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
151073
Product/Active constituent Name
Application Product Name
DINOTEFURAN
Application Date
Application Number
151073
Application Product Name
DINOTEFURAN
Application details
Product name:
DINOTEFURAN
Active name:
DINOTEFURAN
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of DINOTEFURAN for use in agricultural chemical products.
Description of data provided:
Data no
299413
Title
Analysis Method - Dinotefuran
Study date
2026
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299416
Title
Certificate of Analysis (CoA) - Dinotefuran Tech Commercial Batches
Study date
Oct 2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299411
Title
PART 1 - EXECUTIVE SUMMARY; PART 2 - CHEMISTRY & MANUFACTURE SUMMARY
Study date
24/11/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299417
Title
MSDS for Dinotefuran
Study date
27/10/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299414
Title
Declaration of Composition (DoC) - Fenitrothion
Study date
4/09/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299415
Title
Five Batch Analysis Report - DinotefuranTechnical - Study No. 0357 (343 pages) along with Amendment No. 01 (36 pages)
Study date
20/01/2022
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299412
Title
Method of Manufacture - Dinotefuran Technical
Study date
September 2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299418
Title
Letter of Support / Authorisation from Source - Dinotefuran Technical
Study date
4/09/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date
Application Date
Application No
Application Number
151075
Product/Active constituent Name
Application Product Name
CHLORTETRACYCLINE HYDROCHLORIDE AS CALCIUM COMPLEX
Application Date
Application Number
151075
Application Product Name
CHLORTETRACYCLINE HYDROCHLORIDE AS CALCIUM COMPLEX
Application details
Product name:
CHLORTETRACYCLINE HYDROCHLORIDE AS CALCIUM COMPLEX
Active name:
CHLORTETRACYCLINE HYDROCHLORIDE AS CALCIUM COMPLEX
Applicant Name:
J H VETERINARY PTY LTD
Application purpose and description of use:
Approval of chlortetracycline hydrochloride as calcium complex for use in veterinary chemical products.
Description of data provided:
Data no
295818
Title
Determination of CTC Content, Minor Components and Impurity Components
Study date
2025
Data no
295819
Title
Validation report of HPLC method for Chlortetracycline
Study date
23 Nov 2015
Data no
299984
Title
Registration File for Chlortetracycline Hydrochloride as Calcium Complex
Study date
December 2025
Auth party contact address
1923/199 William St MELBOURNE Australia
Data no
295820
Title
Current Good Manufacturing Practice Certificate (CGMP)
Study date
9 Sep 2023
Data no
295817
Title
Analysis report of CTC
Study date
9 Nov 2025
Date
Application Date
Application No
Application Number
151079
Product/Active constituent Name
Application Product Name
Vetsense Flygon Gold Insecticidal and Repellent Spray For Horses
Application Date
Application Number
151079
Application Product Name
Vetsense Flygon Gold Insecticidal and Repellent Spray For Horses
Application details
Product name:
Vetsense Flygon Gold Insecticidal and Repellent Spray For Horses
Product number:
92425
Applicant Name:
VETSENSE PTY LTD
Application purpose and description of use:
The purpose of this application is to extend the insecticidal and repellent claims for Flygon Gold to a new Target Animal Species – dogs, following topical application.
Reference details:
36713 - DERMCARE PERMOXIN INSECTICIDAL SPRAY AND RINSE CONCENTRATE FOR DOGS AND HORSES
37422 - FIDO'S CLOSASOLE 10KG BROADSPECTRUM WORMER FOR DOGS & CATS
37433 - FIDO'S FRE-ITCH RINSE CONCENTRATE FOR DOGS, CATS, PUPPIES, KITTENS AND CAGE BIRDS
39670 - TROY FLY REPELLA CREAM
40142 - JOSEPH LYDDY N-DEM INSECTICIDAL LOTION
46258 - ECTOSOOTHE FLEA SHAMPOO FOR DOGS WITH SENSITIVE SKIN
46367 - DI-FLEA INSECTICIDAL SHAMPOO FOR PUPPIES AND KITTENS
46728 - ARISTOPET ANIMAL HEALTH TEA TREE FLEA AND TICK SHAMPOO FOR DOGS AND PUPPIES
51361 - YOURS DROOLLY FLEA & TICK SHAMPOO AND CONDITIONER FOR DOGS & PUPPIES
52709 - EXETICK TICK AND FLEA SPOT-ON FOR DOGS AND PUPPIES
61403 - PURINA TOTALCARE FLEA CONTROL KILLS FLEAS (CTENOCEPHALIDES SPP.)
61403 - PURINA TOTALCARE FLEA CONTROL KILLS FLEAS (CTENOCEPHALIDES SPP.) SHAMPOO FOR DOGS
Active constituents:
Active constituent name
65954 - PIPERONYL BUTOXIDE
Active constituent name
86021 - PERMETRIN (25:75 CIS:TRANS)
Description of data provided:
Data no
295838
Title
Report 24/2253C: Report of testing Vetsense Flygon Gold as a nuisance fly repellent for application to domestic canines.
Study date
21 October 2024
Auth party contact address
1/36 CURTIS ROAD MULGRAVE Australia
Data no
295846
Title
Pyrethroid insecticides maintain repellent effect on knock-down resistant populations of Aedes aegypti mosquitoes
Study date
2018
Auth party contact address
1/36 CURTIS ROAD MULGRAVE Australia
Data no
295841
Title
Repellent and insecticidal efficacy of a new combination of fipronil and permethrin against three mosquito species (Aedes albopictus, Aedes aegypti and Culex pipiens) on dogs
Study date
2015
Auth party contact address
-
Data no
296302
Title
92425_151079 Part 8 Efficacy and Safety Nov 2025
Study date
November 2025
Auth party contact address
1/36 CURTIS ROAD MULGRAVE Australia
Data no
295844
Title
A dual-target molecular mechanism of pyrethrum repellency against mosquitoes
Study date
2021
Auth party contact address
-
Data no
295845
Title
Pyrethrins elicit olfactory response and spatial repellency in Aedes albopictus
Study date
2020
Auth party contact address
1/36 CURTIS ROAD MULGRAVE Australia
Data no
295836
Title
Report 24/2253: Report of testing Vetsense Flygon Gold as a mosquito repellent for application to domestic canines.
Study date
3 July 2024
Auth party contact address
1/36 CURTIS ROAD MULGRAVE Australia
Data no
295842
Title
Repellent and insecticidal efficacy of a new combination of fipronil and permethrin against stable flies (Stomoxys calcitrans).
Study date
2015
Auth party contact address
-
Data no
295839
Title
Report 24/2253D: Report of testing Vetsense Flygon Gold as a flying insect repellent for application to domestic canines.
Study date
3 March 2025
Auth party contact address
1/36 CURTIS ROAD MULGRAVE Australia
Data no
295843
Title
Repellency and Efficacy of a 65% Permethrin Spot-on Formulation for Dogs Against Aedes aegypti (Diptera: Culicidae) Mosquitoes
Study date
2003
Auth party contact address
-
Data no
295840
Title
Repellent and insecticidal efficacy of a combination of dinotefuran, pyriproxyfen and permethrin (Vectra 3D) against Culex pipiens in dogs
Study date
2016
Auth party contact address
-
Data no
296301
Title
92425_151079 Rationale for Choice of Reference Products
Study date
29 Nov 2025
Auth party contact address
1/36 CURTIS ROAD MULGRAVE Australia
Data no
295837
Title
Report 24/2253B: Report of testing Vetsense Flygon Gold as a stable fly repellent for application to domestic canines.
Study date
29 August 2024
Auth party contact address
1/36 CURTIS ROAD MULGRAVE Australia
Date
Application Date
Application No
Application Number
151215
Product/Active constituent Name
Application Product Name
MOXISOLV POUR-ON FOR CATTLE AND RED DEER
Application Date
Application Number
151215
Application Product Name
MOXISOLV POUR-ON FOR CATTLE AND RED DEER
Application details
Product name:
MOXISOLV POUR-ON FOR CATTLE AND RED DEER
Product number:
96906
Applicant Name:
BIMEDA (AUSTRALIA) PTY. LIMITED
Application purpose and description of use:
Registration of a 5 g/L moxidectin pour-on product for the treatment and control of moxidectin-sensitive internal and external parasites of cattle and for the treatment and control of lungworm and gastrointestinal roundworms of red deer.
Reference details:
45970 - CYDECTIN POUR-ON FOR CATTLE AND RED DEER
Active constituents:
Active constituent name
95270 - Moxidectin
Description of data provided:
Data no
304786
Title
Report
Study date
2026
Auth party contact address
Level 31, Suite 31.01 International Towers 264 George Street SYDNEY Australia
Data no
304789
Title
Justification
Study date
2026
Auth party contact address
Level 31, Suite 31.01 International Towers 264 George Street SYDNEY Australia
Data no
296300
Title
Product specifications
Study date
2025
Auth party contact address
Level 31, Suite 31.01 International Towers 264 George Street SYDNEY Australia
Data no
304784
Title
Explanation
Study date
2026
Auth party contact address
Level 31, Suite 31.01 International Towers 264 George Street SYDNEY Australia
Data no
304787
Title
Report
Study date
2026
Auth party contact address
Level 31, Suite 31.01 International Towers 264 George Street SYDNEY Australia
Data no
304788
Title
Product specifications
Study date
2026
Auth party contact address
Level 31, Suite 31.01 International Towers 264 George Street SYDNEY Australia
Data no
304785
Title
Monograph
Study date
2026
Auth party contact address
-
Date
Application Date
Application No
Application Number
151251
Product/Active constituent Name
Application Product Name
RICHGRO ANT KILLA
Application Date
Application Number
151251
Application Product Name
RICHGRO ANT KILLA
Application details
Product name:
RICHGRO ANT KILLA
Product number:
59354
Applicant Name:
A. RICHARDS PTY LTD
Application purpose and description of use:
Variation of label approval to add fire ants to the statement of claim and directions for use.
Active constituents:
Active constituent name
44362 - BIFENTHRIN
Active constituent name
55353 - BIFENTHRIN
Description of data provided:
Data no
299746
Title
59354 AA letter
Study date
3 December 2025
Auth party contact address
203 ACOURT RD JANDAKOT Australia
Data no
299747
Title
A field efficacy evaluation of Richgro Ant Killa Granular Insecticide for the control of populations of the red imported fire ant (Solenopsis invicta)
Study date
April 2025
Auth party contact address
203 ACOURT RD JANDAKOT Australia
Date
Application Date
Application No
Application Number
151320
Product/Active constituent Name
Application Product Name
IMTRADE TUTOR 900 WG FUNGICIDE
Application Date
Application Number
151320
Application Product Name
IMTRADE TUTOR 900 WG FUNGICIDE
Application details
Product name:
IMTRADE TUTOR 900 WG FUNGICIDE
Product number:
92182
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to add uses for control of Ring Spot on Brassica Vegetables, Powdery Mildew in various crops, Pineapple disease in Sugarcane and Myrtle Rust in various situations as specified in the Directions for Use Table. Update of Nominated Manufacturing Sites.
Reference details:
48957 - RICHGRO MANCOZEB PLUS SULPHUR FUNGICIDE
84304 - Surefire Triadimenol 250 EC Fungicide
84304 - Surefire Trident 250 EC Fungicide
Active constituents:
Active constituent name
53391 - TRIADIMENOL
Description of data provided:
Data no
299605
Title
Investigation into the Bio-equivalency of IMTRADE TUTOR?? 900 WG FUNGICIDE to that of SUREFIRE TRIADIMENOL 250 EC FUNGICIDE for the control of Ring Spot in Broccoli cv. Legacy. ??? One Trial, Peak Crossing, Queensland.
Study date
21/08/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299611
Title
Commentary to Support Efficacy and Host Crop Safety submitted
Study date
08/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299608
Title
Investigation into the Equivalence of IMTRADE TUTOR?? 900 WG FUNGICIDE to SUREFIRE TRIADIMENOL 250 EC FUNGICIDE for the control of Powdery Mildew in Zucchini cv. Enzo. ??? One Trial, Bundaberg, Queensland.
Study date
14/11/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299609
Title
Investigation into the Equivalence of IMTRADE TUTOR?? 900 WG FUNGICIDE to SUREFIRE TRIADIMENOL 250 EC FUNGICIDE for the control of Powdery Mildew in Tomato cv. Rifle. ??? One Trial, Bundaberg, Queensland.
Study date
20/11/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299606
Title
Investigation into the Bio-equivalency of IMTRADE TUTOR?? 900 WG FUNGICIDE to that of SUREFIRE TRIADIMENOL 250 EC FUNGICIDE for the control of Ring Spot in Cabbage cv. Estrema. ??? One Trial, Peak Crossing, Queensland.
Study date
26/08/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299612
Title
Imt TUTOR?? 900 WG Fungicide - RLP_V1 pending 101225 - MARKED COPY
Study date
10/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299607
Title
Investigation into the Equivalence of IMTRADE TUTOR?? 900 WG FUNGICIDE to SUREFIRE TRIADIMENOL 250 EC FUNGICIDE for the control of Powdery Mildew in Pumpkin cv. Jarrahdale. ??? One Trial, Forest Hill, Queensland.
Study date
09/09/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299604
Title
Investigation into the Host Crop Safety of IMTRADE TUTOR?? 900 WG FUNGICIDE to that of BAYFIDAN 250 EC FUNGICIDE for the control of Powdery Mildew in Grapevines cv. Chardonnay - One Trial, Renmark, South Australia.
Study date
25/05/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299610
Title
Investigation into the Equivalence of IMTRADE TUTOR?? 900 WG FUNGICIDE to SUREFIRE TRIADIMENOL 250 EC FUNGICIDE for the control of Powdery Mildew in Capsicum cv. Verde. ??? One Trial, Bundaberg, Queensland.
Study date
28/11/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date
Application Date
Application No
Application Number
151321
Product/Active constituent Name
Application Product Name
EMAMECTIN BENZOATE
Application Date
Application Number
151321
Application Product Name
EMAMECTIN BENZOATE
Application details
Product name:
EMAMECTIN BENZOATE
Active name:
EMAMECTIN BENZOATE
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of Emamectin Benzoate for use in agricultural chemical products.
Description of data provided:
Data no
299556
Title
Certificate of Analysis (CoA) - Emamectin Benzoate Tech Commercial Batches
Study date
11/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299559
Title
Letter of Declaration - Company Address
Study date
19/12/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299553
Title
Analysis Method - Emamectin Benzoate Technical
Study date
22/09/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299551
Title
PART 1 - EXECUTIVE SUMMARY; PART 2 - CHEMISTRY & MANUFACTURE SUMMARY
Study date
11/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299554
Title
Declaration of Composition (DoC) - Emamectin Benzoate
Study date
10/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299557
Title
MSDS for Emamectin Benzoate TC
Study date
26/06/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299552
Title
Method of Manufacture - Emamectin Benzoate Tech
Study date
10/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299558
Title
Letter of Support / Authorisation from Source - Emamectin Benzoate
Study date
08/09/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299555
Title
Five Batch Analysis of Emamectin Benzoate Technical - Study No. 0335
Study date
09/11/2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date
Application Date
Application No
Application Number
151329
Product/Active constituent Name
Application Product Name
Titan Flumioxazin 500 WG Herbicide
Application Date
Application Number
151329
Application Product Name
Titan Flumioxazin 500 WG Herbicide
Application details
Product name:
Titan Flumioxazin 500 WG Herbicide
Product number:
87182
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Variation of label approval to add a new use for suppression of a range of broadleaf weeds when applied pre-emergent incorporated by sowing (IBS) in wheat, and for suppression or control when tank mixed with Titan Trifluralin 480 Selective Herbicide plus Titan Triallate 500 EC Herbicide pre-emergent incorporated by sowing (IBS) in wheat. The new use is the same as currently registered for the reference product Valor 500 WG.
Reference details:
61622 - VALOR 500 WG HERBICIDE
Active constituents:
Active constituent name
80466 - flumioxazin
Description of data provided:
Data no
299656
Title
Titan Flumioxazin 500 WG Efficacy and Crop Safety Module 8.3
Study date
12 December 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
299654
Title
Bioequivalence of Titan Flumioxazin 500 to Valor for control of annual ryegrass and volunteer canola in Wheat
Study date
14.11.2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
299655
Title
Titan Flumioxazin 500 WG Herbicide draft label
Study date
11.12.2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
151331
Product/Active constituent Name
Application Product Name
PIPERONYL BUTOXIDE
Application Date
Application Number
151331
Application Product Name
PIPERONYL BUTOXIDE
Application details
Product name:
PIPERONYL BUTOXIDE
Active name:
PIPERONYL BUTOXIDE
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of PIPERONYL BUTOXIDE for use in agricultural chemical products.
Description of data provided:
Data no
299539
Title
Five Batch Analysis Report - Piperonyl Butoxide Technical - Study No. NC-202-073 (293 pages in total comprising 6 parts)
Study date
09/10/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299542
Title
Letter of Support / Authorisation from Source - Piperonyl Butoxide Technical
Study date
15/10/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299536
Title
Method of Manufacture - Piperonyl Butoxide Technical
Study date
12/05/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299537
Title
Analysis Method - Piperonyl Butoxide
Study date
12/05/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299543
Title
Statement regarding Addresses
Study date
25/11/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299540
Title
Certificate of Analysis (CoA) - Piperonyl Butoxide Tech Commercial Batches
Study date
Apr 2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
311279
Title
Methof of Manufacture
Study date
28/08/2026
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299541
Title
SDS for Piperonyl Butoxide
Study date
30/05/2019
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299535
Title
PART 1 - EXECUTIVE SUMMARY; PART 2 - CHEMISTRY & MANUFACTURE SUMMARY
Study date
09/12/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
311280
Title
Enforcement Analytical Methods of Active Ingredient and Dihydrosafrole in Piperonyl Butoxide.
Study date
31/08/2026
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
299538
Title
Declaration of Composition (DoC) - Piperonyl Butoxide
Study date
12/05/2025
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date
Application Date
Application No
Application Number
151303
Product/Active constituent Name
Application Product Name
Submarino Paraquat 360 SL Herbicide
Application Date
Application Number
151303
Application Product Name
Submarino Paraquat 360 SL Herbicide
Application details
Product name:
Submarino Paraquat 360 SL Herbicide
Applicant Name:
SUBMARINO PTY LTD
Application purpose and description of use:
Registration of a 360 g/L paraquat, present as paraquat dichloride, soluble concentrate formulation
for the control of a wide range of grasses and broadleaf weeds
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.
Date
Application Date
Application No
Application Number
151249
Product/Active constituent Name
Application Product Name
Credelio Plus Chewable Tablets for Large Dogs
Application Date
Application Number
151249
Application Product Name
Credelio Plus Chewable Tablets for Large Dogs
Application details
Product name:
Credelio Plus Chewable Tablets for Large Dogs
Product number:
89318
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.
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.
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.
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.
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
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
309789
Title
03Aug2026_DP stability data 18CQ123
Study date
30 Sep 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
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
309790
Title
Stability Development Report SDR209.01
Study date
11 Oct 2016
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
Data no
309788
Title
27Jul2026_Surolan_HA RTQ_AU (response to questions)
Study date
Aug 2026
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
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
309440
Title
Elemental Impurities Assessment Report EI-R-1074-02
Study date
Oct 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
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
309441
Title
20260729 response doc
Study date
29 JUL 2026
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
309439
Title
Certificates of Analysis
Study date
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
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
Active constituent name
92406 - Brodifacoum Manufacturing Concentrate
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
151109
Product/Active constituent Name
Application Product Name
VAXSAFE IB VACCINE (LIVING)
Application Date
Application Number
151109
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
Active constituent name
98132 - Vaxsafe IB
Description of data provided:
Data no
309649
Title
Attachment 1 potency_appearance results
Study date
July 2026
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
295847
Title
Executive Summary
Study date
November 2025
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
309650
Title
Attachment 2 Vacuum & moisture data
Study date
July 2026
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
295848
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
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
309651
Title
Attachment 3 Sterility data
Study date
July 2026
Auth party contact address
36 CHARTER ST RINGWOOD Australia
Data no
309648
Title
S159app151109
Study date
July 2026
Auth party contact address
36 CHARTER ST RINGWOOD Australia