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
152473
Product/Active constituent Name
Application Product Name
Avilive Triclopyr 600 EC Herbicide
Application Date
Application Number
152473
Application Product Name
Avilive Triclopyr 600 EC Herbicide
Application details
Product name:
Avilive Triclopyr 600 EC Herbicide
Applicant Name:
Zhejiang Avilive Chemical Imp. & Exp. Co., Ltd.
Application purpose and description of use:
Registration of a 600 g/L triclopyr emulsifiable concentrate EC product for the control of a range of woody weeds and melons.
Date
Application Date
Application No
Application Number
152484
Product/Active constituent Name
Application Product Name
Dodine Technical
Application Date
Application Number
152484
Application Product Name
Dodine Technical
Application details
Product name:
Dodine Technical
Active name:
Dodine Technical
Applicant Name:
INDOFIL INDUSTRIES AUSTRALIA PTY. LTD.
Application purpose and description of use:
Approval of dodine for use in agricultural chemical products.
Description of data provided:
Data no
303721
Title
Dodine Executive Summary 0326
Study date
March 2026
Auth party contact address
18 London Court KELLYVILLE Australia
Data no
303724
Title
Five Batch Analysis of Dodine Technical(Volume I and II)
Study date
September 2024
Auth party contact address
18 London Court KELLYVILLE Australia
Data no
303727
Title
Dodine - Part 2-Chemistry 0326
Study date
March 2026
Auth party contact address
18 London Court KELLYVILLE Australia
Data no
303725
Title
Batch Size Declaration
Study date
March 2026
Auth party contact address
18 London Court KELLYVILLE Australia
Data no
303722
Title
Manufacturing Process of Dodine Technical
Study date
February 2026
Auth party contact address
18 London Court KELLYVILLE Australia
Data no
303723
Title
Declaration of Composition
Study date
February 2026
Auth party contact address
18 London Court KELLYVILLE Australia
Data no
303726
Title
Packaging specifications
Study date
March 2026
Auth party contact address
18 London Court KELLYVILLE Australia
Date
Application Date
Application No
Application Number
152400
Product/Active constituent Name
Application Product Name
RX-380 COTTON GROWTH REGULATOR
Application Date
Application Number
152400
Application Product Name
RX-380 COTTON GROWTH REGULATOR
Application details
Product name:
RX-380 COTTON GROWTH REGULATOR
Product number:
89031
Applicant Name:
ADAMA AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product registration to make a minor change to the formulation.
Reference details:
89031 - RX-380 COTTON GROWTH REGULATOR
Active constituents:
Active constituent name
52555 - MEPIQUAT CHLORIDE
Description of data provided:
Data no
303681
Title
Chemistry Data Waiver Request
Study date
5 March 2026
Auth party contact address
Level 1 Building B 207 Pacific Highway St Leonards Australia
Date
Application Date
Application No
Application Number
152428
Product/Active constituent Name
Application Product Name
MaxiMite 500WG Miticide
Application Date
Application Number
152428
Application Product Name
MaxiMite 500WG Miticide
Application details
Product name:
MaxiMite 500WG Miticide
Applicant Name:
EUROCHEM PTY. LTD.
Application purpose and description of use:
Registration of a 500 water dispersible granule formulation of bifenazate for the control of Two-spotted Mite, European Red Mite and Bryobia Mite in Pome Fruit, Stone Fruit and Almonds as indicated in the Directions For Use Table.
Date
Application Date
Application No
Application Number
152472
Product/Active constituent Name
Application Product Name
eChem Glufosinate 800 SG Herbicide
Application Date
Application Number
152472
Application Product Name
eChem Glufosinate 800 SG Herbicide
Application details
Product name:
eChem Glufosinate 800 SG Herbicide
Applicant Name:
ECHEM (AUST) PTY LIMITED
Application purpose and description of use:
Registration of a 880 g/kg Glufosinate-ammonium product for non-residual control of broadleaf and grass weeds in various situations.
Date
Application Date
Application No
Application Number
152454
Product/Active constituent Name
Application Product Name
Titan Ottimo Fungicide
Application Date
Application Number
152454
Application Product Name
Titan Ottimo Fungicide
Application details
Product name:
Titan Ottimo Fungicide
Product number:
97241
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Registration of an emulsifiable concentrate product for the control of varoius diseases in canola, wheat, barley, chickpeas, faba beans, field peas and lentils.
Reference details:
69361 - AVIATOR XPRO FOLIAR FUNGICIDE
Active constituents:
Active constituent name
95217 - Bixafen
Active constituent name
86347 - prothioconazole
Description of data provided:
Data no
303629
Title
Ref. 9 Compare crop safety and efficacy of Titan BU-2301.07, Titan Prothio + Teb and Aviator on spot form and net form net blotch in barley.
Study date
November 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
303621
Title
Ref. 1 Bioequivalence of Titan BU-2310.07 to Aviator Pro for the Control of Blackleg in Canola
Study date
17 December 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
303612
Title
Titan Ottimo Fungicide Chemistry Module 3
Study date
11 March 2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
303632
Title
Ref. 12 Titan Ottimo Fungicide draft label
Study date
12 March 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
303618
Title
Ref. 6 Certificate of Analysis for Bixafen TC
Study date
27 May 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
303615
Title
Ref. 3 Safety Data Sheet for Bixafen Technical Concentrate
Study date
January 2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
303627
Title
Ref. 7 Bioequivalence of Titan BU-2310.07 to Aviator Pro for the Control of Yellow Spot in Wheat
Study date
17 December 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
303616
Title
Ref. 4 Safety Data Sheets for Excipients of Titan Ottimo Fungicide
Study date
March 2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
303630
Title
Ref. 10 Bioequivalence of Titan BU-2310.07 to Aviator Pro for the Control of SFNB in Barley
Study date
17 December 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
303624
Title
Ref. 4 Bioequivalence of Titan BU-2310.07 to Aviator XPro in Upper Canopy Infection Blackleg in Canola
Study date
4 March 2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
303613
Title
Ref. 1 Safety Data Sheet for Titan Ottimo Fungicide
Study date
January 2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
303625
Title
Ref. 5 Efficacy of BU-2310.07 for Controlling Upper Canopy Infection of Leptosphaeria maculans (Blackleg) in Canola
Study date
5 December 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
303619
Title
Ref. 7 Storage Stability Study of Titan Bixafen 75 + Prothioconazole 150 EC.
Study date
25 July 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
303631
Title
Ref. 11 Compare crop safety and efficacy of Titan BU-2301.07 to Aviator on Ascochyta blight control on lentils
Study date
October 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
303622
Title
Ref. 2 Bioequivalence of Titan BU-2310.07 to Aviator XPro in Canola
Study date
4 March 2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
303628
Title
Ref. 8 Evaluation of BU-2310.07 Bioequivalence to Aviator Xpro for Control of Blumeria graminis f. sp. hordei (Barley Powdery Mildew) and Pyrenophora teres f. maculata (Spot Form of Net Blotch) in Barley
Study date
5 December 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
303617
Title
Ref. 5 Certificate of Analysis for Prothioconazole TC
Study date
18 January 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
303623
Title
Ref. 3 Bioequivalence of Titan BU-2310.07 to Aviator Pro for the Control of Upper Canopy Blackleg in Canola
Study date
5 January 2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
303614
Title
Ref. 2 Safety Data Sheet for Prothioconazole Technical Concentrate
Study date
June 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
303626
Title
Ref. 6 Bioequivalence of Titan BU-2310.07 to Aviator Pro for the Control of Sclerotinia in Canola
Study date
17 December 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
303620
Title
Titan Ottimo Fungicide Efficacy and Crop Safety Module 8.2
Study date
11 March 2026
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
152468
Product/Active constituent Name
Application Product Name
Procymidone
Application Date
Application Number
152468
Application Product Name
Procymidone
Application details
Product name:
Procymidone
Active name:
Procymidone
Applicant Name:
GREENCHEM HK LTD
Application purpose and description of use:
Approval of Procymidone for use in agricultural chemical products.
Description of data provided:
Data no
303641
Title
Attachment 2 to 5-Batch analysis for Procymidone TC
Study date
11/10/2025
Auth party contact address
Unit 1002 Perfect Commercial Building 20 Austin Avenue Tsim Sha Tsui, Kowloon Hong Kong
Data no
303644
Title
Manufacturing Process for Procymidone TC
Study date
26/12/2025
Auth party contact address
Unit 1002 Perfect Commercial Building 20 Austin Avenue Tsim Sha Tsui, Kowloon Hong Kong
Data no
303639
Title
5-Batch analysis for Procymidone TC
Study date
11/10/2025
Auth party contact address
Unit 1002 Perfect Commercial Building 20 Austin Avenue Tsim Sha Tsui, Kowloon Hong Kong
Data no
303642
Title
Certificate of analysis
Study date
19/07/2024
Auth party contact address
Unit 1002 Perfect Commercial Building 20 Austin Avenue Tsim Sha Tsui, Kowloon Hong Kong
Data no
303643
Title
Declaration of composition
Study date
20/02/2026
Auth party contact address
Unit 1002 Perfect Commercial Building 20 Austin Avenue Tsim Sha Tsui, Kowloon Hong Kong
Data no
303640
Title
Attachment 1 to 5-Batch analysis for Procymidone TC
Study date
11/10/2025
Auth party contact address
Unit 1002 Perfect Commercial Building 20 Austin Avenue Tsim Sha Tsui, Kowloon Hong Kong
Date
Application Date
Application No
Application Number
152483
Product/Active constituent Name
Application Product Name
Metalaxyl-M
Application Date
Application Number
152483
Application Product Name
Metalaxyl-M
Application details
Product name:
Metalaxyl-M
Active name:
Metalaxyl-M
Applicant Name:
INDOFIL INDUSTRIES AUSTRALIA PTY. LTD.
Application purpose and description of use:
Approval of Metalaxyl-M for use in agricultural chemical products.
Description of data provided:
Data no
303692
Title
Metalaxyl-M - Part 2-Chemistry
Study date
March 2026
Auth party contact address
18 London Court KELLYVILLE Australia
Data no
303690
Title
Batch Size Declaration
Study date
March 2026
Auth party contact address
18 London Court KELLYVILLE Australia
Data no
303687
Title
Manufacturing Process of Metalaxyl-M Technical
Study date
February 2026
Auth party contact address
18 London Court KELLYVILLE Australia
Data no
303688
Title
Declaration of Composition (DoC)
Study date
February 2026
Auth party contact address
18 London Court KELLYVILLE Australia
Data no
303691
Title
Packaging specifications
Study date
March 2026
Auth party contact address
18 London Court KELLYVILLE Australia
Data no
303686
Title
Metalaxyl-M Executive Summary 0326
Study date
February 2026
Auth party contact address
18 London Court KELLYVILLE Australia
Data no
303689
Title
Five batch analysis of Metalaxyl-M technical and its associated impurities
Study date
November 2021
Auth party contact address
18 London Court KELLYVILLE Australia
Date
Application Date
Application No
Application Number
152412
Product/Active constituent Name
Application Product Name
INTUITY FUNGICIDE
Application Date
Application Number
152412
Application Product Name
INTUITY FUNGICIDE
Application details
Product name:
INTUITY FUNGICIDE
Product number:
69787
Applicant Name:
SUMITOMO CHEMICAL AUSTRALIA PTY. LIMITED
Application purpose and description of use:
Variation of label approval for Intuity Fungicide to extend the use to include protected cropping use in cucurbits for the control of powdery mildew.
Active constituents:
Active constituent name
69788 - MANDESTROBIN
Description of data provided:
Data no
303512
Title
Evaluation of fungicides for disease control in cucurbits. Gin Gin, Queensland, 2023. [V23-023-VBC80173-CUC]
Study date
July 2024
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
303509
Title
Intuity Fungicide Part 8 - Efficacy and Crop Safety
Study date
2026
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
303515
Title
Evaluation of fungicides for disease cotnrol in cucurbits. Farnsfield, Queensland, 2021. [F21-017-VBC80173-CUC]
Study date
Jan 2022
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
303510
Title
Evaluation of fungicides for disease control on cucurbits in protected cropping systems. Gin Gin, Queensland, 2024. [V24-003-5233-CUC-PROTECTED]
Study date
May 2025
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
303516
Title
RESIDUES AND TRADE EVALUATION REPORT - 69787 / 137065
Study date
Jan 2023
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
303513
Title
Evaluation of fungicides for disease control in cucurbits. Gin Gin, Queensland, 2020. [F20-13-VBC80173-CUC]
Study date
Feb 2021
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
303514
Title
Evaluation of fungicides for disease control in cucurbits. Gin Gin, Queensland, 2023. [F22-023-VBC80173-CUC]
Study date
Jun 2023
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
303511
Title
Evaluation of fungicides for disease control on cucurbits in protected cropping systems. Gin Gin, Queensland, 2024. [V24-007-5233-CUC-PROTECTED]
Study date
June 2025
Auth party contact address
51 RAWSON STREET EPPING Australia
Data no
303517
Title
Intuity Fungicide Label
Study date
10/03/2026
Auth party contact address
51 RAWSON STREET EPPING Australia
Date
Application Date
Application No
Application Number
152430
Product/Active constituent Name
Application Product Name
Smart Pantheon Fungicide
Application Date
Application Number
152430
Application Product Name
Smart Pantheon Fungicide
Application details
Product name:
Smart Pantheon Fungicide
Product number:
86113
Applicant Name:
CROP SMART PTY LTD
Application purpose and description of use:
Variation of product registration and label approval for Smart Pantheon Fungicide to add an additional pack
size.
Active constituents:
Active constituent name
69183 - AZOXYSTROBIN TECHNICAL
Active constituent name
69930 - CYPROCONAZOLE
Date
Application Date
Application No
Application Number
152244
Product/Active constituent Name
Application Product Name
Sabakem Diquat 200 Herbicide
Application Date
Application Number
152244
Application Product Name
Sabakem Diquat 200 Herbicide
Application details
Product name:
Sabakem Diquat 200 Herbicide
Product number:
97196
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 Diquat dibromide
Soluble Concentrate (SL) formulation.
Reference details:
46534 - REGLONE NON-RESIDUAL HERBICIDE
Active constituents:
Active constituent name
67123 - DIQUAT DIBROMIDE
Active constituent name
62650 - DIQUAT DIBROMIDE
Active constituent name
64501 - DIQUAT DIBROMIDE
Date
Application Date
Application No
Application Number
152452
Product/Active constituent Name
Application Product Name
Macspred Trimac Plus Herbicide
Application Date
Application Number
152452
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 by updating the description for one of the non-active constituent.
Active constituents:
Active constituent name
66681 - CLOPYRALID
Active constituent name
47043 - SULFOMETURON-METHYL
Active constituent name
64443 - TERBACIL
Description of data provided:
Data no
303609
Title
Safety Data Sheet
Study date
24-05-2022
Auth party contact address
13 KENNEDYS DRIVE DELACOMBE Australia
Data no
303610
Title
Safety Data Sheet
Study date
23-12-2022
Auth party contact address
13 KENNEDYS DRIVE DELACOMBE Australia
Date
Application Date
Application No
Application Number
151767
Product/Active constituent Name
Application Product Name
CIMEGRA INSECTICIDE
Application Date
Application Number
151767
Application Product Name
CIMEGRA INSECTICIDE
Application details
Product name:
CIMEGRA INSECTICIDE
Product number:
91936
Applicant Name:
BASF AUSTRALIA LTD.
Application purpose and description of use:
Variation of product registration and label approval to add additional uses
Active constituents:
Active constituent name
86355 - broflanilide
Description of data provided:
Data no
301454
Title
Br0414l BAS 450 Vegetable Brassica 2014-2015
Study date
2015
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
301448
Title
Evaluation of EXP5672774UQI and EXP 5672774AAI for control of cabbage white butterfly (Artogeia rapae) and diamondback moth (Plutella xylostella) in broccoli cv. Aurora
Study date
2013
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
301457
Title
Comparison of BAS 450001 100 SC, BAS 480021 080 OD and BAS 479AAI 100 SC with Coragen 200 SC for the control of diamondback moth (Plutella xylostella) in Chinese cabbage cv. Matilda
Study date
2015
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
301451
Title
BAS450I/LEAFY VEG/DIAMONDBACK MOTH CONTROL
Study date
2024
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
301449
Title
Evaluation of BAS 450 00I for the control of Cabbage White Butterfly in Brassica
Study date
2016
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
301452
Title
BAS450 06 I LETTUCE DIAMONDBACK MOTH CONTROL
Study date
2025
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
301455
Title
Comparison of EXP 5672774UDI 100 SC and EXP 5672774AAI 100 EC with Coragen 200 SC and Belt 480 SC for the control of diamondback moth (Plutella xylostella) in Chinese cabbage cv. Matilda
Study date
2012
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
301447
Title
Part 8 Efficacy Dossier Summary
Study date
2026
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
301462
Title
BAS450I/LEAFY VEG/CROP SAFETY
Study date
2025
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
301456
Title
Comparison of EXP 5672774UQI 100 SC and EXP 5672774AAI 100 EC with Coragen 200 SC, Belt 480 SC and Movento 240 SC for the control of diamondback moth (Plutella xylostella) in Chinese cabbage cv. Matilda
Study date
2013
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
301450
Title
Evaluation of BAS 45006I for control of Cabbage White Butterfly in Brassica
Study date
2024
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
301453
Title
Efficacy and crop safety of BAS 450 06 I against cabbage white butterfly (Pieris rapae) and diamondback moth (Plutella xylostella) in broccoli cv. Ironman.
Study date
2024
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Date
Application Date
Application No
Application Number
152310
Product/Active constituent Name
Application Product Name
Lodisure Flavoured Tablets for Cats
Application Date
Application Number
152310
Application Product Name
Lodisure Flavoured Tablets for Cats
Application details
Product name:
Lodisure Flavoured Tablets for Cats
Product number:
97205
Applicant Name:
DECHRA REGULATORY B.V.
Application purpose and description of use:
Registration of a 1mg amlodipine besylate tablet product for the treatment of feline systemic hypertension.
Active constituents:
Active constituent name
97253 - Amlodipine Besylate
Description of data provided:
Data no
301963
Title
Randomized Placebo-Controlled Clinical Trial of a Chewable Formulation of Amlodipine for the Treatment of Hypertension in Client-Owned Cats
Study date
2015
Auth party contact address
-
Data no
301915
Title
Module 3.3 - Toxicology
Study date
February 2026
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301909
Title
Validation of the assay of amlodipine and amlodipine related substances MV 15.014.001
Study date
21 February 2020
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301946
Title
Lipid nanoparticles for improved topical application of drugs for skin diseases
Study date
2007
Auth party contact address
-
Data no
301955
Title
A study in healthy cats: pharmacokinetics of amlodipine after the oral administration of an amlodipine containing tablet
Study date
2012
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301952
Title
Amlodipine Besylate
Study date
2019
Auth party contact address
-
Data no
301906
Title
Appendix XVI D. Microbiological Quality of Nonsterile Pharmaceutical Preparations and Substances for Pharmaceutical Use
Study date
23 October 2025
Auth party contact address
-
Data no
301969
Title
Effect of Control of Systolic Blood Pressure on Survival in Cats with Systemic Hypertension
Study date
2007
Auth party contact address
-
Data no
301926
Title
Istin 5 mg Tablets Summary of Product Characteristics
Study date
2018
Auth party contact address
-
Data no
301932
Title
Reproductive and Developmental Toxicity Studies with Amlodipine in Rats and Rabbits
Study date
1991
Auth party contact address
-
Data no
301975
Title
Feline Systemic Hypertension: Diagnosis and Management
Study date
2011
Auth party contact address
-
Data no
301943
Title
Product Monograph - Norvasc
Study date
2017
Auth party contact address
-
Data no
301966
Title
Survival of Cats with Naturally Occurring Chronic Renal Failure Is Related to Severity of Proteinuria
Study date
2006
Auth party contact address
-
Data no
301912
Title
Validation of the Total Aerobic Microbial Count, Total Yeast and Moulds Count and absence test of E. coli P347111003-5
Study date
15 November 2011
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301949
Title
Pharmacokinetics of amlodipine besylate at delivery and during lactation
Study date
2018
Auth party contact address
-
Data no
301929
Title
Final Report Amlodipine Besilate Mouse Micronucleus Test
Study date
2019
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301923
Title
Clinical Pharmacokinetics of Amlodipine
Study date
1992
Auth party contact address
-
Data no
301935
Title
Safety Data Sheet - Amlodipine Besylate
Study date
2009
Auth party contact address
-
Data no
301972
Title
Amlodipine: One of the main anti-hypertensive drugs in veterinary therapeutics
Study date
2005
Auth party contact address
-
Data no
301938
Title
Safety Data Sheet - Excipient 2
Study date
2021
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301944
Title
Acute, Subacute and Chronic Toxicity Studies of Amlodipine in Rats
Study date
1991
Auth party contact address
-
Data no
301961
Title
Amlodipine: A Randomized, Blinded Clinical Trial in 9 Cats with Systemic Hypertension
Study date
1998
Auth party contact address
-
Data no
301967
Title
Ocular lesions associated with systemic hypertension in cats: 69 cases (1985 1998)
Study date
2000
Auth party contact address
-
Data no
301898
Title
Certificate of GMP Compliance of a Manufacturer
Study date
05 December 2023
Auth party contact address
-
Data no
301950
Title
Amlodipine Passage into Breast Milk in Lactating Women with Pregnancy-Induced Hypertension and Its Estimation of Infant Risk for Breastfeeding
Study date
2015
Auth party contact address
-
Data no
301930
Title
A review of the genotoxicity of marketed pharmaceuticals
Study date
2001
Auth party contact address
-
Data no
301924
Title
The Metabolism and Pharmacokinetics of Amlodipine in Humans and Animals
Study date
1988
Auth party contact address
-
Data no
301941
Title
Safety Data Sheet - Excipient 5
Study date
2018
Auth party contact address
-
Data no
301918
Title
Module 8.1 - Efficacy and Safety
Study date
February 2026
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301964
Title
Treatment of Systemic Hypertension in Cats with Amlodipine Besylate
Study date
1997
Auth party contact address
-
Data no
301947
Title
Istin 5 mg Tablets Summary of Product Characteristics
Study date
2018
Auth party contact address
-
Data no
301958
Title
Istin 5 mg Tablets Summary of Product Characteristics.
Study date
2018
Auth party contact address
-
Data no
301907
Title
Certificates of Analysis
Study date
29 August 2024
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301921
Title
Non-Compartmental Pharmacokinetics Modeling of Amlodipine in Rats
Study date
2013
Auth party contact address
-
Data no
301970
Title
The prevalence of ocular lesions associated with hypertension in a population of geriatric cats in Auckland, New Zealand
Study date
2013
Auth party contact address
-
Data no
301978
Title
Reproductive and Developmental Toxicity Studies with Amlodipine in Rats and Rabbits
Study date
1991
Auth party contact address
-
Data no
301927
Title
Product Monograph Norvasc
Study date
2017
Auth party contact address
-
Data no
301965
Title
Effect of Amlodipine on Echocardiographic Variables in Cats with Systemic Hypertension
Study date
2001
Auth party contact address
-
Data no
301942
Title
Safety Data Sheet - Excipient 6
Study date
2022
Auth party contact address
-
Data no
301919
Title
Liquid chromatography assay for amlodipine: chemical stability and pharmacokinetics in rabbits
Study date
1991
Auth party contact address
-
Data no
301913
Title
C of A and Product Information LP3533
Study date
19 June 2018
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301959
Title
Product Monograph Norvasc
Study date
2017
Auth party contact address
-
Data no
301953
Title
Treatment of Feline Hypertension With Transdermal Amlodipine: A Pilot Study.
Study date
2007
Auth party contact address
-
Data no
301936
Title
Safety Data Sheet - Lodisure Tablets for Cats
Study date
2026
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301922
Title
The pharmacokinetics of amlodipine in healthy volunteers after single intravenous and oral doses and after 14 repeated oral doses given once daily
Study date
1986
Auth party contact address
-
Data no
301973
Title
Guidelines for the Identification, Evaluation, and Management of Systemic Hypertension in Dogs and Cats
Study date
2007
Auth party contact address
-
Data no
301962
Title
Effects of the calcium channel antagonist amlodipine in cats with surgically induced hypertensive renal insufficiency
Study date
2002
Auth party contact address
-
Data no
301916
Title
Module 3.3 - Work Health and Safety
Study date
February 2026
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301939
Title
Safety Data Sheet - Excipient 3
Study date
2020
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301910
Title
Analytical method transfer report MT15.014
Study date
12 November 2021
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301945
Title
Reproductive and Developmental Toxicity Studies with Amlodipine in Rats and Rabbits
Study date
1991
Auth party contact address
-
Data no
301956
Title
A study in healthy cats: target animal safety and accumulation pharmacokinetics during repeated oral administration of an amlodipine containing tablet
Study date
2011
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301933
Title
Evaluation of the Mutagenic Activity of Amlodipine Besylate in the Salmonella typhimurium Reverse Mutation Assay and the Escherichia coli Reverse Mutation Assay
Study date
2014
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301925
Title
Absorption of Amlodipine Unaffected by Food Solid dose equivalent to solution dose
Study date
1989
Auth party contact address
-
Data no
301976
Title
ISFM Consensus Guidelines on the Diagnosis and Management of Hypertension in Cats
Study date
2017
Auth party contact address
-
Data no
301917
Title
Module 7.4 - Environment
Study date
February 2026
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301940
Title
Safety Data Sheet - Excipient 4
Study date
2014
Auth party contact address
-
Data no
301911
Title
Validation of the dissolution test MV 15.014
Study date
24 June 2019
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301948
Title
Amlodipine Toxicity in Children less than 6 Years of Age: A Dose-Response Analysis using National Poison Data System Data
Study date
2010
Auth party contact address
-
Data no
301957
Title
A study in cats: A combined non-controlled and randomized, double-blind, placebo controlled field trial on orally administered amlodipine 1 mg tablets for treatment of hypertension
Study date
2014
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301977
Title
A Randomised Efficacy Study of a Tablet Containing Amlodipine for Treatment of Cats with Hypertension
Study date
2019
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301908
Title
Assay of amlodipine and amlodipine related substances AM 15.014.001
Study date
21 February 2020
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301971
Title
Survival after diagnosis of hypertension in cats attending primary care practice in the United Kingdom
Study date
2018
Auth party contact address
-
Data no
301934
Title
Final Report Amlodipine Besilate In Vitro Mammalian Chromosome Aberration Test
Study date
2019
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301928
Title
Acute, Subacute and Chronic Toxicity Studies of Amlodipine in Rats
Study date
1991
Auth party contact address
-
Data no
301920
Title
Pharmacokinetics of Amlodipine and Its Occupancy of Calcium Antagonist Receptors
Study date
1994
Auth party contact address
-
Data no
301968
Title
Feline Hypertension: Clinical Findings and Response to Antihypertensive Treatment in 30 Cases
Study date
2001
Auth party contact address
-
Data no
301937
Title
Safety Data Sheet - Excipient 1
Study date
2019
Auth party contact address
-
Data no
301914
Title
C of A and Product Information LP3502
Study date
12 December 2014
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301960
Title
Summary of Product Characteristics - Amlodipine 1.25 mg Ceva chewable tablets for cats
Study date
2018
Auth party contact address
-
Data no
301897
Title
Module 2.1 - Chemistry and Manufacture
Study date
February 2026
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301951
Title
Low Levels of Amlodipine in Breast Milk and Plasma.
Study date
2018
Auth party contact address
-
Data no
301905
Title
Excipient monographs and certificates of analysis
Study date
February 2026
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
301954
Title
Factors Influencing the Relationship Between the Dose of Amlodipine Required for Blood Pressure Control and Change in Blood Pressure in Hypertensive Cats
Study date
2016
Auth party contact address
-
Data no
301931
Title
Evaluation of carcinogenicity studies of medicinal products for human use authorised via the European centralised procedure (1995 2009)
Study date
2011
Auth party contact address
-
Data no
301974
Title
ACVIM consensus statement: Guidelines for the identification, evaluation, and management of systemic hypertension in dogs and cats
Study date
2018
Auth party contact address
-
Date
Application Date
Application No
Application Number
152421
Product/Active constituent Name
Application Product Name
CHLORO-SOL
Application Date
Application Number
152421
Application Product Name
CHLORO-SOL
Application details
Product name:
CHLORO-SOL
Product number:
62983
Applicant Name:
PAH AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to vary relevant particulars.
Description of data provided:
Data no
303524
Title
GMP
Study date
2025
Auth party contact address
20 Buontempo Road CARRUM DOWNS Australia
Data no
302245
Title
Certificate
Study date
2026
Auth party contact address
20 Buontempo Road CARRUM DOWNS Australia
Date
Application Date
Application No
Application Number
152479
Product/Active constituent Name
Application Product Name
Amlodipine Besylate
Application Date
Application Number
152479
Application Product Name
Amlodipine Besylate
Application details
Product name:
Amlodipine Besylate
Active name:
Amlodipine Besylate
Applicant Name:
DECHRA REGULATORY B.V.
Application purpose and description of use:
New source of pharmacopoeia active constituent
Description of data provided:
Data no
303329
Title
Amlodipine besylate drug master file - part 3
Study date
27 February 2026
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
303323
Title
Amlodipine besylate
Study date
05/11/2025
Data no
303330
Title
Amlodipine besylate drug master file - part 4
Study date
27 February 2026
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
303331
Title
Amlodipine besylate Certificates of Analysis
Study date
10 May 2025
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
303328
Title
Amlodipine besylate drug master file - part 2
Study date
27 February 2026
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Data no
303325
Title
Amlodipine besylate drug master file - part 1
Study date
27 February 2026
Auth party contact address
Handelsweg 25 AE Bladel Netherlands
Date
Application Date
Application No
Application Number
152245
Product/Active constituent Name
Application Product Name
SLTEC Fertilizers PHOS-Fight 600 Systemic Fungicide
Application Date
Application Number
152245
Application Product Name
SLTEC Fertilizers PHOS-Fight 600 Systemic Fungicide
Application details
Product name:
SLTEC Fertilizers PHOS-Fight 600 Systemic Fungicide
Product number:
97197
Applicant Name:
SUSTAINABLE LIQUID TECHNOLOGY PTY LTD
Application purpose and description of use:
Registration of a 600 g/L Phosphonic (Phosphorous) Acid present as Mono (and) Di Potassium Phosphite soluble concentrate (SL) product for use as a systemic fungicide for the control of Downy mildew in curcubits, grapes and poppies; Suppression of Phytophthora in Almonds; Phytopthora root & crown rot in ornamentals; Phytophthora Root & Heart Rot in pineapple; Phytophthora Root Rot in avocado, subterranean clover and walnut; Phytophthora Root Rot and Trunk canker in Macadamias; Phytophthora Root Rot & Collar Rot in citrus; Suppression of Phytophthora Trunk and Root Canker in chestnut, as per the directions for use table
Reference details:
65178 - SPRAYPHOS 600 SYSTEMIC FUNGICIDE
Description of data provided:
Data no
303366
Title
PHOS-Fight 600 Document A Feb 2026
Study date
2026
Auth party contact address
2055 FINLAY ROAD TONGALA Australia
Date
Application Date
Application No
Application Number
152413
Product/Active constituent Name
Application Product Name
RELYON CAPTAN 900 WG FUNGICIDE
Application Date
Application Number
152413
Application Product Name
RELYON CAPTAN 900 WG FUNGICIDE
Application details
Product name:
RELYON CAPTAN 900 WG FUNGICIDE
Product number:
97231
Applicant Name:
NUTRIEN AG SOLUTIONS LIMITED
Application purpose and description of use:
Registration of a 900 g/kg WG fungicide for the control of certain diseases in a range of fruit crops, turf & ornamentals.
Reference details:
89490 - RELYON CAPTAN 900 WG FUNGICIDE
67547 - GENFARM CAPTAN 900 WG FUNGICIDE
Active constituents:
Active constituent name
63840 - CAPTAN
Description of data provided:
Data no
303522
Title
Correspondence
Study date
5-Feb-2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
152414
Product/Active constituent Name
Application Product Name
RELYON GLYPHIX 680 DRY HERBICIDE
Application Date
Application Number
152414
Application Product Name
RELYON GLYPHIX 680 DRY HERBICIDE
Application details
Product name:
RELYON GLYPHIX 680 DRY HERBICIDE
Product number:
97232
Applicant Name:
NUTRIEN AG SOLUTIONS LIMITED
Application purpose and description of use:
Registration of a glyphosate 680 g/kg SG herbicide for the control of many annual and perennial weeds in Roundup Ready^ and Roundup Ready Flex^ crops and other situations.
Reference details:
89495 - RELYON GLYPHIX 680 DRY HERBICIDE
65461 - GENFARM PANZER 680 DRY HERBICIDE
Active constituents:
Active constituent name
62532 - GLYPHOSATE
Description of data provided:
Data no
303525
Title
Correspondence
Study date
5-Feb-2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
152653
Product/Active constituent Name
Application Product Name
FLUNAX FLUNIXIN INJECTION
Application Date
Application Number
152653
Application Product Name
FLUNAX FLUNIXIN INJECTION
Application details
Product name:
FLUNAX FLUNIXIN INJECTION
Product number:
93304
Applicant Name:
ASHISH LIFE SCIENCE PVT. LTD.
Application purpose and description of use:
Variation of product registration to vary conditions.
Active constituents:
Active constituent name
93356 - Flunixin meglumine
Description of data provided:
Data no
303466
Title
GMP
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
303467
Title
Closure letter
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
303468
Title
GMP
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India