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
148055
Product/Active constituent Name
Application Product Name
Dechra Firocoxib 227mg Tablets
Application Date
Application Number
148055
Application Product Name
Dechra Firocoxib 227mg Tablets
Application details
Product name:
Dechra Firocoxib 227mg Tablets
Product number:
96065
Applicant Name:
DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.
Application purpose and description of use:
Registration of a 227mg/tablet firocoxib tablet product for relief of pain and control of inflammation associated with osteoarthritis and other musculo-skeletal disorders. Also indicated for the control of post-operative pain associated with surgery; including soft tissue, orthopaedic and dental procedures.
Reference details:
58093 - PREVICOX 57MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN & INFLAMMATION CONTROL
57941 - PREVICOX 227MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN & INFLAMMATION CONTROL FOR DOGS
Active constituents:
Active constituent name
96068 - Firocoxib
Active constituent name
96064 - Firocoxib
Description of data provided:
Data no
285013
Title
Firocoxib Certificates of Analysis
Study date
2023
Auth party contact address
2 Cal Close Somersby Australia
Data no
285011
Title
Active Substance Master File - part 1
Study date
May 2021
Auth party contact address
2 Cal Close Somersby Australia
Data no
285012
Title
Active Substance Master File - part 2
Study date
May 2021
Auth party contact address
2 Cal Close Somersby Australia
Data no
285015
Title
ASTM001
Study date
19 May 2021
Auth party contact address
2 Cal Close Somersby Australia
Data no
285016
Title
ASTM002
Study date
4 August 2021
Auth party contact address
2 Cal Close Somersby Australia
Data no
285017
Title
ASTM003
Study date
4 August 2021
Auth party contact address
2 Cal Close Somersby Australia
Data no
285018
Title
ASTM009
Study date
20 October 2020
Auth party contact address
2 Cal Close Somersby Australia
Data no
285019
Title
ASTM010
Study date
4 August 2021
Auth party contact address
2 Cal Close Somersby Australia
Data no
285020
Title
Appendix XVI B. Microbiological Examination of Non-sterile Products
Study date
1 January 2025
Auth party contact address
2 Cal Close Somersby Australia
Data no
285021
Title
ASTM211
Study date
5 September 2023
Auth party contact address
2 Cal Close Somersby Australia
Data no
285022
Title
AMVP23_01
Study date
4 September 2023
Auth party contact address
2 Cal Close Somersby Australia
Data no
285023
Title
Foil Specification
Study date
27 February 2023
Auth party contact address
2 Cal Close Somersby Australia
Data no
285014
Title
Excipient monographs and certificates of analysis
Study date
December 2024
Auth party contact address
2 Cal Close Somersby Australia
Data no
285010
Title
Module 2.3 - Chemistry and Manufacture
Study date
March 2025
Auth party contact address
2 Cal Close Somersby Australia
Data no
285025
Title
Analgesic efficacy of oral firocoxib in ovariohysterectomized cats
Study date
2017
Auth party contact address
-
Data no
285026
Title
KFl-056-KC-3316
Study date
8 June 2017
Auth party contact address
2 Cal Close Somersby Australia
Data no
285027
Title
KFl-056-BC-4118
Study date
5 March 2019
Auth party contact address
2 Cal Close Somersby Australia
Data no
285028
Title
Pre-application assistance (PAA) - meeting record and advice
Study date
21 February 2024
Auth party contact address
2 Cal Close Somersby Australia
Data no
285029
Title
DEC C 24035 W
Study date
31 January 2025
Auth party contact address
2 Cal Close Somersby Australia
Data no
285030
Title
Comparative dissolution study protocol
Study date
30 January 2025
Auth party contact address
2 Cal Close Somersby Australia
Data no
285031
Title
Comparative dissolution study report
Study date
2 April 2025
Auth party contact address
2 Cal Close Somersby Australia
Data no
285024
Title
Module 8.3 - Efficacy and Safety
Study date
March 2025
Auth party contact address
2 Cal Close Somersby Australia
Date
Application Date
Application No
Application Number
148211
Product/Active constituent Name
Application Product Name
Alion 500 SC Herbicide
Application Date
Application Number
148211
Application Product Name
Alion 500 SC Herbicide
Application details
Product name:
Alion 500 SC Herbicide
Product number:
92296
Applicant Name:
BAYER CROPSCIENCE PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to add crop groups to the situations of use.
Active constituents:
Active constituent name
65379 - INDAZIFLAM
Description of data provided:
Data no
286100
Title
Module 8
Study date
2025-04-15
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286101
Title
Efficacy of Alion 500 SC, applied for pre-emergent weed control in stone fruit. Amendment to final report. M-825136-02-1
Study date
2025-04-15
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286102
Title
Indaziflam for long term weed control in orchards. M-825167-01-1
Study date
2022-10-12
Data no
286103
Title
Indaziflam for long term weed control in orchards. M-825188-01-1
Study date
2022-10-12
Data no
286104
Title
Efficacy of BCS-AA10717 (AE1170437) applied pre-emergence as a non-selective herbicide in peaches. Amendment to final report. M-826270-02-1
Study date
2025-04-04
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286105
Title
Efficacy of BCS-AA10717 (AE1170437) applied post-emergence in combination with knockdowns as a non-selective herbicide in peaches. M-826398-02-1
Study date
2025-04-04
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286106
Title
Efficacy of BCS-AA10717 (AE1170437) applied post-emergence as a non-selective herbicide in peaches. M-876054-01-1
Study date
2009-08-06
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286107
Title
Evaluation of BCS-AA10717 500 SC and AE 1801486 50 WG alone and in mixtures with Roundup Power Max 540 SL and Hasten 704 SL adjuvant for knockdown and residual weed control in stone fruit. M-876347-01-1
Study date
2009-10-20
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286108
Title
Evaluation of BCS-AA10717 500 SC and AE 1801486 alone and in mixtures with glyphosate 540 g/L for weed control in stone fruit. M-876348-01-1
Study date
2009-10-20
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286109
Title
Evaluation of BCS-AA10717 500 SC and AE 1801486 alone and in mixtures with glyphosate 540 g/L for weed control in stone fruit. M-876349-01-1
Study date
2009-11-20
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286110
Title
Evaluation of herbicide grass weed control in orchards. M-876350-01-1
Study date
2024-04-17
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286111
Title
Evaluation of BCS-AA10717 500 SC and AE 1801486 50 WG alone and in mixtures with Roundup Power Max 540 SL and Hasten 704 SL adjuvant for knockdown and residual weed control in stone fruit. M-876351-01-1
Study date
2009-01-29
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286112
Title
Evaluation of BCS-AA10717 500 SC and AE 1801486 50 WG alone and in mixtures with Roundup Power Max 540 SL and Hasten 704 SL adjuvant for knockdown and residual weed control in pome fruit. M-876443-01-1
Study date
2009-01-29
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286113
Title
Evaluation of nectarine crop safety from Indaziflam 500 SC application. M-876444-01-1
Study date
2024-04-17
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286114
Title
Indaziflam plus glyphosate for control of weeds in orchards. M-876463-01-1
Study date
2024-04-17
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286090
Title
Determination of the residues of AE 1170437 in/on peach after spraying of AE 1170437 (500 SC) in the field in Germany, Spain and Italy - Amendment no. 1 to final report. M-308114-02-1
Study date
2023-03-01
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286091
Title
Determination of the residues of AE 1170437 in/on cherry after spraying of AE 1170437 (500 SC) in the field in Germany, Spain, Northern France and Italy - Amendment no. 1 to final report. M-308391-02-1
Study date
2023-03-02
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286092
Title
AE 1170437 500 SC - Magnitude of the residue in/on stone fruit (CG 12). M-347950-01-1
Study date
2009-05-20
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286093
Title
AE 1170437 500 SC - Magnitude of the residue in/on plum processed commodities. M-347951-01-1
Study date
2009-05-20
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286094
Title
AE 1170437 500 SC - Magnitude of the residue in/on pome fruit (CG 11). M-348053-01-1
Study date
2009-05-20
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286095
Title
AE 1170437 500 SC - Magnitude of the residue in/on apple processed commodities. M-348056-01-1
Study date
2009-05-20
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286096
Title
Amended study report - 485 - Determination of residues of indaziflam and its metabolite in apples and grapes. M-596268-01-1
Study date
2016-05-06
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286097
Title
Amended study report - 519 - Determination of residues of indaziflam and its metabolite in apples and grapes. M-596270-01-1
Study date
2016-05-06
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286098
Title
Determination of residues of indaziflam and its metabolite in pear and stone fruit. M-876619-01-1
Study date
2017-05-22
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286099
Title
Determination of residues of indaziflam and metabolite in stonefruit and pears. M-876620-01-1
Study date
2018-06-01
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Data no
286089
Title
Module 5 Residues
Study date
2025-04-17
Auth party contact address
Level 4, 109 Burwood Road HAWTHORN Australia
Date
Application Date
Application No
Application Number
148425
Product/Active constituent Name
Application Product Name
Triclabendazole
Application Date
Application Number
148425
Application Product Name
Triclabendazole
Application details
Product name:
Triclabendazole
Active name:
Triclabendazole
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Approval of Triclabendazole for use in veterinary chemical products.
Description of data provided:
Data no
286088
Title
CoA
Study date
2025
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Date
Application Date
Application No
Application Number
148239
Product/Active constituent Name
Application Product Name
Sabakem Glyphosate 700 SG Herbicide
Application Date
Application Number
148239
Application Product Name
Sabakem Glyphosate 700 SG Herbicide
Application details
Product name:
Sabakem Glyphosate 700 SG Herbicide
Product number:
96122
Applicant Name:
SABAKEM PTY LTD
Application purpose and description of use:
Registration of a new agricultural product containing 700 g/kg glyphosate for the control of many annual and perennial weeds.
Reference details:
66687 - AW REK HERBICIDE
Active constituents:
Active constituent name
69045 - GLYPHOSATE
Date
Application Date
Application No
Application Number
148249
Product/Active constituent Name
Application Product Name
Sabakem Fipronil 200 SC Insecticide
Application Date
Application Number
148249
Application Product Name
Sabakem Fipronil 200 SC Insecticide
Application details
Product name:
Sabakem Fipronil 200 SC Insecticide
Product number:
96123
Applicant Name:
SABAKEM PTY LTD
Application purpose and description of use:
The purpose of this application is to apply for registration of a new agricultural product containing 200g/L Fipronil Suspension concentrates (SC) formulation.
Reference details:
91862 - NAADCO Fipronil 200 SC Insecticide
Active constituents:
Active constituent name
68973 - FIPRONIL
Date
Application Date
Application No
Application Number
148339
Product/Active constituent Name
Application Product Name
Fluxapyroxad
Application Date
Application Number
148339
Application Product Name
Fluxapyroxad
Application details
Product name:
Fluxapyroxad
Active name:
Fluxapyroxad
Applicant Name:
Anhui JiuYi Agriculture Co., Ltd.
Application purpose and description of use:
Approval of Fluxapyroxad for use in agricultural chemical products.
Description of data provided:
Data no
286458
Title
Qualitative and Quantitative Profile of Fluxapyroxad Technical (Five Batch Analysis).
Study date
20 March 2024
Auth party contact address
Hefei Circulate Economy Zone Hefei City China
Data no
286456
Title
Manufacturing Process and Impurities Manufacturing Process and Impurities
Study date
15 April 2025
Auth party contact address
Hefei Circulate Economy Zone Hefei City China
Data no
286457
Title
Declaration of Composition
Study date
22 April 2025
Auth party contact address
Hefei Circulate Economy Zone Hefei City China
Data no
286459
Title
Fluxapyroxad Technical
Study date
April 2025
Auth party contact address
Hefei Circulate Economy Zone Hefei City China
Data no
286455
Title
Executive Summary
Study date
April 2025
Auth party contact address
Hefei Circulate Economy Zone Hefei City China
Date
Application Date
Application No
Application Number
148379
Product/Active constituent Name
Application Product Name
INDEPENDENTS OWN FLYK EXTRA SPRAY-ON SHEEP BLOWFLY TREATMENT
Application Date
Application Number
148379
Application Product Name
INDEPENDENTS OWN FLYK EXTRA SPRAY-ON SHEEP BLOWFLY TREATMENT
Application details
Product name:
INDEPENDENTS OWN FLYK EXTRA SPRAY-ON SHEEP BLOWFLY TREATMENT
Product number:
91207
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
64467 - DICYCLANIL
Date
Application Date
Application No
Application Number
148231
Product/Active constituent Name
Application Product Name
Hanfu MCPA 750 Herbicide
Application Date
Application Number
148231
Application Product Name
Hanfu MCPA 750 Herbicide
Application details
Product name:
Hanfu MCPA 750 Herbicide
Product number:
96118
Applicant Name:
Shanghai Hanfu Biotechnology Co., Ltd
Application purpose and description of use:
Registration of a 750 g/L MCPA soluble concentrate product for the control of broadleaf weeds in cereals, linseed, pastures, rice, sugar cane and turf as specified in the Directions for Use table.
Reference details:
87422 - F.S.A. MCPA 750 Herbicide
Active constituents:
Active constituent name
94899 - MCPA
Date
Application Date
Application No
Application Number
148232
Product/Active constituent Name
Application Product Name
Hanfu MCPA 570 Herbicide
Application Date
Application Number
148232
Application Product Name
Hanfu MCPA 570 Herbicide
Application details
Product name:
Hanfu MCPA 570 Herbicide
Product number:
96119
Applicant Name:
Shanghai Hanfu Biotechnology Co., Ltd
Application purpose and description of use:
Registration of a 570 g/L MCPA present as the 2-ethylhexyl ester emulsifiable concentrate product for Selective Control of Certain Weeds in Agricultural Crops as listed in the Directions for Use
Reference details:
87246 - F.S.A. MCPA LVE 570 Herbicide
Active constituents:
Active constituent name
90894 - MCPA-2-ethylhexyl ester
Date
Application Date
Application No
Application Number
148196
Product/Active constituent Name
Application Product Name
Gibberellin A4 with Gibberellin A7
Application Date
Application Number
148196
Application Product Name
Gibberellin A4 with Gibberellin A7
Application details
Product name:
Gibberellin A4 with Gibberellin A7
Active name:
Gibberellin A4 with Gibberellin A7
Applicant Name:
ADAMA NEW ZEALAND LTD
Application purpose and description of use:
Approval of Gibberellin A4 and Gibberellin A7 for use in agricultural chemical products.
Description of data provided:
Data no
286058
Title
Method Validation for the determination of gibberellin A4 and gibberellin A7 in a technical material (TC)
Study date
17 October 2022
Auth party contact address
Level 1, 93 Bolt Road TAHUNANANUI NELSON New Zealand
Data no
286053
Title
Impurity profile of gibberellin A4 + A7* technical material (TC) ACS-IPR-096
Study date
17 October 2022
Auth party contact address
Level 1, 93 Bolt Road TAHUNANANUI NELSON New Zealand
Data no
286056
Title
5 Batch Analysis Report (Active)
Study date
17 October 2022
Auth party contact address
Level 1, 93 Bolt Road TAHUNANANUI NELSON New Zealand
Data no
286057
Title
Declaration of Composition for reference
Study date
17 October 2022
Auth party contact address
Level 1, 93 Bolt Road TAHUNANANUI NELSON New Zealand
Data no
286054
Title
Manufacture Process of GA4/7
Study date
14 April 2025
Auth party contact address
Level 1, 93 Bolt Road TAHUNANANUI NELSON New Zealand
Data no
286055
Title
Declaration of Composition signed
Study date
17 October 2022
Auth party contact address
Level 1, 93 Bolt Road TAHUNANANUI NELSON New Zealand
Data no
286052
Title
Chemistry and Manufacturing
Study date
14 April 2025
Auth party contact address
Level 1, 93 Bolt Road TAHUNANANUI NELSON New Zealand
Date
Application Date
Application No
Application Number
148197
Product/Active constituent Name
Application Product Name
Ulcesium 50 mg/mL Omeprazole Paste For Horses
Application Date
Application Number
148197
Application Product Name
Ulcesium 50 mg/mL Omeprazole Paste For Horses
Application details
Product name:
Ulcesium 50 mg/mL Omeprazole Paste For Horses
Product number:
96111
Applicant Name:
NAUTS EQUINE PTY LTD
Application purpose and description of use:
Registration of a 50 mg/mL omeprazole oral paste product for the treatment of gastric ulcers in horses and foals.
Reference details:
58757 - GASTROZOL DAILY ORAL PASTE FOR HORSES
Active constituents:
Active constituent name
83049 - Omeprazole 20%
Description of data provided:
Data no
285359
Title
Active Constituent CoA
Study date
2024
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285370
Title
AM040 Ulcesium Finished Product Analytical Method Ed2
Study date
2024
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285371
Title
App 2.13 - Validation of microbiological testing
Study date
2020
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285373
Title
MVP035 Method Validation Protocol - Assay Ed.1
Study date
2024
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285374
Title
MVR035 Method Validation report assay
Study date
2024
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285375
Title
MVP036 Method Validation Protocol RS Testing Ed.1
Study date
2024
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285376
Title
MVR036 Method Validation Report Related Substances
Study date
2024
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285369
Title
Batch analysis CoAs
Study date
2024
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285363
Title
BPS018 Ulcesium PV B241036 executed
Study date
2024
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285364
Title
BPS for Ulcesium 241037 and 241038
Study date
2024
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285365
Title
VAR121 Process Validation Report Ed 2
Study date
2024
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285366
Title
VAP079 Validation protocol for Ulcesium 241036
Study date
2024
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285367
Title
Manufacturing process flow chart
Study date
2025
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285360
Title
Calculation table as per the BPS
Study date
2025
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285361
Title
Calculation table in full
Study date
2025
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285349
Title
Finished product specification
Study date
2025
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285362
Title
Excipient CoAs
Study date
2025
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285368
Title
Packaging specifications
Study date
2025
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285358
Title
2025-04-16 - Ulcesium - Part 2 Chemistry Summary - FINAL
Study date
2025
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285372
Title
Method transfer of Ulcesium
Study date
2025
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285377
Title
SR002 Ulcesium Stability report Ed 3
Study date
2025
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285378
Title
Microbial testing results Ulcesium
Study date
2025
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285379
Title
Appearance pics 241036
Study date
2025
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285380
Title
Appearance pics 241037 and 241038
Study date
2025
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285381
Title
Comparative stability study
Study date
2025
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285384
Title
Bioequivalence of two omeprazole oral paste formulations in the horse. Study report 116NEEBeq.
Study date
2016
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285385
Title
Scientific justification for bioequivalence of Ulcerquine 50 mg/mL Omperazole Paste for Horses.
Study date
2016
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285386
Title
A study to determine the bioequivalence of a test formulation of omeprazole paste versus a registered product in the horse. Study report 217NB.
Study date
2017
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285387
Title
A study to determine the efficacy of a test formulation of omeprazole paste in the treatment and prevention of equine gastric ulcers when compared to a registered product in the horse. Study report 118NOC.
Study date
2018
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285388
Title
A study to determine the efficacy of a test formulation of omeprazole paste in the treatment and prevention of equine gastric ulcers when compared to a registered product in the horse. Study report 218NOC.
Study date
2018
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285389
Title
Investigation of non-inferiority of a test formulation of omeprazole paste in the treatment and prevention of equine gastric ulcers, compared to a registered product, across two studies.
Study date
2020
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285390
Title
Committee for Veterinary Medicinal Products ??? Omeprazole ??? Summary Report. EMEA/ MRL/841/02-FINAL.
Study date
2002
Auth party contact address
-
Data no
285391
Title
Pharmacokinetics and tolerability of a new formulation of omeprazole in the horse.
Study date
2017
Auth party contact address
-
Data no
285392
Title
Monographs for excipients
Study date
2009
Auth party contact address
-
Data no
285393
Title
Omoguard Paste for Horses Safety Data Sheet.
Study date
2016
Auth party contact address
-
Data no
285394
Title
Chemical analysis of reference product
Study date
2020
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285382
Title
Ulcesium - Part 8 Efficacy and Safety Summary - FINAL
Study date
2020
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285383
Title
ECEIM Consensus Statement - Equine Gastric Ulcer Syndrome in Adult Horses
Study date
2015
Auth party contact address
-
Data no
285345
Title
Ulcerquine - PAA final response
Study date
2016
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285346
Title
Ulcerquine - item 25 final response
Study date
2017
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285347
Title
Ulcesium - PAA 141291 - Final advice
Study date
2023
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285348
Title
2025-04-16 - Ulcesium - Regulatory Overview - FINAL
Study date
2025
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285350
Title
Response to notice 1
Study date
2021
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285351
Title
APVMA Notice 1
Study date
2021
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285352
Title
Response to notice 2
Study date
2022
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285353
Title
Response to notice 3
Study date
2023
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285354
Title
APVMA Notice 2
Study date
2023
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285355
Title
2023-12-05 - Final PAA meeting record and written advice - 141291
Study date
2023
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285356
Title
Efficacy and safety report
Study date
2021
Auth party contact address
12A Morris Rd. Croydon Australia
Data no
285357
Title
Chemistry Report
Study date
2023
Auth party contact address
12A Morris Rd. Croydon Australia
Date
Application Date
Application No
Application Number
148289
Product/Active constituent Name
Application Product Name
Randlab Dex 5 mg/mL Injection
Application Date
Application Number
148289
Application Product Name
Randlab Dex 5 mg/mL Injection
Application details
Product name:
Randlab Dex 5 mg/mL Injection
Product number:
89900
Applicant Name:
RANDLAB AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration to obtain the approval for addition of the 100mL Amber glass vial pack size, in addition to the currently approved 50mL Amber glass vial pack size.
Active constituents:
Active constituent name
87297 - Dexamethasone Sodium Phosphate
Description of data provided:
Data no
291344
Title
EMEA Sumary Report 1: Dexamethasone-summary report 1-committee-veterinary medicinal products (1996)
Study date
01/01/1996
Auth party contact address
-
Data no
291345
Title
EMEA: Summary Report 2: Dexamethasone summary report 2-committe-veterinary medicinal products (1997)
Study date
01/01/1997
Auth party contact address
-
Data no
291346
Title
Dexamethasone: Wiley Publications, Veterinary Drug Handbook Seventh Edition
Study date
01/01/1990
Auth party contact address
-
Data no
291347
Title
Method Validation for active ingredient
Study date
30/04/2023
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291348
Title
Broached vial studies with Randlab Dex 5 Injection
Study date
02/11/2021
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291349
Title
Surface area calculation
Study date
21/08/2025
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291350
Title
Method validation for the preservative
Study date
31/05/2023
Auth party contact address
71 Milperra Road Revesby Australia
Data no
285564
Title
Finished Product Specification
Study date
30/06/2020
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291351
Title
Accelerated Stability studies report (3)
Study date
29/06/2020
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291352
Title
Stability studies report 36 months (3)
Study date
13/01/2022
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291353
Title
Stability study report (3)
Study date
25/10/2022
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291354
Title
Pharmacokinetics of dexamethasone following intra-articular, intravenous, intramuscular and oral administration in horses and its effects on endogenous hydrocortisone
Study date
01/09/2012
Auth party contact address
-
Data no
291355
Title
Eudralink
Study date
01/01/2020
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291356
Title
Dexamethasone and prednisolone in the horse: Pharmacokinetics and action on the adrenal gland.
Study date
13/05/1983
Auth party contact address
-
Data no
291357
Title
Manufacturing Declaration Form
Study date
29/08/2025
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291358
Title
s159 Cover Letter and Response Discussion
Study date
2025
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291359
Title
Chemistry Report
Study date
01/11/2022
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291360
Title
APVMA emails
Study date
01/07/2025
Auth party contact address
71 Milperra Road Revesby Australia
Data no
291361
Title
Notice of variation
Study date
10/02/2023
Auth party contact address
71 Milperra Road Revesby Australia
Date
Application Date
Application No
Application Number
148160
Product/Active constituent Name
Application Product Name
Kenso Agcare Amizon Herbicide
Application Date
Application Number
148160
Application Product Name
Kenso Agcare Amizon Herbicide
Application details
Product name:
Kenso Agcare Amizon Herbicide
Product number:
96097
Applicant Name:
KENSO CORPORATION (M) SDN. BHD.
Application purpose and description of use:
Registration of a 300 g/L TRICLOPYR present as butoxyethyl ester, 100 g/L PICLORAM present as hexyloxypropylamine salt and 8 g/L AMINOPYRALID present as hexyloxypropyalmine salt in emulsifiable concentrate product for control of a range of environmental and noxious woody and herbaceous weeds.
Reference details:
60830 - GRAZON EXTRA HERBICIDE
Active constituents:
Active constituent name
53104 - TRICLOPYR BUTOXYETHYL ESTER
Active constituent name
87100 - Picloram
Active constituent name
88366 - Aminopyralid
Description of data provided:
Data no
285808
Title
2 1 COA of Active Ingredient
Study date
20/11/2020
Auth party contact address
B-9-3, PJ8, BLOCK B WEST NO. 23 JALAN BARAT SEKSYEN 8 46050 PETALING JAYA SELANGOR DARUL EHSAN DARUL EHSAN Malaysia
Data no
285811
Title
2 4 Analytical Method and Validation Data for Triclopyr BEE
Study date
20/11/2020
Auth party contact address
B-9-3, PJ8, BLOCK B WEST NO. 23 JALAN BARAT SEKSYEN 8 46050 PETALING JAYA SELANGOR DARUL EHSAN DARUL EHSAN Malaysia
Data no
285812
Title
2 4 Analytical method and Validation Data for Aminopyralid + Picloram
Study date
20/11/2020
Auth party contact address
B-9-3, PJ8, BLOCK B WEST NO. 23 JALAN BARAT SEKSYEN 8 46050 PETALING JAYA SELANGOR DARUL EHSAN DARUL EHSAN Malaysia
Data no
285807
Title
2 0 Chemistry and Manufacturer dossier
Study date
20/11/2020
Auth party contact address
B-9-3, PJ8, BLOCK B WEST NO. 23 JALAN BARAT SEKSYEN 8 46050 PETALING JAYA SELANGOR DARUL EHSAN DARUL EHSAN Malaysia
Data no
285809
Title
2 2 SDS of Inert ingredients
Study date
20/11/2020
Auth party contact address
B-9-3, PJ8, BLOCK B WEST NO. 23 JALAN BARAT SEKSYEN 8 46050 PETALING JAYA SELANGOR DARUL EHSAN DARUL EHSAN Malaysia
Data no
285810
Title
2 3 Stability report Amizon
Study date
20/11/2020
Auth party contact address
B-9-3, PJ8, BLOCK B WEST NO. 23 JALAN BARAT SEKSYEN 8 46050 PETALING JAYA SELANGOR DARUL EHSAN DARUL EHSAN Malaysia
Data no
285813
Title
Part 8 Efficacy and Crop Safety
Study date
07/04/2025
Auth party contact address
B-9-3, PJ8, BLOCK B WEST NO. 23 JALAN BARAT SEKSYEN 8 46050 PETALING JAYA SELANGOR DARUL EHSAN DARUL EHSAN Malaysia
Data no
285814
Title
Bioequivalence of kenso Triclopyr/Picloram/Aminopyralid for controlloing fireweed
Study date
September 2022
Auth party contact address
B-9-3, PJ8, BLOCK B WEST NO. 23 JALAN BARAT SEKSYEN 8 46050 PETALING JAYA SELANGOR DARUL EHSAN DARUL EHSAN Malaysia
Data no
285815
Title
The Bioequivalence of Amizon herbicide for controlling Gorse
Study date
Feb 2023
Auth party contact address
B-9-3, PJ8, BLOCK B WEST NO. 23 JALAN BARAT SEKSYEN 8 46050 PETALING JAYA SELANGOR DARUL EHSAN DARUL EHSAN Malaysia
Date
Application Date
Application No
Application Number
148378
Product/Active constituent Name
Application Product Name
DILIGENT EXTRA SPRAY-ON SHEEP BLOWFLY TREATMENT
Application Date
Application Number
148378
Application Product Name
DILIGENT EXTRA SPRAY-ON SHEEP BLOWFLY TREATMENT
Application details
Product name:
DILIGENT EXTRA SPRAY-ON SHEEP BLOWFLY TREATMENT
Product number:
92035
Applicant Name:
ALLEVA ANIMAL HEALTH LTD
Application purpose and description of use:
Variation of product registration and label approval to vary relevant particulars.
Active constituents:
Active constituent name
92110 - Dicyclanil
Date
Application Date
Application No
Application Number
148380
Product/Active constituent Name
Application Product Name
Flea Shield Salon Shine Cleanser for control of fleas, lice and aids control of adult brown dog ticks suitable for dogs, cats, puppies and kittens
Application Date
Application Number
148380
Application Product Name
Flea Shield Salon Shine Cleanser for control of fleas, lice and aids control of adult brown dog ticks suitable for dogs, cats, puppies and kittens
Application details
Product name:
Flea Shield Salon Shine Cleanser for control of fleas, lice and aids control of adult brown dog ticks suitable for dogs, cats, puppies and kittens
Applicant Name:
RUFUS & COCO PTY. LTD.
Application purpose and description of use:
Registration of a 10 g/L piperonyl butoxide and 1 g/L pyrethrins shampoo for the control of fleas and lice and assistance in control of ticks in dogs, cats, puppies and kittens.
Date
Application Date
Application No
Application Number
147987
Product/Active constituent Name
Application Product Name
NOBIVAC CANINE ORAL Bb LIVE VACCINE
Application Date
Application Number
147987
Application Product Name
NOBIVAC CANINE ORAL Bb LIVE VACCINE
Application details
Product name:
NOBIVAC CANINE ORAL Bb LIVE VACCINE
Product number:
87083
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product registration to add an alternate site of diluent manufacture.
Active constituents:
Active constituent name
89980 - Bordetella Bronchiseptica (Live), Strain B-C2
Description of data provided:
Data no
284595
Title
Flow chart - Diluent
Study date
2024
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
284594
Title
APVMA Overseas site GMP compliance certificate
Study date
20 January 2025
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Date
Application Date
Application No
Application Number
148233
Product/Active constituent Name
Application Product Name
ULTRO 900 WG Herbicide
Application Date
Application Number
148233
Application Product Name
ULTRO 900 WG Herbicide
Application details
Product name:
ULTRO 900 WG Herbicide
Product number:
87234
Applicant Name:
ADAMA AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product registration and label approval to add additional weeds and update the directions for use.
Reference details:
90958 - ULTRO 600 WG Herbicide
Active constituents:
Active constituent name
86709 - Carbetamide
Description of data provided:
Data no
286144
Title
Evaluation of ADM.01250.H.5.D and AD-AU-2301 for control of grass weeds in lupins, York, Western Australia 2023.
Study date
19 February 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286145
Title
Efficacy of Ultro 900 WG at split applications for annual ryegrass (Lolium rigidum) control in lentil cv. Hallmark XT, Strathalbyn, South Australia, 2023.
Study date
1 February 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286146
Title
Evaluation of Ultro 900 WG for the control of paradoxa grass in chickpeas. Report of trial conducted near Millmerran, Queensland.
Study date
30 January 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286147
Title
Evaluation of Ultro 900 WG for the control of wild oats in chickpeas. Report of trial conducted near Millmerran, Queensland.
Study date
27 January 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286148
Title
Efficacy of Ultro 900 WG, applied pre-emergent, for grass weed control in lentil cv. Hurricane, Kapinnie, South Australia, 2023.
Study date
20 February 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286149
Title
Evaluation of Ultro 900 WG, applied in both knife point and disc sowing systems. West Casuarinas, Western Australia, 2023.
Study date
29 September 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286150
Title
Bioequivalence of ADM 01250.H.5.A and Ultro in faba beans. Bridgewater, Victoria, 2021.
Study date
7 March 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286151
Title
Evaluation of Ultro and Tank Mixtures with Grass Selectives when Applied Post-Emergent in Lupins Using a Disc System. Wittenoom Hills, Western Australia, 2021.
Study date
15 December 2021
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286152
Title
Evaluation of Ultro 900 WG for the control of Paradoxa grass in chickpeas. Kincora, Queensland, 2024.
Study date
28 September 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286153
Title
Evaluation of Ultro 900 WG for the control of Wild oats in chickpeas. Millmerran, Queensland, 2025.
Study date
25 February 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286154
Title
Evaluation of Ultro 900 WG for the control of Phalaris in chickpeas. Garah, New South Wales, 2025.
Study date
12 March 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286155
Title
Efficacy of Ultro 900 WG for control of grasses and broadleaf weeds in faba beans cv Bendoc. Sandergrove, South Australia, 2024.
Study date
28 November 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286156
Title
Evaluation of AD-AU-2207 in pulses. Mount Horner, Western Australia, 2024.
Study date
16 December 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286131
Title
ULTRO 900 WG Herbicide - Part 8 Efficacy and Safety
Study date
April 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286132
Title
Evaluation of AG-C4-900 WG, applied at split timings, for the control of monocot weeds in lentils cv. Hurricane, Roseworthy, South Australia, 2017.
Study date
8 August 2018
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286133
Title
Evaluation of split application timings for AG-C4-900 WG on annual ryegrass in lupins, Meckering, Western Australia 2017.
Study date
13 February 2018
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286134
Title
Efficacy and crop safety of ULTRO 900 WG for grass and broadleaf weed control, when applied in a knifepoint press wheel or disc planting system, in chickpeas and lentils, Temora, New South Wales, 2019.
Study date
18 August 2020
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286135
Title
Efficacy of ULTRO 900 WG for control of grass and broadleaf weeds in lentil cv. Hurricane and field pea cv. Butler, Templers, South Australia, 2019.
Study date
25 March 2020
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286137
Title
Evaluation of AD-AU-2204 applied in split applications, IBS followed by PSPE, for pre-emergence weed control in lupins, West Casuarinas, Western Australia, 2022.
Study date
1 December 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286138
Title
Efficacy of AD-AU-2204 800 WG, applied in split applications for control of annual ryegrass (Lolium rigidum) in faba beans cv. Bendoc. Milang, South Australia, 2022.
Study date
30 March 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286139
Title
Comparison of ULTRO 800 WG (AD-AU-2204) and standard herbicides on annual ryegrass and bromegrass in Faba Beans.
Study date
9 April 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286140
Title
Evaluation of ADM.06800.H.1.D applied in split applications, IBS followed by EPE, for pre-emergence weed control in lentils.
Study date
30 March 2023
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286141
Title
Evaluation of AD-AU-2204 applied in split applications, IBS followed by PSPE, for pre-emergence weed control in lupins, Doodenanning, Western Australia 2022.
Study date
2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286142
Title
Evaluation of AD-AU-2204 applied in split applications, IBS followed by PSPE, for pre-emergent weed control in lupins, Kojonup, Western Australia 2022.
Study date
8 January 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286157
Title
ULTRO 900 WG Herbicide Current Label. APVMA Approval No: 87234/117806.
Study date
1 October 2020
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286158
Title
Rustler Selective Label. APVMA Approval No: 61360/141095.
Study date
6 September 2023
Auth party contact address
-
Data no
286159
Title
Terbyne Xtreme Label. APVMA Approval No: 68613/139753.
Study date
19 May 2023
Auth party contact address
-
Data no
286160
Title
Overwatch Label. APVMA Approval No: 86427/138913.
Study date
11 August 2023
Auth party contact address
-
Data no
286161
Title
ULTRO 900 WG Herbicide Draft Label.
Study date
19 April 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286143
Title
Crop safety of AD-AU-2301 800 WG, ADM.01250.H.5.D 800 WG and AD-AU-2207 500 WG in various pulse crops, Belalie North, South Australia, 2023.
Study date
1 January 2024
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286136
Title
Evaluation of Ultro and tank mixtures with grass selective herbicides when applied post-emergence in Lupins, Wongan Hills, Western Australia, 2021.
Study date
9 August 2022
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Data no
286130
Title
Consent for use of information with limitation on use.
Study date
19 April 2025
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Date
Application Date
Application No
Application Number
148305
Product/Active constituent Name
Application Product Name
Sabakem Tebuthiuron 200 GR Herbicide
Application Date
Application Number
148305
Application Product Name
Sabakem Tebuthiuron 200 GR Herbicide
Application details
Product name:
Sabakem Tebuthiuron 200 GR Herbicide
Product number:
88030
Applicant Name:
SABAKEM PTY LTD
Application purpose and description of use:
Variation of the label approval to extend the use to other states in certain situations
Reference details:
69043 - FARMALINX CLEARVIEW 200 GR HERBICIDE
Active constituents:
Active constituent name
57776 - TEBUTHIURON
Active constituent name
68083 - TEBUTHIURON
Description of data provided:
Data no
286234
Title
Executive Summary
Study date
April 2025
Auth party contact address
Suite 809, Level 8, 2 Queen Street Melbourne Australia
Date
Application Date
Application No
Application Number
148267
Product/Active constituent Name
Application Product Name
ATLAS Kill and Protect High Performance Handi Reach Crawling Insect Spray
Application Date
Application Number
148267
Application Product Name
ATLAS Kill and Protect High Performance Handi Reach Crawling Insect Spray
Application details
Product name:
ATLAS Kill and Protect High Performance Handi Reach Crawling Insect Spray
Product number:
84895
Applicant Name:
PASCOE'S PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to add insect pests to statemnent of claims and directions for use
Reference details:
86268 - Atlas Kill & Protect High Performance Crawling Insect Spray
Active constituents:
Active constituent name
51810 - CYPERMETHRIN
Active constituent name
50876 - IMIPROTHRIN MANUFACTURING CONCENTRATE
Date
Application Date
Application No
Application Number
148427
Product/Active constituent Name
Application Product Name
Pyriproxyfen
Application Date
Application Number
148427
Application Product Name
Pyriproxyfen
Application details
Product name:
Pyriproxyfen
Active name:
Pyriproxyfen
Applicant Name:
HEMANI AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of Pyriproxyfen for use in agricultural and Veterinary chemical products.
Description of data provided:
Data no
286163
Title
Appendix 2.1 - Manufacturing process of Pyriproxyfen Technical_Hemani, India
Study date
28/04/2025
Auth party contact address
Suite 516 2-8 Brookhollow Avenue Norwest Australia
Data no
286166
Title
Appendix 2.4 - Hemani_AG-G2012_FR_FiveBatch_ADV
Study date
18/10/2023
Auth party contact address
Suite 516 2-8 Brookhollow Avenue Norwest Australia
Data no
286164
Title
Appendix 2.2 - DECLARATION OF COMPOSITION_Pyriproxyfen Technical_Hemani
Study date
28/04/2025
Auth party contact address
Suite 516 2-8 Brookhollow Avenue Norwest Australia
Data no
286165
Title
Appendix 2.3 - Pyriproxyfen TC-Batch Size Details
Study date
28/04/2025
Auth party contact address
Suite 516 2-8 Brookhollow Avenue Norwest Australia
Data no
286162
Title
Pyriproxyfen AC Part 2 Chemistry and Manufacture - Hemani, India
Study date
28/04/2025
Auth party contact address
Suite 516 2-8 Brookhollow Avenue Norwest Australia