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
149176
Product/Active constituent Name
Application Product Name
Cefeject + KP Injection for Cattle
Application Date
Application Number
149176
Application Product Name
Cefeject + KP Injection for Cattle
Application details
Product name:
Cefeject + KP Injection for Cattle
Product number:
96396
Applicant Name:
ABBEY LABORATORIES PTY LTD
Application purpose and description of use:
Registration of Cefeject + KP Injection for Cattle containing Ceftiofur (as hydrochloride) 50 mg/mL and Ketoprofen 150 mg/mL for the treatment of respiratory infections in cattle associated with signs of inflammation or pyrexia.
For the treatment of bovine respiratory disease (BRD) caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni susceptible to ceftiofur and the reduction of associated clinical signs of inflammation or pyrexia.
Reference details:
83071 - CURACEF DUO Suspension for Injection for Cattle
Active constituents:
Active constituent name
84288 - CEFTIOFUR HYDROCHLORIDE
Active constituent name
55648 - KETOPROFEN
Active constituent name
94214 - Ketoprofen
Description of data provided:
Data no
289182
Title
Cefeject + KP Injection for Cattle
Study date
Jul 25
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Date
Application Date
Application No
Application Number
149280
Product/Active constituent Name
Application Product Name
EPRINOMECTIN
Application Date
Application Number
149280
Application Product Name
EPRINOMECTIN
Application details
Product name:
EPRINOMECTIN
Active name:
EPRINOMECTIN
Applicant Name:
BIMEDA (AUSTRALIA) PTY. LIMITED
Application purpose and description of use:
Approval of eprinomectin for use in veterinary chemical products.
Description of data provided:
Data no
289448
Title
Certificates of analysis
Study date
2024
Auth party contact address
C/- KPMG, LEVEL 38,Tower Three International Towers 300 Barangaroo Avenue SYDNEY Australia
Date
Application Date
Application No
Application Number
149040
Product/Active constituent Name
Application Product Name
GENFARM CLOPYRALID 300 SL HERBICIDE
Application Date
Application Number
149040
Application Product Name
GENFARM CLOPYRALID 300 SL HERBICIDE
Application details
Product name:
GENFARM CLOPYRALID 300 SL HERBICIDE
Product number:
90600
Applicant Name:
NUTRIEN AG SOLUTIONS LIMITED
Application purpose and description of use:
Variation of 300 g/L soluble concentrate clopyralid registration to add an alternative formulation.
Reference details:
94997 - Avilive Clopyralid 300SL Herbicide
Active constituents:
Active constituent name
53536 - CLOPYRALID
Description of data provided:
Data no
292118
Title
Supporting documentation for DC12-52562582 Genfarm Clopyralid 300 SL Herbicide
Study date
July 2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
149150
Product/Active constituent Name
Application Product Name
INDEPENDENTS OWN TRIPLETEC 3-WAY COMBINATION DRENCH FOR SHEEP
Application Date
Application Number
149150
Application Product Name
INDEPENDENTS OWN TRIPLETEC 3-WAY COMBINATION DRENCH FOR SHEEP
Application details
Product name:
INDEPENDENTS OWN TRIPLETEC 3-WAY COMBINATION DRENCH FOR SHEEP
Applicant Name:
THE HUNTER RIVER COMPANY PTY LIMITED
Application purpose and description of use:
Registration of a 25.5 g/L levamisole (as levamisole hydrochloride), 20 g/L albendazole, 1.76 g/L cobalt (as cobalt EDTA), 0.8 g/L abamectin and 0.4 g/L selenium (as sodium selenate) drench for the control of gastrointestinal parasites, lungworm, itchmite and nasal bot in sheep.
Date
Application Date
Application No
Application Number
149014
Product/Active constituent Name
Application Product Name
Indoxacarb
Application Date
Application Number
149014
Application Product Name
Indoxacarb
Application details
Product name:
Indoxacarb
Active name:
Indoxacarb
Applicant Name:
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
Application purpose and description of use:
Approval of Indoxacarb for use in veterinary chemical products.
Description of data provided:
Data no
289454
Title
Certificates of analysis
Study date
04/2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
289452
Title
Process Validation
Study date
06/2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
289453
Title
DMF
Study date
06/2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Date
Application Date
Application No
Application Number
148807
Product/Active constituent Name
Application Product Name
GORNA Fungicide
Application Date
Application Number
148807
Application Product Name
GORNA Fungicide
Application details
Product name:
GORNA Fungicide
Product number:
96287
Applicant Name:
Shandong Rainbow International Co Ltd
Application purpose and description of use:
Registration of a 500g/L Fluopyram suspension concentrate formulation (SC) product , GORNA FUNGICIDE for control of various pest species in Banana as described in the Directions for use section of the label.
Active constituents:
Active constituent name
93993 - Fluopyram
Description of data provided:
Data no
288741
Title
Specifications of Fluopyram 500g/L SC Product
Study date
10 May 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288740
Title
Declaration of composition of Fluopyram technical
Study date
10 May 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288754
Title
Certificate of analysis - Fluopyram reference std
Study date
15 Oct 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288755
Title
Certificate of Analysis Fluopyram technical
Study date
22 Jul 2023
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288747
Title
Method Validation - Fluopyram 500g/L SC product
Study date
15 Oct 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288749
Title
Analysis of Method validation part 2- Fluopyram 500g/L SC product
Study date
15 Oct 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288750
Title
Chromatogram Linearity- Fluopyram 500 g/L SC product
Study date
15 Oct 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288751
Title
Chromatogram Accuracy- Fluopyram 500 g/L SC product
Study date
15 Oct 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288752
Title
Chromatogram Solvent- Fluopyram 500 g/L SC product
Study date
15 Oct 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288753
Title
Chromatogram Stadard Solution- Fluopyram 500 g/L SC product
Study date
15 Oct 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288748
Title
Packaging Specifications
Study date
10 May 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288742
Title
Manufacturing process of Fluopyram 500g/L SC product
Study date
10 May 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288743
Title
Certificate of Analysis - Fluopyram 500g/L SC product
Study date
11 Feb 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288744
Title
GORNA FUNGICIDE - Manufacturing process
Study date
27 May 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288739
Title
Part 2 - Chemistry and Manufacture - GORNA Fungicide
Study date
11 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288757
Title
SDS combined- Fluopyram 500SC and other ingredients
Study date
6 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288745
Title
Accelerated storage stability study on Fluopyram 500 g/L SC
Study date
24 Mar 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288746
Title
Low Temperature storage stability - Fluopyram 500g/L SC
Study date
10 May 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288763
Title
Part 8 - Crop Efficacy and Safety
Study date
11 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288764
Title
Field trial report in Banana crop - Qld 2024
Study date
23 May 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288765
Title
Draft Proposed GORNA Fungicide label
Study date
11 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288766
Title
Ref Market standard label
Study date
10 June 2025
Auth party contact address
-
Data no
288756
Title
Authorised agent letter
Study date
26 May 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288762
Title
Supporting information- Public release summary- Reference market product
Study date
Apr 2015
Auth party contact address
102 Taylor Street, Armidale, NSW, 2350, Australia
Data no
288758
Title
Part 3- Toxicity dossier
Study date
10 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288759
Title
Toxicological end points - Fluopyram technical
Study date
21 May 2019
Auth party contact address
-
Data no
288760
Title
Six pack Toxicity - combined report
Study date
24 Oct 2019
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288761
Title
Combined SDS- Product and ingredients
Study date
6 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Date
Application Date
Application No
Application Number
148875
Product/Active constituent Name
Application Product Name
Halosulfuron Methyl
Application Date
Application Number
148875
Application Product Name
Halosulfuron Methyl
Application details
Product name:
Halosulfuron Methyl
Active name:
Halosulfuron Methyl
Applicant Name:
Shandong Rainbow International Co Ltd
Application purpose and description of use:
Approval of halosulfuron methyl for use in agricultural chemical products.
Description of data provided:
Data no
288078
Title
Deterrmination of Active Content and Impurity Technical Profile of Halosulfuron-methyl
Study date
August, 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288077
Title
Part 2 - Volume 1
Study date
June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288076
Title
Covering Letter/Executive Summary
Study date
June, 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288079
Title
Letter of Authorisation
Study date
May, 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Date
Application Date
Application No
Application Number
148804
Product/Active constituent Name
Application Product Name
INEGO XTRA HERBICIDE
Application Date
Application Number
148804
Application Product Name
INEGO XTRA HERBICIDE
Application details
Product name:
INEGO XTRA HERBICIDE
Applicant Name:
ADAMA AUSTRALIA PTY LIMITED
Application purpose and description of use:
Registration of Pinoxaden 50 g/L + Cloquintocet-Mexyl EC for uses as proposed on the submitted label.
Date
Application Date
Application No
Application Number
148314
Product/Active constituent Name
Application Product Name
ECOVACPLE - E.COLI / PARVOVIRUS / ERYSIPELAS / LEPTOSPIROSIS VACCINE FOR PIGS
Application Date
Application Number
148314
Application Product Name
ECOVACPLE - E.COLI / PARVOVIRUS / ERYSIPELAS / LEPTOSPIROSIS VACCINE FOR PIGS
Application details
Product name:
ECOVACPLE - E.COLI / PARVOVIRUS / ERYSIPELAS / LEPTOSPIROSIS VACCINE FOR PIGS
Product number:
46163
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product registration to add manufacturing sites.
Active constituents:
Active constituent name
85949 - Whole cell E. coli including fimbrial antigens K88, K99 and 987P
Active constituent name
85954 - Leptospira interrogans serovar pomona
Description of data provided:
Data no
285634
Title
Evidence of GMP 1
Study date
Feb 2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285635
Title
Evidence of GMP 2
Study date
Mar 2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
148315
Product/Active constituent Name
Application Product Name
ECOVACLE-E.COLI/ERYSIPELAS/LEPTOSPIROSIS VACCINE FOR PIGS
Application Date
Application Number
148315
Application Product Name
ECOVACLE-E.COLI/ERYSIPELAS/LEPTOSPIROSIS VACCINE FOR PIGS
Application details
Product name:
ECOVACLE-E.COLI/ERYSIPELAS/LEPTOSPIROSIS VACCINE FOR PIGS
Product number:
46409
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product registration to add manufacturing sites.
Active constituents:
Active constituent name
85949 - Whole cell E. coli including fimbrial antigens K88, K99 and 987P
Active constituent name
85954 - Leptospira interrogans serovar pomona
Description of data provided:
Data no
285636
Title
Evidence of GMP 1
Study date
Feb 2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285637
Title
Evidence of GMP 2
Study date
Mar 2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
149186
Product/Active constituent Name
Application Product Name
Enduramec Horse Paste
Application Date
Application Number
149186
Application Product Name
Enduramec Horse Paste
Application details
Product name:
Enduramec Horse Paste
Product number:
85529
Applicant Name:
THE HUNTER RIVER COMPANY PTY LIMITED
Application purpose and description of use:
Variation of product registration and label approval to vary relevant particulars.
Active constituents:
Active constituent name
82676 - Ivermectin
Description of data provided:
Data no
289207
Title
Certificate
Study date
2025
Auth party contact address
74-76 Drummond Road SHEPPARTON Australia
Date
Application Date
Application No
Application Number
149234
Product/Active constituent Name
Application Product Name
Coopers Revalor XR Growth Promotant and Finishing Implants
Application Date
Application Number
149234
Application Product Name
Coopers Revalor XR Growth Promotant and Finishing Implants
Application details
Product name:
Coopers Revalor XR Growth Promotant and Finishing Implants
Product number:
90903
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of label approval to update a restraint statement.
Active constituents:
Active constituent name
56436 - TRENBOLONE ACETATE
Active constituent name
89740 - TRENBOLONE ACETATE
Active constituent name
85769 - ESTRADIOL
Description of data provided:
Data no
289383
Title
Response to residues and trade evaluation
Study date
Nov 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
289381
Title
Application overview
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
289384
Title
Response to s159 notice
Study date
Feb 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
289385
Title
Section 159 notice
Study date
Jan 2022
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
289382
Title
Residues and Trade Evaluation Report
Study date
Oct 2021
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
148317
Product/Active constituent Name
Application Product Name
ECOVAC E COLI VACCINE FOR PIGS
Application Date
Application Number
148317
Application Product Name
ECOVAC E COLI VACCINE FOR PIGS
Application details
Product name:
ECOVAC E COLI VACCINE FOR PIGS
Product number:
35779
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product registration to add manufacturing sites.
Active constituents:
Active constituent name
85949 - Whole cell E. coli including fimbrial antigens K88, K99 and 987P
Description of data provided:
Data no
285638
Title
Evidence of GMP 1
Study date
Feb 2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
285639
Title
Evidence of GMP 2
Study date
Mar 2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
148930
Product/Active constituent Name
Application Product Name
Robenacoxib
Application Date
Application Number
148930
Application Product Name
Robenacoxib
Application details
Product name:
Robenacoxib
Active name:
Robenacoxib
Applicant Name:
INTAS PHARMACEUTICALS LIMITED
Description of data provided:
Data no
287761
Title
DMF-32s42
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287762
Title
DMF-32s43
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287763
Title
DMF-32s44
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287764
Title
DMF-32s45
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287752
Title
DMF-32s21
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287753
Title
DMF-32s22
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287754
Title
DMF-32s23
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287755
Title
DMF-32s24
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287756
Title
DMF-32s25
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287757
Title
DMF-32s26
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287758
Title
DMF-32s31
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287759
Title
DMF-32s32
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287760
Title
DMF-32s41
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287765
Title
DMF-32s5
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287766
Title
DMF-32s6
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287749
Title
DMF-32s13
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287750
Title
DMF-32s12
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287751
Title
DMF-32s11
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287767
Title
DMF-32s71
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287768
Title
DMF-32s72
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287769
Title
DMF-32s73
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
288056
Title
Certificates of analysis
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Date
Application Date
Application No
Application Number
148989
Product/Active constituent Name
Application Product Name
Fresnil Herbicide
Application Date
Application Number
148989
Application Product Name
Fresnil Herbicide
Application details
Product name:
Fresnil Herbicide
Product number:
96336
Applicant Name:
Shandong Rainbow International Co Ltd
Application purpose and description of use:
Registration of a new Fresnil Herbicide 400g/L bromoxynil (present as bromoxynil octanoate) product label for the control of certain broadleaf weeds in cereals, linseed, clover, lucerne, turf, fallow and non-crop situations as specified in the Directions for use table.
Reference details:
80801 - BRONCO 400 HERBICIDE
Active constituents:
Active constituent name
94182 - Bromoxynil Octanoate
Description of data provided:
Data no
289355
Title
Specifications of Bromoxynil as the Octanoate 400 EC
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289360
Title
Declaration of Composition of Bromoxynil Octanoate Technical
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289363
Title
CoA of Bromoxynil Octanoate Std.
Study date
18 Dec 2023
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289365
Title
CoA of Bromoxynil Octanoate technical
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289368
Title
Analysis method of Bromoxynil as the Octanoate 400EC
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289369
Title
Chromatograms of Accuracy and Precision
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289356
Title
Manufacturing Process of Bromoxynil 400EC
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289357
Title
Recipe information of Bromoxynil present as Octanoate 400EC
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289358
Title
Method Validation for Bromoxynil present as Octanoate 400 EC
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289359
Title
Storage Stability Study of Bromoxynil As the Octanoate) 400 EC
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289361
Title
COA of Bromoxynil As the Octanoate 400 EC
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289362
Title
SDS - Combined Product and other ingredients
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289370
Title
Chromatogram of Bromoxynil content
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289371
Title
Chromatogram of Linearity
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289372
Title
Chromatogram of Solvet blank
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289366
Title
Packagaing specification of Bromoxynil as the Octanoate 400EC
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289367
Title
Nominated agent letter
Study date
26 May 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289354
Title
Part 2- Chemistry and Manufacture
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289364
Title
Low Temperature Stability Report of Bromoxynil(As the Octanoate) 400 EC
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289373
Title
Part 8 - Crop efficacy and safety
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289376
Title
Bromoxynil 400 - BLW control in oats undersown to lucerne (SA)
Study date
28-04-2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289377
Title
Bromoxynil 400 wheat trial Victoria.
Study date
20-10-2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289378
Title
Bromoxynil 400 WHT Trial - Replicated Katanning
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289380
Title
Reference Market standard label
Study date
30 June 2025
Auth party contact address
-
Data no
289374
Title
Fresnil Herbicide proposed draft label
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289375
Title
SDSs_Combined product and other ingredients
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289391
Title
Letter Justification
Study date
2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289379
Title
Market standard reference label
Study date
29 June 2025
Auth party contact address
-
Date
Application Date
Application No
Application Number
148929
Product/Active constituent Name
Application Product Name
ROBENACOXIB 20 MG/ML SOLUTION FOR INJECTION
Application Date
Application Number
148929
Application Product Name
ROBENACOXIB 20 MG/ML SOLUTION FOR INJECTION
Application details
Product name:
ROBENACOXIB 20 MG/ML SOLUTION FOR INJECTION
Product number:
96322
Applicant Name:
INTAS PHARMACEUTICALS LIMITED
Application purpose and description of use:
Registration of a 20 mg/mL robenacoxib injectable product for the treatment of pain and inflammation associated with orthopaedic or soft tissue surgery in dogs and cats.
Reference details:
63112 - ONSIOR INJECTION FOR CATS AND DOGS
Description of data provided:
Data no
287744
Title
Product specifications
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287745
Title
Certificate
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Date
Application Date
Application No
Application Number
148961
Product/Active constituent Name
Application Product Name
DAVID GRAYS FIPRONIL 100SC TERMITICIDE AND INSECTICIDE
Application Date
Application Number
148961
Application Product Name
DAVID GRAYS FIPRONIL 100SC TERMITICIDE AND INSECTICIDE
Application details
Product name:
DAVID GRAYS FIPRONIL 100SC TERMITICIDE AND INSECTICIDE
Product number:
90608
Applicant Name:
DAVID GRAY & CO. PTY LIMITED
Application purpose and description of use:
Variation of product label only:
Variation to ''General Instructions'' Section ONLY.
Inserting ''sands'' Under Soil Type. Hole Spacing - 300mm.
Inserting ''Sands'' Under Concrete Rodding - Hole Spacing - 300mm.
No other changes performed within the label, pack size, formulation, or site of manufacture.
Efficacy report completed for our current registered formulation as per AS3660.2-2014.
Active constituents:
Active constituent name
58418 - FIPRONIL
Description of data provided:
Data no
289296
Title
Efficacy of David Grays Fipronil 100SC Termiticide and Insecticide
Study date
14/03/2025
Auth party contact address
2 RAWLINSON ST O'CONNOR Australia
Date
Application Date
Application No
Application Number
149119
Product/Active constituent Name
Application Product Name
VETORYL 30 MG CAPSULES
Application Date
Application Number
149119
Application Product Name
VETORYL 30 MG CAPSULES
Application details
Product name:
VETORYL 30 MG CAPSULES
Product number:
60620
Applicant Name:
DECHRA LTD
Application purpose and description of use:
Variation of label approval to copy uses from a closely similar reference product and to update the label in accordance with the Labelling Code.
Active constituents:
Active constituent name
86002 - TRILOSTANE
Date
Application Date
Application No
Application Number
149120
Product/Active constituent Name
Application Product Name
VETORYL 60 MG CAPSULES
Application Date
Application Number
149120
Application Product Name
VETORYL 60 MG CAPSULES
Application details
Product name:
VETORYL 60 MG CAPSULES
Product number:
60619
Applicant Name:
DECHRA LTD
Application purpose and description of use:
Variation of label approval to copy uses from a closely similar reference product and to update the label in accordance with the Labelling Code.
Active constituents:
Active constituent name
86002 - TRILOSTANE
Date
Application Date
Application No
Application Number
149121
Product/Active constituent Name
Application Product Name
VETORYL 120 MG CAPSULES
Application Date
Application Number
149121
Application Product Name
VETORYL 120 MG CAPSULES
Application details
Product name:
VETORYL 120 MG CAPSULES
Product number:
60618
Applicant Name:
DECHRA LTD
Application purpose and description of use:
Variation of label approval to copy uses from a closely similar reference product and to update the label in accordance with the Labelling Code.
Active constituents:
Active constituent name
86002 - TRILOSTANE