-
Data no
296586
Author
Walton SF, Dougall A, Pizzutto S, Holt D, Taplin D, Arlian LG, Morgan M, Currie BJ, Kemp DJ.
Title
Genetic epidemiology of Sarcoptes scabiei (Acari: Sarcoptidae) in northern Australia
Study date
2004
Authorising party
Public
Auth party contact address
-
Data no
296592
Author
Romero-Nunez C, Bautista-Gomez LG, Sheinberg G, Martin-Cordero A, Flores-Ortega A, Heredia-Cardenas R
Title
Efficacy of afoxolaner plus milbemycin oxime and afoxolaner alone as treatment for sarcoptic mange in naturally infested dogs.
Study date
2020
Authorising party
Public
Auth party contact address
-
Data no
296583
Author
Elanco
Title
ELA221036 Field study of natural infestation with Sarcoptes scabiei in dogs
Study date
27 May 2025
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
296598
Author
Dumitrache MO, Cadiergues M-C
Title
The most effective systemic treatment in dogs with sarcoptic mange: a critically appraised topic.
Study date
2023
Authorising party
Public
Auth party contact address
-
Data no
296589
Author
Nwufoh OC, Sadiq NA, Fagbohun O, Adebiyi A, Adeshina R, Ekeanyanwu E, Emikpe BO.
Title
Molecular detection and characterization of Sarcoptes scabiei var. canis using skin scrapings and skin biopsies.
Study date
2020
Authorising party
Public
Auth party contact address
-
Data no
296595
Author
Chiummo R, Petersen I, Plehn C, Zschiesche E, Roepke R, Thomas E.
Title
Efficacy of orally and topically administered fluralaner (Bravecto) for treatment of client-owned dogs with sarcoptic mange under field conditions.
Study date
2020
Authorising party
Public
Auth party contact address
-
Data no
296584
Author
Elanco
Title
Justification letter
Study date
Nov 2025
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
296601
Author
Mueller RS, Rosenkrantz W, Bensignor E, Karas-Tecza J, Paterson T, Shipstone MA.
Title
Diagnosis and treatment of demodicosis in dogs and cats. Clinical Consensus Guidelines of the World Association for Veterinary Dermatology.
Study date
2020
Authorising party
Public
Auth party contact address
-
Data no
296590
Author
Taenzler J, Liebenberg J, Roepke RKA, Frenais R, Heckeroth AR.
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
Authorising party
Public
Auth party contact address
-
Data no
296581
Author
Elanco
Title
ELA221330 Dose confirmation study of natural infestation with Sarcoptes scabiei in dogs
Study date
11 Dec 2024
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
296587
Author
Fraser TA, et al.
Title
Mitochondrial genome sequencing reveals potential origins of the scabies mite Sarcoptes scabiei infesting two iconic Australian marsupials
Study date
2017
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

151433
Product/Active constituent Name

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
Author
Elanco Animal Health
Title
3.2.S.2.4 Control of Critical Steps and Intermediates
Study date
October 2025
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
298409
Author
Elanco Animal Health
Title
3.2.S.2.1 DS Manufacturer
Study date
December 2025
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
298412
Author
Elanco Animal Health
Title
3.2.S.4.1 DS Specification
Study date
July 2025
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
298413
Author
Elanco Animal Health
Title
Batch Analysis
Study date
September 2025
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
298410
Author
Elanco Animal Health
Title
3.2.S.2.2 Description of Manufacturing Process and Process controls
Study date
October 2025
Authorising party
Applicant
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

151445
Product/Active constituent Name

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
Author
APVMA
Title
Email from Kate Shearston
Study date
19 December 2025
Authorising party
Applicant
Auth party contact address
26 Avatonbell Drive Luscombe Australia
Data no
299772
Author
Anon
Title
Formulation details
Study date
19 December 2025
Authorising party
Animal Control Products Ltd
Auth party contact address
408 HEADS ROAD, WHANGANUI 4501, New Zealand
Data no
299770
Author
Anon
Title
Consent for Use of Confidential Commercial Information and Protected Information
Study date
19 December 2025
Authorising party
Applicant
Auth party contact address
26 Avatonbell Drive Luscombe Australia
Date

Application Date

Application No

Application Number

151357
Product/Active constituent Name

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

151313
Product/Active constituent Name

Application Product Name

Owtbac Spinoprob Pour-On for Sheep

Application details

Product name:

Owtbac Spinoprob 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

150526
Product/Active constituent Name

Application Product Name

LUNA SENSATION FUNGICIDE

Application details

Product name:

LUNA SENSATION FUNGICIDE

Product number:

65560

Applicant Name:

BAYER CROPSCIENCE PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to amend the plant back interval.

Active constituents:

Active constituent name
63735 - FLUOPYRAM
Active constituent name
54241 - TRIFLOXYSTROBIN
Active constituent name
90823 - Fluopyram

Description of data provided:

Data no
299496
Author
APVMA
Title
Residues and trade evaluation report - Luna Experience Fungicide.
Study date
May 2025
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299497
Author
Braune, M.
Title
Determination of the residues of BCS-CS55621 and AE C656948 in/on field rotational crop corn after spray application of BCS-CS55621 SC 020 and Fluopyram SC 250 to bare soil in the Netherlands, Germany, southern France and Spain.
Study date
24/6/22
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299498
Author
Braune, M.
Title
Determination of the residues of BCS-CS55621 and AE C656948 in/on field rotational crop pea and soil after spray application of BCS-CS55621 SC 020 and Fluopyram SC 250 to bare soil in Belgium, Germany, southern France and Spain.
Study date
21/6/22
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299499
Author
Braune, M.
Title
Determination of the residues of BCS-CS55621 and AE C656948 in/on field rotational crop spring wheat and soil after spray application of BCS-CS55621 SC 020 and Fluopyram SC 250 to bare soil in Germany and northern France.
Study date
6/9/23
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299500
Author
Braune, M. & Stolpe, C.
Title
Determination of the residues of BCS-CS55621 and AE C656948 in/on field rotational crop wheat and soil after spray application of BCS-CS55621 SC 020 and Fluopyram SC 250 to bare soil in Spain and southern France.
Study date
22/9/22
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299501
Author
Moon, C.
Title
Determination of fluopyram in plant back crops following the application of a fluopyram containing product to bare earth several months prior to planting.
Study date
27/6/22
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
299502
Author
Swifka, J. & Stolpe, C.
Title
Determination of the residues of BCS-CS55621 and AE C656948 in/on field rotational crop rape and soil after spray application of BCS-CS55621 SC 020 and Fluopyram SC 250 to bare soil in the Netherlands, Belgium, southern France and Spain.
Study date
28/7/22
Authorising party
Applicant
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Date

Application Date

Application No

Application Number

151041
Product/Active constituent Name

Application Product Name

ACP Flumiox 500 Herbicide

Application details

Product name:

ACP Flumiox 500 Herbicide

Product number:

96876

Applicant Name:

AUSTRALIS CROP PROTECTION PTY LTD

Application purpose and description of use:

Re-registration of a 500g/kg Flumioxazin, water dispersible granule product for knockdown and residual control of broadleaf weeds and grasses in a range of broadacre crops, and in non-crop situations, as specified in the DIRECTIONS FOR USE table.

Reference details:

82740 - Flumin 500 Dry Herbicide

Description of data provided:

Data no
298826
Author
Rainbow
Title
2 4 ACP Flumiox 500 Herbicide Manufacturer's Declaration
Study date
22 January 2024
Authorising party
Applicant
Auth party contact address
SHOP 4, 30 HEBER STREET MOREE Australia
Date

Application Date

Application No

Application Number

151311
Product/Active constituent Name

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
Author
Anon
Title
General Directions
Study date
December 2025
Authorising party
Applicant
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 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
Author
Anon
Title
General Directions
Study date
December 2025
Authorising party
Applicant
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 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
Author
Anon
Title
General Directions
Study date
December 2025
Authorising party
Applicant
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 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
Author
Anon
Title
General Directions
Study date
December 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date

Application Date

Application No

Application Number

151368
Product/Active constituent Name

Application Product Name

COOPERS PERMATRACE COPPER 20 CAPSULES FOR CATTLE

Application details

Product name:

COOPERS PERMATRACE COPPER 20 CAPSULES FOR CATTLE

Product number:

47688

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
297136
Author
Anon
Title
General Directions
Study date
December 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date

Application Date

Application No

Application Number

151369
Product/Active constituent Name

Application Product Name

COOPERS PERMATRACE COPPER CAPSULES FOR ADULT SHEEP & GOATS

Application details

Product name:

COOPERS PERMATRACE COPPER CAPSULES FOR ADULT SHEEP & GOATS

Product number:

47637

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
297138
Author
Anon
Title
General Directions
Study date
December 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date

Application Date

Application No

Application Number

151370
Product/Active constituent Name

Application Product Name

COOPERS PERMATRACE COPPER 10 CAPSULES FOR CALVES AND ADULT CATTLE

Application details

Product name:

COOPERS PERMATRACE COPPER 10 CAPSULES FOR CALVES AND ADULT CATTLE

Product number:

47689

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
55090 - OXYFLUORFEN
Active constituent name
54781 - OXYFLUORFEN
Active constituent name
56611 - OXYFLUORFEN

Description of data provided:

Data no
297188
Author
Anon
Title
General Directions
Study date
December 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date

Application Date

Application No

Application Number

151013
Product/Active constituent Name

Application Product Name

eFUME FUMIGANT

Application details

Product name:

eFUME FUMIGANT

Product number:

88523

Applicant Name:

DRASLOVKA SERVICES PTY LTD

Application purpose and description of use:

This is an item 12 application. The application seeks to vary the label of eFUME FUMIGANT (Product No. 88523) to add Pelletised processed animal feed (stock feed) to the list of approved commodities/situations. The proposed label extension is to include animal feed products

Description of data provided:

Data no
298820
Author
J. M Desmarchelier
Title
Ethyl formate and formic acid occurence and environmental fate
Study date
1999
Authorising party
Applicant
Auth party contact address
15-17 Second Avenue Sunshine Australia
Data no
298821
Author
GATE WAY MILLING
Title
eFUME supporting letter for animal feed approval
Study date
2025
Authorising party
Applicant
Auth party contact address
15-17 Second Avenue Sunshine Australia
Data no
298815
Author
Melissa Marino and Sue Knights
Title
Pest resistance raisining the knowledge bar for stored grain
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
298818
Author
US EPA
Title
USEPA Ethyl formate tolerance exemption
Study date
2025
Authorising party
Applicant
Auth party contact address
15-17 Second Avenue Sunshine Australia
Data no
298816
Author
Safe Work Australia
Title
Changes to Workplace Exposure Limits
Study date
2025
Authorising party
Public
Auth party contact address
-
Data no
298819
Author
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION
Title
Ethyl formate as food flavouring substance EU regulation
Study date
2008
Authorising party
Applicant
Auth party contact address
15-17 Second Avenue Sunshine Australia
Data no
298814
Author
Australian Government
Title
Australia???s 2030 Emissions Reduction Target
Study date
2015
Authorising party
Public
Auth party contact address
-
Data no
298817
Author
US Food and Drug Adminstration
Title
USFDA GRAS
Study date
1976
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

151109
Product/Active constituent Name

Application Product Name

VAXSAFE IB VACCINE (LIVING)

Application details

Product name:

VAXSAFE IB VACCINE (LIVING)

Product number:

55222

Applicant Name:

BIOPROPERTIES PTY. LTD.

Application purpose and description of use:

Variation of product registration to extend the registered shelf life.

Active constituents:

Active constituent name
57286 - INFECTIOUS BRONCHITIS VIRUS (INGHAM STRAIN) - LIVE

Description of data provided:

Data no
295847
Author
Bioproperties
Title
Executive Summary
Study date
November 2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
295848
Author
Bioproperties Pty Ltd
Title
Vaxsafe IB (1,000 dose and 10,000 dose) Long Term Stability Study to extend shelf life when filled in 10 mL vials
Study date
November 2025
Authorising party
Applicant
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Date

Application Date

Application No

Application Number

151128
Product/Active constituent Name

Application Product Name

CANINSULIN INSULIN FOR DOGS AND CATS

Application details

Product name:

CANINSULIN INSULIN FOR DOGS AND CATS

Product number:

37255

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Variation of product registration and label approval to formulation, product manufacturers, finished product specifications, manufacturing process and in-process testing.

Active constituents:

Active constituent name
82533 - CHORIONIC GONADOTROPHIN
Active constituent name
83555 - INSULIN, PORCINE

Description of data provided:

Data no
296124
Author
Anon
Title
Present and proposed formulation
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
296121
Author
Anon.
Title
In-use stability study for aged batches
Study date
2019
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
296127
Author
Anon
Title
GMP Certificate site GBA
Study date
2024
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
296122
Author
Anon
Title
In-use stability study for fresh batches
Study date
2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
296130
Author
Anon
Title
Finished product specifications
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
296119
Author
Anon.
Title
Cover Letter for application
Study date
November 2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
296131
Author
Anon
Title
Finished product Batch analysis
Study date
2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
296128
Author
Anon
Title
GMP Certificate LB LS site
Study date
2022
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
296125
Author
European pharmacopoeia
Title
Preservative monograph
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
296129
Author
Anon
Title
Present and Proposed manufacturing process
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
296120
Author
Anon.
Title
Justification for change preservative
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
296126
Author
Anon
Title
Preservative batch analysis
Study date
2021
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
296132
Author
Anon
Title
Caninsulin AQIS permit
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
296123
Author
Anon
Title
Summary of stability report
Study date
2025
Authorising party
Applicant
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date

Application Date

Application No

Application Number

151139
Product/Active constituent Name

Application Product Name

WYNCA PINOXADEN 100EC HERBICIDE

Application details

Product name:

WYNCA PINOXADEN 100EC HERBICIDE

Product number:

93370

Applicant Name:

ZHEJIANG XINAN CHEMICAL INDUSTRIAL GROUP CO., LTD

Application purpose and description of use:

Variation of product registration and label approval due to revised formulation.

Active constituents:

Active constituent name
90347 - Pinoxaden
Active constituent name
87988 - Cloquintocet-mexyl

Description of data provided:

Data no
299545
Author
ZHEJIANG XINAN CHEMICAL INDUSTRIAL GROUP CO., LTD
Title
Manufacturer's Declaration
Study date
2025
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
299546
Author
ZHEJIANG XINAN CHEMICAL INDUSTRIAL GROUP CO., LTD
Title
Wynca Pinoxaden 100EC Formulation Recipe
Study date
2025
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
299547
Author
ZHEJIANG XINAN CHEMICAL INDUSTRIAL GROUP CO., LTD
Title
Wynca Pinoxaden 100EC Formulation COA
Study date
2025
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China
Data no
299544
Author
ZHEJIANG XINAN CHEMICAL INDUSTRIAL GROUP CO., LTD
Title
Executive Summary
Study date
2025
Authorising party
Applicant
Auth party contact address
NO. 93 DAQIAO RD XINANJIANG Jiande China