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
150562
Product/Active constituent Name
Application Product Name
Agro-Essence Propyzamide 500 WG Herbicide
Application Date
Application Number
150562
Application Product Name
Agro-Essence Propyzamide 500 WG Herbicide
Application details
Product name:
Agro-Essence Propyzamide 500 WG Herbicide
Product number:
96745
Applicant Name:
THEYES MANAGEMENT PTY LTD
Application purpose and description of use:
Registration of a 500 g/Kg Propyzamide water dispersible granule (WG) for selective control of certain grasses and broadleaf weeds in lettuce, sports turf, home lawns and legume seed crops and pastures.
Reference details:
64641 - AGRISMART PROPYZAMIDE WG HERBICIDE
Active constituents:
Active constituent name
93150 - Propyzamide
Date
Application Date
Application No
Application Number
150797
Product/Active constituent Name
Application Product Name
Owtbac Moxidone Long Acting Injection for Cattle
Application Date
Application Number
150797
Application Product Name
Owtbac Moxidone Long Acting Injection for Cattle
Application details
Product name:
Owtbac Moxidone Long Acting Injection for Cattle
Applicant Name:
THE UNITED ANIMAL HEALTHCARE (INNER MONGOLIA) CO., LTD.
Application purpose and description of use:
Registration of a 100 mg/mL moxidectin injectable product for the treatment and control of moxidectin sensitive internal and external parasites in cattle.
Date
Application Date
Application No
Application Number
150798
Product/Active constituent Name
Application Product Name
Lincomycin hydrochloride
Application Date
Application Number
150798
Application Product Name
Lincomycin hydrochloride
Application details
Product name:
Lincomycin hydrochloride
Active name:
Lincomycin hydrochloride
Applicant Name:
PHIBRO ANIMAL HEALTH PTY LIMITED
Application purpose and description of use:
Approval of lincomycin hydrochloride for use in veterinary chemical products.
Description of data provided:
Data no
295423
Title
Certificates of analysis
Study date
2025
Auth party contact address
Suite 416 / 14-16 Lexington Drive Bella Vista Australia
Data no
295424
Title
Monograph
Study date
2017
Auth party contact address
Suite 416 / 14-16 Lexington Drive Bella Vista Australia
Data no
295425
Title
Certificate
Study date
2021
Auth party contact address
Suite 416 / 14-16 Lexington Drive Bella Vista Australia
Date
Application Date
Application No
Application Number
150524
Product/Active constituent Name
Application Product Name
Bromadiolone
Application Date
Application Number
150524
Application Product Name
Bromadiolone
Application details
Product name:
Bromadiolone
Active name:
Bromadiolone
Applicant Name:
PELGAR INTERNATIONAL (AUS) PTY LTD
Application purpose and description of use:
Approval of bromadiolone for use in agricultural chemical products.
Description of data provided:
Data no
295536
Title
Bromadiolone TG ??? 5 batch analysis
Study date
12/06/2023
Auth party contact address
NORTHBANK PLAZA LEVEL 22, 69 ANN STREET BRISBANE Australia
Data no
295537
Title
Analysis of five batches of bromadiolone and specified impurities, moisture content and associated validation, in compliance with good laboratory practice
Study date
29/06/2011
Auth party contact address
NORTHBANK PLAZA LEVEL 22, 69 ANN STREET BRISBANE Australia
Data no
295538
Title
Method of manufacture (bromadiolone TG)
Study date
02/10/2025
Auth party contact address
NORTHBANK PLAZA LEVEL 22, 69 ANN STREET BRISBANE Australia
Data no
295539
Title
Batch composition information
Study date
08/10/2025
Auth party contact address
NORTHBANK PLAZA LEVEL 22, 69 ANN STREET BRISBANE Australia
Data no
295540
Title
Part 2 Summary
Study date
October 2025
Auth party contact address
NORTHBANK PLAZA LEVEL 22, 69 ANN STREET BRISBANE Australia
Date
Application Date
Application No
Application Number
149982
Product/Active constituent Name
Application Product Name
Efficon Insecticide
Application Date
Application Number
149982
Application Product Name
Efficon Insecticide
Application details
Product name:
Efficon Insecticide
Product number:
90474
Applicant Name:
BASF AUSTRALIA LTD.
Application purpose and description of use:
Variation of product registration label approval to add additional uses
Active constituents:
Active constituent name
90462 - Dimpropyridaz
Description of data provided:
Data no
292934
Title
PAA Meeting Record
Study date
November 2024
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292955
Title
Metabolism of 14C BAS 550 I in lettuce after drench application
Study date
2021-11-24
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292988
Title
Dimpropyridaz (BAS 550 I) - Document M-CA, Section 4 - Analytical Methods
Study date
2025-08-13
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292935
Title
Validation of analytical method L0376/05 for the determination of M550I014 (Reg.No. 6127201) and Reg.No. 6123135 in high water matrices
Study date
2022-05-05
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292936
Title
Validation of BASF Analytical Method L0449/03 for the Determination of BAS 550 I and its Metabolites in Animal Matrices
Study date
2022-01-13
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292977
Title
Determination of BAS 550 I and its metabolites in Eggs and Tissues of Laying Hens following Multiple Oral Administration of BAS 550 I
Study date
2022-01-06
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292978
Title
Determination of BAS 550 I and its metabolites in Milk and Tissues of Dairy Cows following Multiple Oral Administration of BAS 550 I
Study date
2021-12-10
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292979
Title
1st Amendment TO REPORT Determination of BAS 550 I and its metabolites in Milk and Tissues of Dairy Cows following Multiple Oral Administration of BAS 550 I
Study date
2022-02-23
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292980
Title
Determination of BAS 500 I metabolite M550I005 in animal matrices by LC-MS/MS according to BASF analytical method L0449/04
Study date
2022-12-06
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292981
Title
Determination of BAS 550 I metabolite M550I005 in animal matrices by LC-MS/MS according to BASF analytical method L0449/04
Study date
2023-02-28
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292987
Title
Study on the residue behaviour of BAS 550 I (Dimpropyridaz) in the rotational crops: spinach and lettuce (seeded) after one application of BAS 550 01 I to bare soil, 30 +-1 days prior to seeding under field conditions in Northern and Southern Europe, 2021
Study date
2022-05-12
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292957
Title
Field report - Determination of residues of dimpropyridaz and its metabolites in pome fruit following two applications of BAS 550 01 I
Study date
2022-10-17
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292958
Title
Analytical Phase Report - Determination of residues of dimpropyridaz and its metabolites in pome fruit following two applications of BAS 550 01 I
Study date
2022-08-12
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292959
Title
Study on the residue analysis of BAS 550 I (Dimpropyridaz) and its metabolites in plant specimens from different field residue trials (season 2021/2022) after application of BAS 550 01 I
Study date
2023-10-26
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292960
Title
Determination of residues of BAS 550 I, metabolites and two additional analytes in pome fruit following two foliar applications of BAS 550 01 I
Study date
2024-07-09
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292961
Title
Study on the residue analysis of BAS 550 I (Dimpropyridaz) and its metablites in plant specimens from different field residue trials (season 2022/2023) after application of BAS 550 01 I
Study date
2024-07-29
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292962
Title
Determination of residues of BAS 550 I, metabolites and two additional analytes in citrus peel and pulp following two foliar applications of BAS 550 01 I
Study date
2023-12-18
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292963
Title
Study on the residue analysis of BAS 550 I (Dimpropyridaz) and its metabolites in plant specimens from different field residue trials (season 2022/2023) after application of BAS 550 01 I
Study date
2024-07-29
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292964
Title
Determination of residues of Dimpropyridaz and its metabolites in citrus following foliar applications of BAS 550 01 I
Study date
2024-12-12
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292965
Title
Study on the residue analysis of BAS 550 I (Dimpropyridaz) and its metabolites in plant specimens from different field residue trials (season 2024) after application of BAS 550 01 I
Study date
2025-07-17
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292966
Title
Determination of Residues of BAS 550 and metabolites in stone fruit following two foliar applications of BAS 550 01 I
Study date
2023-10-09
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292967
Title
Determination of residues of Dimpropyridaz and its metabolites in stone fruit following two foliar applications of BAS 550 01 I
Study date
2024-07-11
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292968
Title
Determination of residues of BAS 550 I, Metabolites and two additional analytes in wine grapes and table grapes following two foliar applications of BAS 550 01 I - Australis, 2022-2024
Study date
2024-05-24
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292969
Title
Field report - Determination of residues of dimpropyridaz and its metabolites in wine and table grapes following two applications of BAS 550 01 I
Study date
2022-10-17
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292970
Title
Analytical Phase Report - Determination of residues of dimpropyridaz and its metabolites in wine and table grapes following two applications of BAS 550 01 I
Study date
2022-12-08
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292971
Title
Determination of residues of dimpropyridaz following two foliar applications of Efficon Insecticide in wine grapes, table grapes, and wine
Study date
2024-09-25
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292972
Title
Determination of residues of BAS 550 and metabolites in mango following two foliar applications of BAS 550 01 I - Australia, 2022-2023
Study date
2023-10-18
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292973
Title
Determination of residues of Dimpropyridaz and its metabolites in mango following two foliar applications of BAS 550 01 I
Study date
2024-07-11
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292974
Title
Field report - Determination of residues of dimpropyridaz and its metabolites in potatoes following four applications of BAS 550 01 I
Study date
2022-10-17
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292975
Title
Analytical Phase Report - Determination of residues of dimpropyridaz and its metabolites in potatoes following four applications of BAS 550 01 I
Study date
2022-08-12
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292976
Title
Determination of residues of BAS 550 I, metabolites and two additional analytes in potato following four foliar applications of BAS 550 01 I
Study date
2023-11-29
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292937
Title
Final Report: Investigation of the storage stability of BAS 550 I and its metabolite Reg. No. 5934514 (M550I004) in plant and bee related matrices
Study date
2022-12-15
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292938
Title
Final Report: Investigation of the storage stability of BAS 550 I and its Metabolite M550I004 (Reg. No. 5934514) in plant matrices
Study date
2022-11-24
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292939
Title
Final Report: Storage Stability of BAS 550 I and M550I004 in plant and processing matrices under Deep Frozen Conditions
Study date
2023-08-30
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292940
Title
Final Report: Investigation of the storage stability of M550I002, M550I005 and M550I006 in high water matrices
Study date
2024-03-01
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292941
Title
Final Report: Frozen Storage Stability of M550I002, M550I005 and M550I006 in Plant, Processing and Bee Matrices
Study date
2023-11-29
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292942
Title
Final Report: Investigation of the storage stability of BAS 550I, M550I002, M550I004 and M550I006 in lettuce
Study date
2021-05-27
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292943
Title
Final Report: Investigation of the storage stability of BAS 550 I, M550I002, M550I004 and M550I006 in lettuce
Study date
2023-12-11
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292944
Title
Final Report: Investigation of the storage stability of BAS 550 I, M550I002, M550I004, M550I005 and M550I006 in cucumbers
Study date
2024-01-31
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292945
Title
Final Report: Investigation of the storage stability of BAS 550 I, M550I002, M550I004, M550I005 and M550I006 in cucumbers
Study date
2023-12-12
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292946
Title
Final Report: Investigation of the storage stability of BAS 550 I, M550I002, M550I004 and M550I006 in cherries
Study date
2023-09-13
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292947
Title
Final Report: Investigation of the storage stability of BAS 550 I, M550I002, M550I004 and M550I006 in cherries
Study date
2023-12-12
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292948
Title
Final Report: Storage Stability of M550I002 in High Acid Matrices under Deep Frozen Conditions
Study date
2024-02-20
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292949
Title
Final Report: Investigation of the storage stability of M550I014 in high water matrices
Study date
2023-11-07
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292950
Title
Final Report: Investigation of the stability of M550I002 in radish roots after 57 months of storage
Study date
2024-10-30
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292951
Title
Final Report: Investigation of the storage stability of BAS 550 I in carrots
Study date
2024-11-14
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292952
Title
Final Report: Frozen Storage Stability of BAS 550 I and Metabolites in Animal Matrices
Study date
2022-02-01
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292953
Title
Report Amendment No.1: Frozen Storage Stability of BAS 550 I and Metabolites in Animal Matrices
Study date
2022-03-01
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292954
Title
Final Report: Storage stability of M550I005 in animal matrices under deep frozen conditions
Study date
2024-01-25
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292956
Title
Quantitative analysis of the storage stability of lettuce metabolism samples (BASF DocID 2018/1085577 (foliar) and BASF DocID 2019/2049814 (drench).
Study date
2024-12-05
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292982
Title
Study on the residue behaviour of BAS 550 I (Reg.No. 5845955) in orange and its processed fractions after two applications with BAS 550 01 I under field conditions in Spain, 2018
Study date
2021-05-18
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292983
Title
Determination of residues of BAS 550 I (Dimpropyridaz) in apples (Malus domestica BORKH.) and their processed products after two applications of BAS 550 01 I under field conditions in Northern Europe, 2019
Study date
2021-03-09
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292984
Title
Determination of residues of BAS 550 I (Reg.No. 5845955) in grapes (Vitis vinifera) and their processed products after two applications of BAS 550 01 I in Germany, 2018
Study date
2021-04-28
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292985
Title
Determination of BAS 550 I residues in samples from different processing studies
Study date
2022-01-26
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292986
Title
Final Report Amendment No. 1: Determination of BAS 550 I residues in samples from different processing matrices
Study date
2022-05-13
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292989
Title
Dimpropyridaz (BAS 550 I) - Document M-CA, Section 6 - Residues in or on treated Products, Food and Feed and Plant Metabolism
Study date
2025-08-13
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292990
Title
Part 5 Residues and Treade Dossier
Study date
2025
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
292991
Title
XIV.6 OECD Calculator - MRLs - Parent
Study date
2025-08-08
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Date
Application Date
Application No
Application Number
150808
Product/Active constituent Name
Application Product Name
ROBENIDINE HYDROCHLORIDE
Application Date
Application Number
150808
Application Product Name
ROBENIDINE HYDROCHLORIDE
Application details
Product name:
ROBENIDINE HYDROCHLORIDE
Active name:
ROBENIDINE HYDROCHLORIDE
Applicant Name:
PAH AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of robenidine hydrochloride for use in veterinary chemical products.
Description of data provided:
Data no
295457
Title
Certificates of analysis
Study date
2025
Auth party contact address
20 Buontempo Road CARRUM DOWNS Australia
Data no
295459
Title
Declaration
Study date
2025
Auth party contact address
20 Buontempo Road CARRUM DOWNS Australia
Data no
295458
Title
DMF
Study date
2025
Auth party contact address
20 Buontempo Road CARRUM DOWNS Australia
Date
Application Date
Application No
Application Number
150356
Product/Active constituent Name
Application Product Name
KELPIE Pyrox-S 850WG
Application Date
Application Number
150356
Application Product Name
KELPIE Pyrox-S 850WG
Application details
Product name:
KELPIE Pyrox-S 850WG
Product number:
94457
Applicant Name:
SINOCHEM INTERNATIONAL AUSTRALIA PTY. LTD.
Application purpose and description of use:
Variation of product registration to add an additional formulation and to update the product name.
Active constituents:
Active constituent name
91618 - Pyroxasulfone
Date
Application Date
Application No
Application Number
150112
Product/Active constituent Name
Application Product Name
Fumagard Fumigation Tablets
Application Date
Application Number
150112
Application Product Name
Fumagard Fumigation Tablets
Application details
Product name:
Fumagard Fumigation Tablets
Product number:
89708
Applicant Name:
NATIONAL FUMIGANTS PTY LTD
Application purpose and description of use:
Variation of product registration to add an additional formulator with a closely similar formulation
Reference details:
52020 - FUMAPHOS FUMIGATION TABLETS
89708 - Fumagard Fumigation Tablets
Active constituents:
Active constituent name
44298 - ALUMINIUM PHOSPHIDE
Description of data provided:
Data no
293216
Title
Analytical Test Report of Aluminium Phosphide 56% Tablet
Study date
17 January 2023
Auth party contact address
Level 28 AMP Tower 140 St Georges Terrace Perth Australia
Data no
293217
Title
Declaration of Composition
Study date
2025
Auth party contact address
Level 28 AMP Tower 140 St Georges Terrace Perth Australia
Data no
293218
Title
Declaration
Study date
17 July 2025
Auth party contact address
Level 28 AMP Tower 140 St Georges Terrace Perth Australia
Data no
293215
Title
DC12-32906580 Dossier
Study date
16 July 2025
Auth party contact address
Level 28 AMP Tower 140 St Georges Terrace Perth Australia
Data no
293219
Title
Safety Data Sheet
Study date
2025
Auth party contact address
Level 28 AMP Tower 140 St Georges Terrace Perth Australia
Data no
293220
Title
Current Fumagard Fumigation Tablets Label
Study date
2025
Auth party contact address
Level 28 AMP Tower 140 St Georges Terrace Perth Australia
Date
Application Date
Application No
Application Number
150564
Product/Active constituent Name
Application Product Name
Searles Buffalo Master Selective Weedkiller
Application Date
Application Number
150564
Application Product Name
Searles Buffalo Master Selective Weedkiller
Application details
Product name:
Searles Buffalo Master Selective Weedkiller
Applicant Name:
J C & A T SEARLE PTY LTD
Application purpose and description of use:
Registration of a 15 g/L diflufenican, 20 g/L clopyralid present as the olamine salt and 300 g/L MCPA present as the potassium salt as an SC product for the control of certain broadleaf weeds in turf.
Date
Application Date
Application No
Application Number
150484
Product/Active constituent Name
Application Product Name
BOLLGARD 3
Application Date
Application Number
150484
Application Product Name
BOLLGARD 3
Application details
Product name:
BOLLGARD 3
Product number:
69656
Applicant Name:
MONSANTO AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration to amend the Resistance Management Plan as part of the conditions of registration
Active constituents:
Active constituent name
69067 - BACILLUS THURINGIENSIS STRAIN AB88 EXOTOXIN, VIP3A, AS PRODUCED BY VIP3A(A) GENE
Description of data provided:
Data no
295362
Title
Propoed change to Northern resistance management plan 2025/26
Study date
2025-09-12
Auth party contact address
Level 4, 109 Burwood Road Hawthorn Australia
Data no
295363
Title
Resistance Management Plan for Bollgard 3 Cotton for Northern Australia - marked-up version
Study date
2025-10-07
Auth party contact address
Level 4, 109 Burwood Road Hawthorn Australia
Data no
295364
Title
Resistance Management Plan for Bollgard 3 Cotton for Northern Australia
Study date
2025-10-07
Auth party contact address
Level 4, 109 Burwood Road Hawthorn Australia
Date
Application Date
Application No
Application Number
150491
Product/Active constituent Name
Application Product Name
Duotic Ear Gel for Dogs
Application Date
Application Number
150491
Application Product Name
Duotic Ear Gel for Dogs
Application details
Product name:
Duotic Ear Gel for Dogs
Product number:
94699
Applicant Name:
DECHRA LTD
Application purpose and description of use:
Variation of product registration label approval to address conditions of registration.
Active constituents:
Active constituent name
88081 - Terbinafine
Active constituent name
82454 - BETAMETHASONE ACETATE
Description of data provided:
Data no
293232
Title
Terbinafine Certificates of Analysis
Study date
May 2024
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
293233
Title
Betamethasone Acetate Certificates of Analysis
Study date
2025
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
293230
Title
Process Validation Report
Study date
8 January 2025
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Data no
293231
Title
Process Validation Protocol
Study date
6 September 2024
Auth party contact address
DECHRA HOUSE SNAYGILL INDUSTRIAL ESTATE KEIGHLEY ROAD, SKIPTON, NORTH YORKSHIRE BD23 2RW United Kingdom
Date
Application Date
Application No
Application Number
150645
Product/Active constituent Name
Application Product Name
AUTHENCE VIRESTINA
Application Date
Application Number
150645
Application Product Name
AUTHENCE VIRESTINA
Application details
Product name:
AUTHENCE VIRESTINA
Product number:
96779
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 200 g/L metproxybicyclone emulsifiable concentrate product for use in pulses, in conjunction with approval of metproxybicyclone.
Description of data provided:
Data no
294511
Title
Part 2 - Chemistry and Manufacture
Study date
29 September 2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294510
Title
A23434H - Validation of Analytical Method SF-1180/2. Final Report Amendment 2.
Study date
15 August 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294512
Title
A23434H - Chemical Characterization of Batch ID 1279808. Final Report Amendment 1.
Study date
19 March 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294513
Title
Metproxybicyclone - Manufacturing Process Description
Study date
22 September 2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294514
Title
Safety Data Sheets
Study date
18 September 2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294515
Title
A23434H - Physical and Technical Properties of Batch 1279808. Final Report Amendment 1
Study date
06 February 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294516
Title
A23434H - Physico-chemical characteristics of Batch 1279808
Study date
05 December 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294517
Title
A23434H - Determination of Volatility of Batch 1279808 according to ABNT NBR 13238. Final Report Amendment 1
Study date
06 February 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294518
Title
A23434H - Safety Study. Final Report Amendment 1.
Study date
11 April 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294519
Title
A23434H - Oxidation/Reduction: Chemical Incompatibility
Study date
05 December 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294520
Title
A23434H - Storage Stability and Shelf Life Statement (2 Weeks 54 ??C) in Packaging Made of HDPE/PA according to CIPAC MT 46.4
Study date
26 January 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294521
Title
A23434H - Low Temperature Stability of Batch 1279808
Study date
06 February 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294570
Title
Project plan for Item 27 Timeshift Application for A23434H Herbicide
Study date
08 October 2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294522
Title
Part 6 - Occupational Health and Safety
Study date
14 October 2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294523
Title
SYN550023 EC (A23434H) - In Eye Skin Irritation Test in Isolated Chicken Eyes
Study date
08 September 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294524
Title
SYN550023 EC (A23434H) - Acute Eye Irritation Study in Rabbits
Study date
03 October 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294525
Title
SYN550023 EC (A23434H) - Acute Inhalation Exposure (Nose-only) in Rats
Study date
25 January 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294526
Title
SYN550023 EC (A23434H) - Acute Oral Toxicity Study in Rats (Up and Down Procedure)
Study date
20 November 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294527
Title
SYN550023 EC (A23434H) - In Vitro Skin Irritation Test in the EPISKIN??? Model
Study date
08 September 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294528
Title
SYN550023 EC (A23434H) - Acute Dermal Irritation Study in Rabbits
Study date
17 November 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294529
Title
SYN550023 EC (A23434H) - Skin Sensitization Test (Local Lymph Node Assay)
Study date
03 November 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
294530
Title
Part 3 - Toxicology
Study date
29 September 2025
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
150533
Product/Active constituent Name
Application Product Name
IMIDACLOPRID 100 MG/ML + MOXIDECTIN 25 MG/ML SPOT ON SOLUTION FOR DOGS
Application Date
Application Number
150533
Application Product Name
IMIDACLOPRID 100 MG/ML + MOXIDECTIN 25 MG/ML SPOT ON SOLUTION FOR DOGS
Application details
Product name:
IMIDACLOPRID 100 MG/ML + MOXIDECTIN 25 MG/ML SPOT ON SOLUTION FOR DOGS
Product number:
96732
Applicant Name:
ASHISH LIFE SCIENCE PVT. LTD.
Application purpose and description of use:
Registration of a 100 mg/mL imidacloprid, 25 mg/mL moxidectin topical solution for the treatment of fleas, heartworm
and worms in dogs.
Reference details:
55323 - ADVOCATE SPOT-ON FOR DOGS OVER 25KG
Active constituents:
Active constituent name
96734 - MOXIDECTIN
Active constituent name
96724 - Imidacloprid
Description of data provided:
Data no
294276
Title
Product specifications
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
294277
Title
Certificate-2
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Date
Application Date
Application No
Application Number
150521
Product/Active constituent Name
Application Product Name
Imidacloprid
Application Date
Application Number
150521
Application Product Name
Imidacloprid
Application details
Product name:
Imidacloprid
Active name:
Imidacloprid
Applicant Name:
ASHISH LIFE SCIENCE PVT. LTD.
Application purpose and description of use:
New source of pharmacopoeia active constituent
Description of data provided:
Data no
294668
Title
Certificates of analysis
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
294669
Title
Certificate-1
Study date
2022
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Date
Application Date
Application No
Application Number
150495
Product/Active constituent Name
Application Product Name
Macspred Trimac Plus Herbicide
Application Date
Application Number
150495
Application Product Name
Macspred Trimac Plus Herbicide
Application details
Product name:
Macspred Trimac Plus Herbicide
Product number:
84798
Applicant Name:
MACSPRED PTY. LTD.
Application purpose and description of use:
Variation of product registration to seek approval for minor formulation change and to revise the current manufacturing process.
Active constituents:
Active constituent name
66681 - CLOPYRALID
Active constituent name
47043 - SULFOMETURON-METHYL
Active constituent name
64443 - TERBACIL
Date
Application Date
Application No
Application Number
150766
Product/Active constituent Name
Application Product Name
PEXION 400 MG TABLETS FOR DOGS
Application Date
Application Number
150766
Application Product Name
PEXION 400 MG TABLETS FOR DOGS
Application details
Product name:
PEXION 400 MG TABLETS FOR DOGS
Product number:
67812
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Variation of label approval to align with ACVM approved label text.
Active constituents:
Active constituent name
83413 - Imepitoin
Description of data provided:
Data no
295345
Title
Pexion 400 executive summary
Study date
27/10/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date
Application Date
Application No
Application Number
150535
Product/Active constituent Name
Application Product Name
MOXIDECTIN
Application Date
Application Number
150535
Application Product Name
MOXIDECTIN
Application details
Product name:
MOXIDECTIN
Active name:
MOXIDECTIN
Applicant Name:
ASHISH LIFE SCIENCE PVT. LTD.
Application purpose and description of use:
New source of pharmacopeia active constituent
Description of data provided:
Data no
294670
Title
Certificates of analysis
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
294671
Title
Certificate-1
Study date
2024
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Date
Application Date
Application No
Application Number
149974
Product/Active constituent Name
Application Product Name
Bismuth Subnitrate
Application Date
Application Number
149974
Application Product Name
Bismuth Subnitrate
Application details
Product name:
Bismuth Subnitrate
Active name:
Bismuth Subnitrate
Applicant Name:
NORBROOK LABORATORIES AUSTRALIA PTY LIMITED
Application purpose and description of use:
The purpose of this application is to seek approval of an existing active constituent, Bismuth Subnitrate from a new source for use in veterinary chemical product.
Description of data provided:
Data no
293033
Title
CoAs
Study date
2025
Auth party contact address
UNIT 7, 15-21 Butler Way TULLAMARINE Australia
Data no
293034
Title
CoAs
Study date
2025
Auth party contact address
UNIT 7, 15-21 Butler Way TULLAMARINE Australia
Data no
291341
Title
Part 2 Chemistry - Vol 1 of 1.pdf Size (bytes): 20118791
Study date
September 2025
Auth party contact address
UNIT 7, 15-21 Butler Way TULLAMARINE Australia
Data no
291342
Title
Part 2 Chemistry - Vol 1 of 1.pdf Size (bytes): 20118791
Study date
September 2025
Auth party contact address
UNIT 7, 15-21 Butler Way TULLAMARINE Australia
Date
Application Date
Application No
Application Number
150520
Product/Active constituent Name
Application Product Name
IMIDACLOPRID 100 MG/ML + MOXIDECTIN 10 MG/ML SPOT ON SOLUTION FOR CATS
Application Date
Application Number
150520
Application Product Name
IMIDACLOPRID 100 MG/ML + MOXIDECTIN 10 MG/ML SPOT ON SOLUTION FOR CATS
Application details
Product name:
IMIDACLOPRID 100 MG/ML + MOXIDECTIN 10 MG/ML SPOT ON SOLUTION FOR CATS
Product number:
96723
Applicant Name:
ASHISH LIFE SCIENCE PVT. LTD.
Application purpose and description of use:
Registration of a 100 mg/mL imidacloprid, 10 mg/mL moxidectin topical solution for the treatment of fleas, heartworm and worms in cats.
Reference details:
55326 - ADVOCATE SPOT-ON FOR CATS OVER 4KG
Active constituents:
Active constituent name
96724 - Imidacloprid
Active constituent name
96734 - MOXIDECTIN
Description of data provided:
Data no
293467
Title
Product specifications
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
293468
Title
Certificate-2
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Date
Application Date
Application No
Application Number
150737
Product/Active constituent Name
Application Product Name
Esafoxolaner
Application Date
Application Number
150737
Application Product Name
Esafoxolaner
Application details
Product name:
Esafoxolaner
Active name:
Esafoxolaner
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Variation of esafoxolaner for use in veterinary chemical products to add a new source of active.
Description of data provided:
Data no
294760
Title
Validation of Analytical Procedure for the Drug Substance
Study date
29 February 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
294754
Title
Batch Analyses for the Drug Substance
Study date
11 Sep 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
294755
Title
Certificate of Analysis Batch 12
Study date
21 May 2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
294756
Title
Certificate of Analysis Batch 13
Study date
24 May 2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
294757
Title
Certificate of Analysis Batch 14
Study date
27 May 2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
294758
Title
Analytical Procedure for the Drug Substance
Study date
20 Jan 2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
294752
Title
Certifcate of GMP Compliance of a manufacturer
Study date
13/08/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
294753
Title
Specifications for the Drug Substance - Esatoxolaner
Study date
6 May 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
294759
Title
Stability Data - Accelerated and Long-Term Stability Studies for the Drug Substance
Study date
07 Jul 2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia