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
145372
Product/Active constituent Name
Application Product Name
OXYPLUS DRENCH
Application Date
Application Number
145372
Application Product Name
OXYPLUS DRENCH
Application details
Product name:
OXYPLUS DRENCH
Product number:
95366
Applicant Name:
AURA LABORATORIES LIMITED
Application purpose and description of use:
Registration of a (75 g/L Levamisole HCL and 150 g/L Oxiclozanide) Oral Drench product for the control of Levamisole susceptible Round Worms and Liver Fluke in sheep and cattle, also assists in the removal of tapeworm segments in sheep and lambs.
OXYPLUS Drench is a specially formulated mixture of levamisole and oxyclozanide designed for the treatment of sheep and cattle affected with worms and fluke, also assists in the removal of tapeworm segments in sheep and lambs.
Reference details:
91682 - Primus LV Oral Drench
Active constituents:
Active constituent name
95367 - Levamisole Hydrochloride
Active constituent name
95368 - Oxyclozanide
Description of data provided:
Data no
277742
Title
Finished Product Specs
Study date
2024
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Date
Application Date
Application No
Application Number
145373
Product/Active constituent Name
Application Product Name
Levamisole Hydrochloride
Application Date
Application Number
145373
Application Product Name
Levamisole Hydrochloride
Application details
Product name:
Levamisole Hydrochloride
Active name:
Levamisole Hydrochloride
Applicant Name:
AURA LABORATORIES LIMITED
Application purpose and description of use:
New source of active constituent
Description of data provided:
Data no
278152
Title
Active Certificate of analysis
Study date
2024
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Date
Application Date
Application No
Application Number
145374
Product/Active constituent Name
Application Product Name
Oxyclozanide
Application Date
Application Number
145374
Application Product Name
Oxyclozanide
Application details
Product name:
Oxyclozanide
Active name:
Oxyclozanide
Applicant Name:
AURA LABORATORIES LIMITED
Application purpose and description of use:
New source of active constituent
Description of data provided:
Data no
278153
Title
Active Certificates of analysis
Study date
2024
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Date
Application Date
Application No
Application Number
145634
Product/Active constituent Name
Application Product Name
ACCENSI TRIADIMENOL 150 C FLOWABLE SEED DRESSING
Application Date
Application Number
145634
Application Product Name
ACCENSI TRIADIMENOL 150 C FLOWABLE SEED DRESSING
Application details
Product name:
ACCENSI TRIADIMENOL 150 C FLOWABLE SEED DRESSING
Product number:
63620
Applicant Name:
ACCENSI PTY LTD
Application purpose and description of use:
Variation of product label to extend net contents up to 1000L.
Reference details:
63620 - ACCENSI TRIADIMENOL 150 C FLOWABLE SEED DRESSING
Active constituents:
Active constituent name
55456 - CYPERMETHRIN
Active constituent name
49095 - TRIADIMENOL
Description of data provided:
Data no
279842
Title
ACCENSI TRIADIMENOL 150 C FLOWABLE SEED DRESSING
Study date
2024
Auth party contact address
60-76 POTASSIUM STREET NARANGBA Australia
Date
Application Date
Application No
Application Number
145549
Product/Active constituent Name
Application Product Name
Pyroxasulfone
Application Date
Application Number
145549
Application Product Name
Pyroxasulfone
Application details
Product name:
Pyroxasulfone
Active name:
Pyroxasulfone
Applicant Name:
KINGTAI CHEMICALS CO., LIMITED
Application purpose and description of use:
Approval of Pyroxasulfone for use in agricultural chemical products.
Description of data provided:
Data no
279142
Title
Final Amendment 1 to Five Batch Qualitative and Quantitative Profile Study of Pyroxasulfone
98% TC and its Impurities
98% TC and its Impurities
Study date
July 25 2024
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Data no
279143
Title
Part 2 ?C Chemistry
Study date
July 30 2024
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Data no
279144
Title
Five Batch Qualitative and Quantitative Profile Study of Pyroxasulfone 98% TC and its
Impurities
Impurities
Study date
June 14 2024
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Data no
279140
Title
The Manufacturing Process of Pyroxasulfone Technical
Study date
May 23, 2024
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Data no
279141
Title
Declaration of Composition-Kingtai Pyroxasulfone TGAC
Study date
June 29 2024
Auth party contact address
8F, Yuesheng International Center, No. 518 Pinglan Road, QianJiang Century City, China
Date
Application Date
Application No
Application Number
145184
Product/Active constituent Name
Application Product Name
Feliway Optimum Enhanced Serenity Diffuser
Application Date
Application Number
145184
Application Product Name
Feliway Optimum Enhanced Serenity Diffuser
Application details
Product name:
Feliway Optimum Enhanced Serenity Diffuser
Product number:
95282
Applicant Name:
CEVA ANIMAL HEALTH PTY LTD
Application purpose and description of use:
Registration of product FELIWAY OPTIMUM ENHANCED SERENITY DIFFUSER, which contains a unique combination of active ingredients designed to aid in alleviating signs associated with fear, stress, tension, and conflict in kittens and cats. This product helps promote harmonious living within the same household. The active constituents in this product include a complex of fatty acid esters, which are already approved by the APVMA for use in veterinary products.
Active constituents:
Active constituent name
59378 - METHYL MYRISTATE
Active constituent name
59379 - METHYL LAURATE
Active constituent name
59380 - METHYL LINOLEATE
Active constituent name
59381 - METHYL STEARATE
Active constituent name
59166 - METHYL OLEATE
Active constituent name
59167 - METHYL PALMITATE
Active constituent name
59170 - DIMETHYL PIMELATE
Active constituent name
59169 - DIMETHYL AZELATE
Description of data provided:
Data no
276925
Title
Appendix 2-2 - Internal Monograph and Certificate of Analysis
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276926
Title
Appendix 2-3 - Internal Monograph and Certificate of Analysis
Study date
2023
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276927
Title
Appendix 2-4 - Internal Monograph and Certificate of Analysis
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276928
Title
Appendix 2-5 - Internal Monograph and Certificate of Analysis
Study date
2023
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276929
Title
Appendix 2-6 - Internal Monograph and Certificate of Analysis
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276930
Title
Appendix 2-7 - Internal Monograph and Certificate of Analysis
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276931
Title
Appendix 2-8 - Internal Monograph and Certificate of Analysis
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276932
Title
Appendix 2-9 - Internal Monograph and Certificate of Analysis
Study date
2021
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276937
Title
Analytical Method for Active constituents in Finished product
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276938
Title
Validation of Analytical Method for Active constituents in Finished product
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276939
Title
Technical Specifications of Diffuser
Study date
2021
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276940
Title
Packaging Specifications
Study date
2015
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276933
Title
Internal Monograph and Certificate of Analysis for Solvent
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276935
Title
Manufacturing Process Validation Report
Study date
2023
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276924
Title
Pre-application Assistance - APVMA Written Assistance and Application
Study date
2022
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276934
Title
GMP Certificates
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276974
Title
Part 2 - Feliway Optimum
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276936
Title
Stability Report
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276975
Title
Part 8 - Feliway Optimum
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276976
Title
Case challenge series - Feline House soiling
Study date
2001
Auth party contact address
-
Data no
276977
Title
Usefulness of the F3 synthetic pheromone FELIWAY in preventing behaviour problems in cats during holidays
Study date
1997
Auth party contact address
-
Data no
276978
Title
Effect of a Feline appeasing pheromone analogue on manifestations of stress in cats during transport.
Study date
1998
Auth party contact address
-
Data no
276979
Title
Cytokines and FIC: therapeutic implications
Study date
2000
Auth party contact address
-
Data no
276980
Title
Effects of a synthetic facial pheromone on behaviour and food intake of caged cats
Study date
1999
Auth party contact address
-
Data no
276981
Title
Effects of a synthetic facial pheromone on behaviour in cats.
Study date
2000
Auth party contact address
-
Data no
276982
Title
Managing common lower urinary tract disorders of cats
Study date
2001
Auth party contact address
-
Data no
276983
Title
The F3 Fraction of feline facial pheromones calms cats prior to intravenous catheterization
Study date
2000
Auth party contact address
-
Data no
276984
Title
Common Feline Problem Behaviors Destructive Scratching
Study date
2019
Auth party contact address
-
Data no
276985
Title
Effect of a synthetic analogue of the feline facial pheromone on salivary cortisol levels in the domestic cat
Study date
2017
Auth party contact address
-
Data no
276986
Title
2015 AAHA Canine and Feline Behavior Management Guidelines
Study date
2015
Auth party contact address
-
Data no
276941
Title
Aggression in Cats
Study date
2009
Auth party contact address
-
Data no
276942
Title
Intercat aggression in households following the introduction of a new cat
Study date
2005
Auth party contact address
-
Data no
276943
Title
Behavioural Reasons for Relinquishment of Dogs and Cats to 12 Shelters
Study date
2000
Auth party contact address
-
Data no
276944
Title
Intercat Conflict
Study date
2016
Auth party contact address
-
Data no
276945
Title
Current research in canine and feline pheromones. The Veterinary Clinics.
Study date
2003
Auth party contact address
-
Data no
276956
Title
Ultrasensitive pheromone detection by mammalian vomeronasal neurons.
Study date
2000
Auth party contact address
-
Data no
276957
Title
Chemocommunication among Domestic Cats, Mediated by the Olfactory and Vomeronasal Senses
Study date
1976
Auth party contact address
-
Data no
276958
Title
Chemical communication in the realm of pet carnivores
Study date
1997
Auth party contact address
-
Data no
276959
Title
Structure and Function of the vomeronasal organ
Study date
1998
Auth party contact address
-
Data no
276960
Title
Evaluation of the efficacy of an appeasing pheromone diffuser vs placebo for management of feline aggression in multi-cat households: a pilot study.
Study date
2018
Auth party contact address
-
Data no
276961
Title
Marketing study to evaluate the owner satisfaction when shifting from Feliway Diffuser or Feliway Friends to Feliway Optimum
Study date
2020
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276962
Title
Consumer test to evaluate the added value to Feliway Optimum in the management of cats with behavior issues
Study date
2021
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276963
Title
An Initial Open-Label Study of a Novel Pheromone Complex for Use in Cats
Study date
2021
Auth party contact address
-
Data no
276964
Title
Evaluation of a novel method for delivering a synthetic analogue of feline facial pheromone to control urine spraying by cats
Study date
2001
Auth party contact address
-
Data no
276965
Title
Pheromonatherapy - An integral part of modern companion animal practice
Study date
2002
Auth party contact address
-
Data no
276966
Title
Functions and use of the facial pheromones in the treatment of urine marking in the cat. Interest of a structural analogue
Study date
1996
Auth party contact address
-
Data no
276967
Title
Efficacy of a synthetic feline facial pheromone (F3) analogue (Feliway) for the treatment of chronic non-sexual urine spraying by the domestic cat
Study date
1997
Auth party contact address
-
Data no
276968
Title
Evaluation of the Use of a Pheromone Analogue (Feliway) to Control Urine Marking in Cats
Study date
1998
Auth party contact address
-
Data no
276969
Title
Clinical trial of a feline pheromone analogue for feline urine marking
Study date
2001
Auth party contact address
-
Data no
276970
Title
Treatments for Spraying cats
Study date
1998
Auth party contact address
-
Data no
276971
Title
Urine spraying in cats: presence of concurrent disease and effects of a pheromone treatment
Study date
1999
Auth party contact address
-
Data no
276972
Title
Evaluating a feline facial pheromone analogue to control urine spraying
Study date
2000
Auth party contact address
-
Data no
276973
Title
Long term follow up of the effect of a pheromone therapy on feline spraying behaviour
Study date
2000
Auth party contact address
-
Data no
276946
Title
Pre-Application Assistance - APVMA Written Assistance. PAA-ID: DCPAA2-55631697A
Study date
2022
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276947
Title
Scientifical Expert Statement-meta analysis feasibility
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276948
Title
Ceva Pharmacovigilance Periodic Safety Update Report, Feliway Diffuser, April 2021
Study date
2021
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276949
Title
Excel file - Line report to accompany Ceva Pharmacovigilance Periodic Safety Update Report, Feliway Diffuser, April 2021.
Study date
2021
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276950
Title
Ceva Pharmacovigilance Periodic Safety Update Report, Feliway Friends Diffuser, April 2021
Study date
2021
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276951
Title
Excel file - Line report to accompany Ceva Pharmacovigilance Periodic Safety Update Report, Feliway Friends Diffuser
Study date
2021
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276952
Title
Ceva Pharmacovigilance Periodic Safety Update Report, Feliway Optimum, July 2021
Study date
2021
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276953
Title
Excel file - Line report to accompany Ceva Pharmacovigilance Periodic Safety Update Report 2021, Feliway Optimum
Study date
2021
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276954
Title
Ceva Pharmacovigilance Periodic Safety Update Report, Feliway Optimum, January 2024
Study date
2023
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276955
Title
Excel file - Line report to accompany Ceva Pharmacovigilance Periodic Safety Update Report 2023, Feliway Optimum
Study date
2023
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276987
Title
Ceva SDS for Feliway Optimum Diffuser
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276989
Title
Technical data sheet for electrical diffuser
Study date
2021
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276991
Title
User Safety: Expert report and documentation
Study date
2001
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276990
Title
Trial Report: Assessment of the Tolerance of DAP Electric Diffuser and Feliway Electric Diffuser in Broiler Chickens, 2003
Study date
2003
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276988
Title
Declaration of Product Code Equivalence - Feliway Optimum
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Date
Application Date
Application No
Application Number
145590
Product/Active constituent Name
Application Product Name
Farmalinx Swysh 400 EC Herbicide
Application Date
Application Number
145590
Application Product Name
Farmalinx Swysh 400 EC Herbicide
Application details
Product name:
Farmalinx Swysh 400 EC Herbicide
Product number:
89664
Applicant Name:
FARMALINX PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to increase the range of packs to include a 1000 L.
Active constituents:
Active constituent name
59455 - FLUROXYPYR-MEPTYL
Date
Application Date
Application No
Application Number
145659
Product/Active constituent Name
Application Product Name
GENFARM GLUFOSINATE 200 HERBICIDE
Application Date
Application Number
145659
Application Product Name
GENFARM GLUFOSINATE 200 HERBICIDE
Application details
Product name:
GENFARM GLUFOSINATE 200 HERBICIDE
Product number:
66314
Applicant Name:
NUTRIEN AG SOLUTIONS LIMITED
Application purpose and description of use:
Variation to add an alternative formulation.
Reference details:
94391 - Liben Glufosinate 200 Herbicide
Active constituents:
Active constituent name
64470 - GLUFOSINATE-AMMONIUM
Active constituent name
64779 - GLUFOSINATE-AMMONIUM
Description of data provided:
Data no
279732
Title
Supporting documentation
Study date
26-Sep-2024
Date
Application Date
Application No
Application Number
145679
Product/Active constituent Name
Application Product Name
Doramectin
Application Date
Application Number
145679
Application Product Name
Doramectin
Application details
Product name:
Doramectin
Active name:
Doramectin
Applicant Name:
NUTRIEN AG SOLUTIONS LIMITED
Application purpose and description of use:
Approval of Doramectin TGAC for use in veterinary chemical products.
Description of data provided:
Data no
278676
Title
Certificate of Analysis x5
Study date
16/05/2023
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
278677
Title
Specifications
Study date
2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
145360
Product/Active constituent Name
Application Product Name
Sabakem Clopyralid 600SL
Application Date
Application Number
145360
Application Product Name
Sabakem Clopyralid 600SL
Application details
Product name:
Sabakem Clopyralid 600SL
Product number:
95363
Applicant Name:
SABAKEM PTY LTD
Application purpose and description of use:
Registration of a 600g/L of Clopyralid Soluble Concentrate (SL) for the control of a wide range of broadleaf weeds in wheat, barley, triticale, oats, pastures, canola, fallow land, forests and industrial situations as specified in the Directions for Use.
Reference details:
90812 - eChem Clopyralid 600 Herbicide
Active constituents:
Active constituent name
67719 - CLOPYRALID
Active constituent name
66681 - CLOPYRALID
Date
Application Date
Application No
Application Number
145585
Product/Active constituent Name
Application Product Name
Pyroxasulfone
Application Date
Application Number
145585
Application Product Name
Pyroxasulfone
Application details
Product name:
Pyroxasulfone
Active name:
Pyroxasulfone
Applicant Name:
AGRO CROWN AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of Pyroxasulfone for use in agricultural chemical products.
Description of data provided:
Data no
279802
Title
Five Batch Analysis of Pyroxasulfone Technical
Study date
2024 July
Auth party contact address
3 DALE STREET DEEPDENE DEEPDENE Australia
Data no
279803
Title
Manufacture of process -Pyroxasulfone TC
Study date
2024
Auth party contact address
3 DALE STREET DEEPDENE DEEPDENE Australia
Data no
279804
Title
Specification of Pyroxasulfone Tech
Study date
2024
Auth party contact address
3 DALE STREET DEEPDENE DEEPDENE Australia
Date
Application Date
Application No
Application Number
145362
Product/Active constituent Name
Application Product Name
Sabakem Abamectin 18EC
Application Date
Application Number
145362
Application Product Name
Sabakem Abamectin 18EC
Application details
Product name:
Sabakem Abamectin 18EC
Product number:
95365
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 18g/L Abamectin
Emulsifiable concentrate (EC) formulation.
Reference details:
53306 - ECHEM ABAMECTIN INSECTICIDE/MITICIDE
Active constituents:
Active constituent name
44497 - ABAMECTIN
Date
Application Date
Application No
Application Number
145661
Product/Active constituent Name
Application Product Name
KELPIE TRI-F 480 HERBICIDE
Application Date
Application Number
145661
Application Product Name
KELPIE TRI-F 480 HERBICIDE
Application details
Product name:
KELPIE TRI-F 480 HERBICIDE
Product number:
88891
Applicant Name:
SINOCHEM INTERNATIONAL AUSTRALIA PTY. LTD.
Application purpose and description of use:
Variation of product registration to add an alternative formulation.
Reference details:
81536 - ACCENSI TRI-MAX 480 EC HERBICIDE
Active constituents:
Active constituent name
59597 - TRIFLURALIN
Description of data provided:
Data no
279734
Title
Letter of Access
Study date
25.9.24
Date
Application Date
Application No
Application Number
145718
Product/Active constituent Name
Application Product Name
VETSENSE Abamec LV Pour-On for Cattle
Application Date
Application Number
145718
Application Product Name
VETSENSE Abamec LV Pour-On for Cattle
Application details
Product name:
VETSENSE Abamec LV Pour-On for Cattle
Product number:
95453
Applicant Name:
VETSENSE PTY LTD
Application purpose and description of use:
Registration of a pour-on solution of 10g/L of abamectin for the treatment and control of abamectin sensitive internal and external parasites of beef and dairy cattle
Reference details:
61790 - WSD ENDOMEC ABAMECTIN POUR ON FOR DAIRY AND BEEF CATTLE
Active constituents:
Active constituent name
82526 - ABAMECTIN
Description of data provided:
Data no
279038
Title
API - CoA
Study date
2024
Auth party contact address
1/36 CURTIS ROAD MULGRAVE Australia
Data no
279040
Title
CoAs
Study date
2024
Auth party contact address
1/36 CURTIS ROAD MULGRAVE Australia
Data no
279039
Title
Finish Product specifications
Study date
2024
Auth party contact address
1/36 CURTIS ROAD MULGRAVE Australia
Date
Application Date
Application No
Application Number
145551
Product/Active constituent Name
Application Product Name
SABAKEM PRAZON 400EC SELECTIVE HERBICIDE
Application Date
Application Number
145551
Application Product Name
SABAKEM PRAZON 400EC SELECTIVE HERBICIDE
Application details
Product name:
SABAKEM PRAZON 400EC SELECTIVE HERBICIDE
Product number:
69889
Applicant Name:
SABAKEM PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to add a new pack size (1000L)
Reference details:
68743 - AC SCRUBBA HERBICIDE
Active constituents:
Active constituent name
53881 - PICLORAM
Active constituent name
67316 - TRICLOPYR BUTOXYETHYL ESTER
Description of data provided:
Data no
279248
Title
Executive Summary
Study date
Sep 2024
Auth party contact address
Suite 809, Level 8, 2 Queen Street Melbourne Australia
Date
Application Date
Application No
Application Number
145566
Product/Active constituent Name
Application Product Name
Nufarm Dropzone Herbicide
Application Date
Application Number
145566
Application Product Name
Nufarm Dropzone Herbicide
Application details
Product name:
Nufarm Dropzone Herbicide
Product number:
91596
Applicant Name:
NUFARM AUSTRALIA LIMITED
Application purpose and description of use:
Variation of product registration and label approval to extend the Directions for Use to include use in cereals.
Active constituents:
Active constituent name
44393 - 2,4-D
Description of data provided:
Data no
279382
Title
Nufarm Dropzone Herbicide draft label
Study date
September 2024
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
279376
Title
DC14-44601371 ITEM 14, EFFICACY and SAFETY 3 91596 NUFARM DROPZONE HERBICIDE
Study date
August 2024
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
279377
Title
CROP SAFETY OF DROPZONE IN WHEAT AND BARLEY
Study date
2024
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
279378
Title
Crop safety of DROPZONE in Wheat and Barley, Horsham, Victoria, 2023
Study date
March 2024
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
279379
Title
Crop safety of DROPZONE in Wheat and Barley, York, Western Australia 2023
Study date
February 2024
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
279380
Title
Evaluation of DROPZONE 500 for safety in barley cv. Planet, West Pine, Tasmania, 2023-24
Study date
May 2024
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
279381
Title
Evaluation of DROPZONE 500 for safety in wheat cv. Calabro, Sassafras, Tasmania, 2023-24 Appendix 8.6
Study date
May 2024
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
279374
Title
DC14-44601371 NUFARM DROPZONE HERBICIDE ITEM 14 APPLICATION EXECUTIVE SUMMARY
Study date
September 2024
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Data no
279375
Title
Nufarm Dropzone Herbicide draft label
Study date
September 2024
Auth party contact address
103-105 PIPE RD LAVERTON NORTH Australia
Date
Application Date
Application No
Application Number
143072
Product/Active constituent Name
Application Product Name
Tasipimidine sulfate
Application Date
Application Number
143072
Application Product Name
Tasipimidine sulfate
Application details
Product name:
Tasipimidine sulfate
Product number:
94642
Applicant Name:
MAVLAB ANIMAL HEALTH PTY LTD
Application purpose and description of use:
Registration of a 0.3 mg/mL tasipimidine sulfate oral solution product for the short term alleviation of situational anxiety and fear in dogs triggered by noise or owner departure, in conjunction with approval of tasipimidine sulfate.
Description of data provided:
Data no
268527
Title
3.2.S.4.2 Analytical procedures
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268528
Title
3.2.S.4.3 Validation of analytical procedures
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268529
Title
3.2.S.4.3_1 Validation report 1
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268530
Title
3.2.S.4.3_2 Validation report 2
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268531
Title
3.2.S.4.3_3 Validation report 3
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268494
Title
Certificates of analysis for active constituent
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268522
Title
3.2.S.4.4 Batch analyses
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268521
Title
3.2.S.4.1 Specification
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268500
Title
3.2.S.2.1 Manufacturer(s)
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268501
Title
3.2.S.2.1_1 GMP certificate 1
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268502
Title
3.2.S.2.1_2 GMP certificate 2
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268503
Title
3.2.S.2.1_3 GMP certificate 3
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268504
Title
3.2.S.2.1_4 GMP certificate 4
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268505
Title
3.2.S.2.2 Description of manufacturing process and controls
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268506
Title
3.2.S.2.4 Control of critical steps and intermediates
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268507
Title
3.2.S.2.5 Process validation and/or evaluation
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268508
Title
3.2.S.3.1 Elucidation of Structure
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268509
Title
3.2.S.3.2 Impurities
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268510
Title
3.2.S.3.1-1 CoA
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268511
Title
3.2.S.3.1-2 NMR spectra
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268512
Title
3.2.S.3.1-3 Mass spectrum
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268513
Title
3.2.S.3.1-4 IR spectra
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268514
Title
3.2.S.3.1-5 XRPD spectra
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268515
Title
3.2.S.6 Container closure system
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268516
Title
3.2.S.6_1 Declaration of compliance for primary packaging (1)
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268517
Title
3.2.S.6_2 Declaration of compliance for primary packaging (2)
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268532
Title
2.3.S Drug Substance QOS
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268533
Title
API DMF
Study date
2024
Data no
268523
Title
3.2.S.5 Reference standard or material
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268524
Title
CoA reference standard 1
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268526
Title
CoA reference standard 2
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268495
Title
ASMF - D180 LoOI Responses
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268496
Title
DMF 2.3.S
Study date
2021
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268497
Title
3.2.S.1.1 Nomenclature
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268498
Title
3.2.S.1.3 General Properties
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268499
Title
3.2.S.1.2 Structure
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268518
Title
3.2.S.7.1 Stability Summary & Conclusions
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268519
Title
3.2.S.7.2 Post-approval stability protocol committment
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Data no
268520
Title
3.2.S.7.3 Stability data
Study date
2024
Auth party contact address
29-33 ROWLAND STREET SLACKS CREEK Australia
Date
Application Date
Application No
Application Number
145529
Product/Active constituent Name
Application Product Name
Farmers’ Own Abamectin and Levamisole Pour-On for Cattle
Application Date
Application Number
145529
Application Product Name
Farmers’ Own Abamectin and Levamisole Pour-On for Cattle
Application details
Product name:
Farmers’ Own Abamectin and Levamisole Pour-On for Cattle
Product number:
95407
Applicant Name:
ARROVET PTY LTD
Application purpose and description of use:
Registration of a 10 mg/mL abamectin and 200 mg/mL levamisole pour-on solution product for the treatment and control of roundworms and external parasites in cattle.
Reference details:
60752 - ECLIPSE COMBINATION POUR-ON FOR CATTLE
Active constituents:
Active constituent name
82843 - ABAMECTIN
Active constituent name
82834 - LEVAMISOLE BASE
Description of data provided:
Data no
278427
Title
Product specifications
Study date
2024
Auth party contact address
MQX 4, Level 6 Giffnock Ave Macquarie Park Australia
Date
Application Date
Application No
Application Number
145695
Product/Active constituent Name
Application Product Name
Farmers’ Own Thiacloprid Dip for Sheep
Application Date
Application Number
145695
Application Product Name
Farmers’ Own Thiacloprid Dip for Sheep
Application details
Product name:
Farmers’ Own Thiacloprid Dip for Sheep
Product number:
95440
Applicant Name:
ARROVET PTY LTD
Application purpose and description of use:
Registration of a 480 g/L thiacloprid dip for the control of neonicotinoid susceptible and IGR resistant strains of body lice Bovicola ovis on short wool sheep.
Reference details:
63766 - PIRANHA DIP FOR SHEEP
Active constituents:
Active constituent name
90021 - thiacloprid
Description of data provided:
Data no
278742
Title
Product specifications
Study date
2024
Auth party contact address
MQX 4, Level 6 Giffnock Ave Macquarie Park Australia
Date
Application Date
Application No
Application Number
145576
Product/Active constituent Name
Application Product Name
Tribeca Fungicide
Application Date
Application Number
145576
Application Product Name
Tribeca Fungicide
Application details
Product name:
Tribeca Fungicide
Product number:
89902
Applicant Name:
TURF CULTURE PTY LTD
Application purpose and description of use:
Variation of product registration to add a new disease.
Active constituents:
Active constituent name
88784 - Fludioxonil
Active constituent name
69141 - TRITICONAZOLE
Description of data provided:
Data no
279426
Title
Evaluate various products for the control of Grey Leaf Spot (Pyricularia grisea) in turf.
Study date
24 August 2024
Auth party contact address
43 Gap Road Sunbury Australia
Data no
279427
Title
Evaluate various products for the control of Grey Leaf Spot (Pyricularia grisea) in turf.
Study date
27 August 2024
Auth party contact address
43 Gap Road Sunbury Australia
Data no
279428
Title
Evaluation of fungicides for disease control on warm season turf.
Study date
23 April 2019
Auth party contact address
43 Gap Road Sunbury Australia
Data no
279429
Title
Part 8 - E&S - Tribeca Fungicide
Study date
September 2024
Auth party contact address
43 Gap Road Sunbury Australia