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
145515
Product/Active constituent Name
Application Product Name
MINERAX WITH B12 INJECTION FOR CATTLE
Application Date
Application Number
145515
Application Product Name
MINERAX WITH B12 INJECTION FOR CATTLE
Application details
Product name:
MINERAX WITH B12 INJECTION FOR CATTLE
Product number:
95398
Applicant Name:
AURA LABORATORIES LIMITED
Application purpose and description of use:
Registration of a 1.4 g/L Cyanocobalamin, 3.3 g/L Selenium (as Sodium selenite), 6.7 g/L Manganese (as Manganese edetate), 26.7 g/L Zinc (as Zinc edetate), 10 g/L Copper (as Copper edetate) parenteral liquid/solution product is a chelated trace element injection for beef and dairy cattle deficient in and/or responsive to copper, manganese, zinc, selenium and/or vitamin B12 supplementation.
MINERAX WITH B12 INJECTION FOR CATTLE contains selenium, copper, zinc, manganese and vitamin B12, which are required for optimal health, production and fertility. Sub-optimal trace mineral and vitamin B12 status at calving, mating and drying off has been shown to negatively impact production, reproduction and health.
Reference details:
87283 - MARKS-MIN INJECTABLE TRACE MINERAL WITH VITAMIN B12 FOR CATTLE
Description of data provided:
Data no
282513
Title
Appendix 4 - Zinc Disodium EDTA COAs - updated
Study date
2024
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Data no
294309
Title
Scientific Justificaiton for Efficacy, Safety and Trade criteria
Study date
2025
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Data no
282510
Title
Appendix 1 - Cyanocobalamin COAs - updated
Study date
2022
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Data no
282511
Title
Appendix 2 - Cyanocobalamin COAs - updated
Study date
2024
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Data no
278415
Title
Finished Product Specs
Study date
2024
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Data no
282512
Title
Appendix 3 - Copper Disodium EDTA COAs - updated
Study date
2024
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Date
Application Date
Application No
Application Number
145680
Product/Active constituent Name
Application Product Name
VGrade Metoclopramide Injection
Application Date
Application Number
145680
Application Product Name
VGrade Metoclopramide Injection
Application details
Product name:
VGrade Metoclopramide Injection
Product number:
95435
Applicant Name:
INVETRO PTY LTD
Application purpose and description of use:
Registration of a 5 mg/mL metoclopramide hydrochloride solution for injection as an anti-emetic for dogs and cats.
Reference details:
36700 - METOMIDE ANTI-EMETIC STERILE INJECTION
Active constituents:
Active constituent name
95436 - Metoclopramide Hydrochloride
Description of data provided:
Data no
282828
Title
?Metoclopramide for dogs, cats, and horses?,
Study date
2022
Auth party contact address
-
Data no
282805
Title
GMP Inspection Report
Study date
2022
Data no
278683
Title
TGA Clearance
Study date
2023
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
282822
Title
?Gastrointestinal Prokinetic Drugs Used in Monogastric Animals?
Study date
2023
Auth party contact address
-
Data no
282811
Title
?Metoclopramide reversal of decreased gastrointestinal myoelectric and contractile activity in a model of canine postoperative ileus.?
Study date
1989
Auth party contact address
-
Data no
282825
Title
?Efficacy of Different Antiemetics with Different Mechanism of Action on Xylazine Induced Emesis in Cats?
Study date
2014
Auth party contact address
-
Data no
282831
Title
Metomide SDS
Study date
2013
Auth party contact address
-
Data no
282808
Title
?Effects of metoclopramide on emesis in cats sedated with xylazine hydrochloride.? vol. 12,12 (2010): 899-903.
Study date
2010
Auth party contact address
-
Data no
278686
Title
Finished Product Test Methods Validations a
Study date
2019
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
282819
Title
?Metoclopramide 5mg/mL Safety Data Sheet?
Study date
2014
Auth party contact address
-
Data no
278689
Title
Manufacturing Process, Flow Chart & Quality Control Details
Study date
2024
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
282826
Title
?Effect of metoclopramide on nausea and emesis in dogs premedicated with morphine and dexmedetomidine.?
Study date
2018
Auth party contact address
-
Data no
278692
Title
Application Overview
Study date
2024
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
282820
Title
Metoclopramide
Study date
2025
Auth party contact address
-
Data no
278684
Title
Finished Product Certificates of Analysis
Study date
2023
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
282817
Title
?Metoclopramide Hydrochloride 5 mg/mL solution for injection Public Assment Report PL 24598/0087, Noriderm Enterprises Limited?
Study date
2022
Auth party contact address
-
Data no
282823
Title
, ?Metoclopramide? , (2011) 28: 187-188.
Study date
2011
Auth party contact address
-
Data no
282814
Title
?Diagnostic strategy for vomiting in dogs and cats (Proceedings)? , Available at:https://www.dvm360.com/view/diagnostic-strategy-vomiting-dogs-and-cats-proceedings-0 (2011) Accessed: 21 January 2025).
Study date
2011
Auth party contact address
-
Data no
282809
Title
?A comparison between maropitant and metoclopramide for the prevention of morphine-induced nausea and vomiting in dogs.?
Study date
2017
Auth party contact address
-
Data no
282818
Title
Metoclopramide Baxter Data Sheet (NZ)
Study date
2019
Auth party contact address
-
Data no
278687
Title
Finished Product Test Methods Validations b
Study date
2019
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
278690
Title
Manufacturing Process Validation
Study date
2019
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
282815
Title
?Metoclopramide HCl (Reglan?) for Dogs and Cats?
Study date
2015
Auth party contact address
-
Data no
282806
Title
?Comparative efficacy of metoclopramide, ondansetron and maropitant in preventing parvoviral enteritis-induced emesis in dogs.?
Study date
2017
Auth party contact address
-
Data no
282829
Title
?Vomend 5 mg/ml solution for injection for cats and dogs?
Study date
2015
Auth party contact address
-
Data no
282821
Title
Acute vomiting in cats: rational treatment selection.
Study date
2010
Auth party contact address
-
Data no
278693
Title
CMC Overview
Study date
2024
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
282812
Title
?Exploring The Uses Of Metoclopramide For Dogs?
Study date
2024
Auth party contact address
-
Data no
282830
Title
?Influence of metoclopramide on gastroesophageal reflux in anesthetized dogs.?
Study date
2006
Auth party contact address
-
Data no
282807
Title
?Ultrasonographic assessment of the effect of metoclopramide, erythromycin, and exenatide on solid-phase gastric emptying in healthy cats.?
Study date
2020
Auth party contact address
-
Data no
278694
Title
Finished Product Specification and Test Methods
Study date
2024
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
282824
Title
?Efficacy of metoclopramide for treatment of ileus in horses following small intestinal surgery: 70 cases (1989-1992).?
Study date
1996
Auth party contact address
-
Data no
278685
Title
Excipient Certificate of Analysis
Study date
2023
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
282813
Title
?The Effect of Maropitant, Ondansetron and Metoclopramide on Dexmedetomidine-Induced Vomiting in Cats.?
Study date
2025
Auth party contact address
-
Data no
282827
Title
?Metoclopramide?
Study date
2023
Auth party contact address
-
Data no
282810
Title
?Antiemetic therapy in dogs and cats: new versus old (Proceedings)?
Study date
2009
Auth party contact address
-
Data no
278682
Title
GMP Certificate
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
278691
Title
Packaging Specifications
Study date
2024
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
278688
Title
Stability Studies
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
282816
Title
?Metoclopramide Hydrochloride 5 mg/mL solution for injection Public Assment Report PL 20568/0076, Claris Lifesciences UK Limited?
Study date
2017
Auth party contact address
-
Date
Application Date
Application No
Application Number
145569
Product/Active constituent Name
Application Product Name
MILBEMAX TABLETS FOR DOGS
Application Date
Application Number
145569
Application Product Name
MILBEMAX TABLETS FOR DOGS
Application details
Product name:
MILBEMAX TABLETS FOR DOGS
Product number:
54266
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of product label approval to increase dose frequency, enhance clarity and incorporate sustainability initiatives in disposal section.
Active constituents:
Active constituent name
55481 - EXELPET SPOT-ON FLEA CONTROL FOR CATS AND KITTENS
Active constituent name
84391 - PRAZIQUANTEL
Date
Application Date
Application No
Application Number
145570
Product/Active constituent Name
Application Product Name
MILBEMAX TABLETS FOR SMALL DOGS AND PUPPIES
Application Date
Application Number
145570
Application Product Name
MILBEMAX TABLETS FOR SMALL DOGS AND PUPPIES
Application details
Product name:
MILBEMAX TABLETS FOR SMALL DOGS AND PUPPIES
Product number:
59225
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of product label approval to increase dose frequency, enhance clarity and incorporate sustainability initiatives in disposal section.
Active constituents:
Active constituent name
84391 - PRAZIQUANTEL
Description of data provided:
Data no
282949
Title
Part 8 Efficacy Safety Milbemax Final
Study date
23 Dec 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
282950
Title
s159 response
Study date
2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
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
296845
Title
Development of a Cat Bebahiour Issues Assessment Scale
Study date
2023
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
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
276934
Title
GMP Certificates
Study date
2024
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
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
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
276983
Title
The F3 Fraction of feline facial pheromones calms cats prior to intravenous catheterization
Study date
2000
Auth party contact address
-
Data no
276940
Title
Packaging Specifications
Study date
2015
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
276991
Title
User Safety: Expert report and documentation
Study date
2001
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
286243
Title
CoA Dimethyl pimelate
Study date
25/04/2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
296848
Title
Adverse Event Report
Study date
2025
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
276974
Title
Part 2 - Feliway Optimum
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276957
Title
Chemocommunication among Domestic Cats, Mediated by the Olfactory and Vomeronasal Senses
Study date
1976
Auth party contact address
-
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
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
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
276937
Title
Analytical Method for Active constituents in Finished product
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276969
Title
Clinical trial of a feline pheromone analogue for feline urine marking
Study date
2001
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
296843
Title
Pheromones and Mammalian Behaviour
Study date
2010
Auth party contact address
-
Data no
276975
Title
Part 8 - Feliway Optimum
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276958
Title
Chemical communication in the realm of pet carnivores
Study date
1997
Auth party contact address
-
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
296849
Title
Ceva response
Study date
2025
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
276989
Title
Technical data sheet for electrical diffuser
Study date
2021
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
296846
Title
Chemical and behavioural characterization of rabbit pheromone
Study date
2003
Auth party contact address
-
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
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
276972
Title
Evaluating a feline facial pheromone analogue to control urine spraying
Study date
2000
Auth party contact address
-
Data no
276935
Title
Manufacturing Process Validation Report
Study date
2023
Auth party contact address
11 MOORES RD GLENORIE Australia
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
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
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
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
276986
Title
2015 AAHA Canine and Feline Behavior Management Guidelines
Study date
2015
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
296847
Title
Pheromones and Animal Behaviour
Study date
2014
Auth party contact address
-
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
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
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
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
276981
Title
Effects of a synthetic facial pheromone on behaviour in cats.
Study date
2000
Auth party contact address
-
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
276987
Title
Ceva SDS for Feliway Optimum Diffuser
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
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
276944
Title
Intercat Conflict
Study date
2016
Auth party contact address
-
Data no
276970
Title
Treatments for Spraying cats
Study date
1998
Auth party contact address
-
Data no
276947
Title
Scientifical Expert Statement-meta analysis feasibility
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
296844
Title
Efficacy of a pheromone-impregnated collar
Study date
2024
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
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
276984
Title
Common Feline Problem Behaviors Destructive Scratching
Study date
2019
Auth party contact address
-
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
276941
Title
Aggression in Cats
Study date
2009
Auth party contact address
-
Data no
286242
Title
Letter of response
Study date
12/05/2025
Auth party contact address
11 MOORES RD GLENORIE Australia
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
276965
Title
Pheromonatherapy - An integral part of modern companion animal practice
Study date
2002
Auth party contact address
-
Data no
276936
Title
Stability Report
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276956
Title
Ultrasensitive pheromone detection by mammalian vomeronasal neurons.
Study date
2000
Auth party contact address
-
Data no
276979
Title
Cytokines and FIC: therapeutic implications
Study date
2000
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
276942
Title
Intercat aggression in households following the introduction of a new cat
Study date
2005
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
276976
Title
Case challenge series - Feline House soiling
Study date
2001
Auth party contact address
-
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
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
276933
Title
Internal Monograph and Certificate of Analysis for Solvent
Study date
2024
Auth party contact address
11 MOORES RD GLENORIE Australia
Data no
276982
Title
Managing common lower urinary tract disorders of cats
Study date
2001
Auth party contact address
-
Data no
276959
Title
Structure and Function of the vomeronasal organ
Study date
1998
Auth party contact address
-
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
276939
Title
Technical Specifications of Diffuser
Study date
2021
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
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
290725
Title
DMF 32s31
Study date
2024
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
Data no
290731
Title
DMF 32s434
Study date
2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
290734
Title
Explanation letter
Study date
2025
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
290728
Title
DMF 32s431
Study date
2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
290723
Title
DMF 32s25
Study date
2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
290729
Title
DMF 32s432
Study date
2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
290720
Title
DMF 32s22
Study date
2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
290726
Title
DMF 32s32
Study date
2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
290732
Title
DMF 32s45
Study date
2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
290721
Title
DMF 32s23
Study date
2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
290727
Title
DMF 32s42
Study date
2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
290724
Title
DMF 32s26
Study date
2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
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
290733
Title
DMF 32s5
Study date
2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
290722
Title
DMF 32s24
Study date
2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
290730
Title
DMF 32s433
Study date
2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Data no
290719
Title
DMF 32s1
Study date
2024
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK 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
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
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
268521
Title
3.2.S.4.1 Specification
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
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
268533
Title
API DMF
Study date
2024
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
268524
Title
CoA reference standard 1
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
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
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
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
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
268496
Title
DMF 2.3.S
Study date
2021
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
268499
Title
3.2.S.1.2 Structure
Study date
2024
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
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
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
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
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
268494
Title
Certificates of analysis for active constituent
Study date
2021
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
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
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
268497
Title
3.2.S.1.1 Nomenclature
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
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
268520
Title
3.2.S.7.3 Stability data
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
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
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
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
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
268526
Title
CoA reference standard 2
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
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
268495
Title
ASMF - D180 LoOI Responses
Study date
2021
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
Date
Application Date
Application No
Application Number
145426
Product/Active constituent Name
Application Product Name
VERSYS INSECTICIDE
Application Date
Application Number
145426
Application Product Name
VERSYS INSECTICIDE
Application details
Product name:
VERSYS INSECTICIDE
Product number:
82738
Applicant Name:
BASF AUSTRALIA LTD.
Application purpose and description of use:
Variation of product registration and label approval for extension of use into apple and pear. This application includes uses that, if granted, may trigger an extension to the limitation period.
Active constituents:
Active constituent name
82739 - AFIDOPYROPEN
Description of data provided:
Data no
278700
Title
BAS 440I/apple/dimpling bug control
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278706
Title
Efficacy of BAS 55001I at Controlling Long Tailed Mealybugs in a Pear Orchard
Study date
2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278697
Title
Evaluation the efficacy of BAS 550UGI and BAS 440 00I insecticide for the control of long tailed mealybugs in pear
Study date
2017
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278703
Title
BAS 550I/apple/dimpling bug control
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278709
Title
Trial Reference: NAS-WA-23-DB-I06
Study date
2023
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278698
Title
Efficacy of BAS 440 00I 100 DC for apple dimpling bug (Campylomma liebknechti) control in apples cv. Red Delicious
Study date
2019
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278704
Title
Evaluate the efficacy of BAS 550 01I on the control of Apple Dimpling Bug
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278712
Title
Determination of residues of afidopyropen in pome fruit following four foliar applications of BAS 440 00 I
Study date
2024
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278701
Title
Evaluate the efficacy of BAS 440 00I on the control of Apple Dimpling Bug
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278695
Title
Evaluate the efficacy and the most effective rate of BAS 440 00I on the control of Apple Dimpling Bug
Study date
2017
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278715
Title
Evaluation of Processed Food/Feed (PF) Residues of BAS 440 I in Appl
Study date
2016
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278696
Title
Evaluation the efficacy of BAS 550 UGI and BAS 440 00I insecticide for the control of long tailed mealybugs in pear
Study date
2017
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278710
Title
Part 8 Effiacy & Crop Safety Dossier Summary
Study date
2024
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278699
Title
Comparison of BAS 440 00I 100 DC +/- Agral 600 SL with Calypso 480 SC for the control of apple dimpling bug (Campylomma liebknechti) and western flower thrips (Frankliniella occidentalis) in apples cv. Smitten
Study date
2019
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278707
Title
Comparison of BAS 550 01I 120 SL +/- BAS 440 00I 100 DC or BAS 480 03I 76.8 OD, BAS 440 00I and BAS 480 03I 76.8 with Calypso 480 SC for the control of apple dimpling bug (Campylomma liebknechti) in pears cv. Packham?s Triumph
Study date
2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278713
Title
Part 5B Residues Trade Summary Dossier
Study date
2024
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278702
Title
Evaluate the efficacy of BAS 440 00I on the control of Apple Dimpling Bug
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278708
Title
Evaluate the efficacy of BAS 5500I on the control of Apple Dimpling Bug
Study date
2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278714
Title
Part 5A Residues Summary Dossier
Study date
2024
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278705
Title
Evaluate the efficacy of BAS 550 01I on the control of Apple Dimpling Bug
Study date
2021
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
278711
Title
Determination of residues of BAS440 in pome fruit following four foliar applications of BAS 440 00 I Australia 2022-2023
Study date
October 2023
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Date
Application Date
Application No
Application Number
145310
Product/Active constituent Name
Application Product Name
Daxocox 30mg tablets for dogs
Application Date
Application Number
145310
Application Product Name
Daxocox 30mg tablets for dogs
Application details
Product name:
Daxocox 30mg tablets for dogs
Product number:
95333
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 30mg enflicoxib tablet product for use in dogs, in conjunction with approval of enflicoxib.
Active constituents:
Active constituent name
95331 - Enflicoxib (INN)
Date
Application Date
Application No
Application Number
145457
Product/Active constituent Name
Application Product Name
MILBEMAX TABLETS FOR CATS
Application Date
Application Number
145457
Application Product Name
MILBEMAX TABLETS FOR CATS
Application details
Product name:
MILBEMAX TABLETS FOR CATS
Product number:
54265
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of product label approval to increase dose frequency, enhance clarity and incorporate sustainability initiatives in disposal section.
Active constituents:
Active constituent name
84391 - PRAZIQUANTEL
Date
Application Date
Application No
Application Number
145456
Product/Active constituent Name
Application Product Name
MILBEMAX TABLETS FOR SMALL CATS
Application Date
Application Number
145456
Application Product Name
MILBEMAX TABLETS FOR SMALL CATS
Application details
Product name:
MILBEMAX TABLETS FOR SMALL CATS
Product number:
54264
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of product label approval to increase dose frequency, enhance clarity and incorporate sustainability initiatives in disposal section.
Active constituents:
Active constituent name
84391 - PRAZIQUANTEL
Description of data provided:
Data no
278434
Title
RLPs
Study date
2024
Auth party contact address
-
Data no
282931
Title
Part 8 Efficacy Safety Milbemax Final
Study date
20 Dec 2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278432
Title
Companion Animal Zoonoses Guidelines
Study date
2024
Data no
282932
Title
s159 response
Study date
2024
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
278433
Title
Chemistry, Pharmacology and Safety: Milbemyin Oxime
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
282930
Title
Guidelines for the diagnosis treatment and control of feline endoparasites in the tropics.
Study date
17 March 2019
Date
Application Date
Application No
Application Number
145693
Product/Active constituent Name
Application Product Name
Randlab Vitamin B1 Injection
Application Date
Application Number
145693
Application Product Name
Randlab Vitamin B1 Injection
Application details
Product name:
Randlab Vitamin B1 Injection
Product number:
95439
Applicant Name:
RANDLAB AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a Randlab vitamin B1 injection containing 125mg/mL thiamine hydrochloride as supplement for horses and dogs.
Reference details:
49860 - NV VITAMIN B1 INJECTION
Active constituents:
Active constituent name
57667 - VITAMIN B1
Description of data provided:
Data no
278740
Title
Finished Product Specification
Study date
03 Oct 2024
Auth party contact address
71 Milperra Road Revesby Australia
Date
Application Date
Application No
Application Number
145309
Product/Active constituent Name
Application Product Name
Daxocox 15mg tablets for dogs
Application Date
Application Number
145309
Application Product Name
Daxocox 15mg tablets for dogs
Application details
Product name:
Daxocox 15mg tablets for dogs
Product number:
95332
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 15mg enflicoxib tablet product for use in dogs, in conjunction with approval of enflicoxib.
Active constituents:
Active constituent name
95331 - Enflicoxib (INN)
Description of data provided:
Data no
277489
Title
Health Summary
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277587
Title
Systematic review of the management of canine osteoarthritis
Study date
2009
Auth party contact address
-
Data no
277564
Title
Report T-99/03
Study date
April 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277541
Title
Report CD-98/6419FC
Study date
January 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277518
Title
Report FI-00/01-SN
Study date
January 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277495
Title
Appendic 2B.3-1
Study date
June 2013
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277604
Title
Report EV-18/18
Study date
July 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277512
Title
Report AI-99/12-SN
Study date
September 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277558
Title
Report CD-98/6399FD
Study date
February 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277501
Title
Certificates of Analysis
Study date
2023
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277575
Title
Report T-98/08
Study date
April 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277552
Title
Report 113518
Study date
November 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277524
Title
Report 111018
Study date
July 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277595
Title
Report PK_001_2018
Study date
July 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277532
Title
Report BM-99/03
Study date
July 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277544
Title
Report S27766
Study date
July 2010
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
278365
Title
GMP Certificate 2023
Study date
2023
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277581
Title
Report CD-99/6507FD
Study date
April 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277538
Title
Report BM-01/31-SN
Study date
April 2003
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277561
Title
Report T-99/04
Study date
December 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277492
Title
Certificate of GMP
Study date
June 2022
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277515
Title
Report AI-99/04-SN
Study date
January 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277555
Title
Report BM-00/16
Study date
March 2003
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277601
Title
Report PK_001_2020
Study date
January 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277607
Title
CVMP assessment report for Daxocox (EMEA/V/C/005354/0000)
Study date
April 2021
Auth party contact address
-
Data no
277598
Title
Report DA/197/C
Study date
December 2018
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277504
Title
Certificates of Analysis
Study date
January 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277498
Title
Quality Documentation Part 2D Control Tests
Study date
January 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277572
Title
Report CD-98/6369T
Study date
May 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277521
Title
Report BM-99/19-SN
Study date
February 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277578
Title
Report CD-98/6397FD
Study date
March 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277535
Title
Report BM-00/02
Study date
April 2002
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277584
Title
Report 123219
Study date
January 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277610
Title
Summary of Opinion
Study date
February 2021
Auth party contact address
-
Data no
277516
Title
Report AI-99/03-SN
Study date
June 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277539
Title
Report BM-01/20
Study date
December 2004
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277493
Title
Quality Documentation Part 2A Qualitative Particulars
Study date
January 2021
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277556
Title
Report BM-00/09
Study date
March 2002
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277602
Title
Report ONDAX (DA/184/C and DA/197/C)
Study date
July 2018
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277510
Title
Report S40772
Study date
October 2013
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277550
Title
Report BM-00/29-SN
Study date
November 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277573
Title
Report T-13/02
Study date
May 2015
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277599
Title
Report BM-16/39
Study date
October 2017
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277499
Title
Quality Documentation Part 2G Other Information
Study date
January 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277593
Title
Report BM-13/06-SN
Study date
May 2013
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277579
Title
Report CD-98/6396FD
Study date
February 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277487
Title
Safety Data
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277530
Title
Report BM-98/20
Study date
May 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277536
Title
Report CRO-PK-01-48
Study date
November 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277513
Title
Report SNEC-13/12-SN
Study date
May 2018
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277490
Title
Environment Summary
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277519
Title
Report A113483
Study date
October 2012
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277496
Title
Quality Documentation Part 2C2 Starting Materials
Study date
February 2021
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277567
Title
Report CD-98/6359T
Study date
September 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277553
Title
Report BM-99/08
Study date
June 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277559
Title
Report BM-99/30-SN
Study date
November 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277507
Title
Report FBIO-01/01-SN
Study date
October 2002
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277527
Title
Report BM-12/14
Study date
June 2014
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277576
Title
Report T-13/01
Study date
April 2015
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277547
Title
Report BM-98/22
Study date
July 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277596
Title
Report DA/184/C
Study date
January 2016
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277570
Title
Report CD-99/6639T
Study date
December 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277590
Title
Report BM-12/09-SN
Study date
April 2013
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277484
Title
Application Summary
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277533
Title
Report BM-00/01-SN
Study date
April 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277582
Title
Report 0538/051-D6146
Study date
July 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277491
Title
Certificate of GMP
Study date
Dec 2023
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277562
Title
Report T-98/06
Study date
January 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277585
Title
Report 123019
Study date
January 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277514
Title
Report AI-99/13-SN
Study date
May 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277568
Title
Report CD-98/6360T
Study date
January 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277554
Title
Report CD-98/6361FD
Study date
December 1998
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277608
Title
Safety Data Sheet
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277508
Title
Report SNEC-13/11-SN
Study date
May 2014
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277597
Title
Report BM-14/20
Study date
October 2016
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277528
Title
Report BM-12/13
Study date
June 2014
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277571
Title
Report CD-99/6640T
Study date
December 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277548
Title
Report BM-00/11
Study date
October 2003
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277522
Title
Report BM-01/16-SN
Study date
February 2002
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277485
Title
Chemistry and Manufacture Summary Product
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277591
Title
Report BM-12/10-SN
Study date
May 2013
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277577
Title
Report CD-98/6393FD
Study date
March 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277534
Title
Report BM-00/17
Study date
September 2002
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277611
Title
Summary of Product Characteristics
Study date
February 2021
Auth party contact address
-
Data no
277588
Title
Use of non-steroidal anti-inflammatory drugs for the treatment of canine osteoarthritis
Study date
2010
Auth party contact address
-
Data no
277565
Title
Report CD-98/6358T
Study date
December 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277542
Title
Report BM-99/16
Study date
April 2002
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277505
Title
Detailed and Critical Summary on the Pharmaceutical Documentation
Study date
January 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277511
Title
Report AI 99/06-SN
Study date
May 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277605
Title
Comparison of oral robenacoxib and carprofen for the treatment of osteoarthritis in dogs: a randomised clinical trial
Study date
2012
Auth party contact address
-
Data no
277574
Title
Report T-98/07
Study date
April 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277525
Title
Report 112318
Study date
October 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277502
Title
Quality Documentation Part 2F2 Stability Finished Product
Study date
October 2023
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277551
Title
Report AT18P2501-01
Study date
January 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277545
Title
Report TH180077
Study date
January 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277594
Title
Report EV-013/09-SN
Study date
December 2016
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277488
Title
Efficacy Data
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277531
Title
Report BM-99-06-SN
Study date
October 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277537
Title
Report BM-01/24
Study date
August 2004
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277589
Title
A pharmacokinetic / pharmacodynamic approach vs. a dose titration for the determination of a dosage regimen: the case of nimesulide, a Cox-2 selective nonsteroidal anti-inflammatory drug in the dog
Study date
2001
Auth party contact address
-
Data no
277566
Title
Report T-00/08
Study date
March 2003
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277543
Title
Report BM-10/24-SN
Study date
October 2011
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277520
Title
Report A123936
Study date
December 2012
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277497
Title
Quality Documentation Part 2C4 Starting Materials
Study date
December 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277506
Title
Report AI-99/01-SN
Study date
October 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277560
Title
Report T-98/05
Study date
February 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277606
Title
Pharmacokinetics, pharmacodynamics, toxicology and therapeutics of mavacoxib in the dog: a review
Study date
2014
Auth party contact address
-
Data no
277503
Title
Quality Documentation Part 2C3 Packaging
Study date
January 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277526
Title
Report 112218
Study date
July 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277546
Title
Report A186725
Study date
May 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277569
Title
Report VX05LK
Study date
September 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277583
Title
Report 123119
Study date
December 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277483
Title
Cover Letter
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277586
Title
Report 136720
Study date
July 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277609
Title
ENVIRONMENTAL IMPACT ASSESSMENT (EIAS) FOR VETERINARY MEDICINAL PRODUCTS (VMPS) - PHASE I
Study date
June 2000
Auth party contact address
-
Data no
277540
Title
Chirality, 16: 302-308
Study date
2004
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277563
Title
Report T-99/05
Study date
March 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277494
Title
Quality Documentation Part 2B Manufacture
Study date
December 2023
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277517
Title
Report AI-99/07-SN
Study date
March 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277509
Title
Report 284110
Study date
February 2000
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277603
Title
Report EV-19/01-SN
Study date
July 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277557
Title
Report BM-99/15
Study date
November 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277549
Title
Report 118419
Study date
November 2019
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277600
Title
Report PK_001_2019
Study date
January 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277500
Title
Quality Documentation Part 2E Finished Product Tests
Study date
November 2020
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277523
Title
Report BM-01/18-SN
Study date
March 2003
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277580
Title
Report CD-98/6398FD
Study date
February 1999
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277592
Title
Report BM-10/28
Study date
October 2016
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277486
Title
Efficacy and Safety Summary
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277529
Title
Report BM-98/21
Study date
June 2001
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Date
Application Date
Application No
Application Number
145313
Product/Active constituent Name
Application Product Name
Daxocox 45mg tablets for dogs
Application Date
Application Number
145313
Application Product Name
Daxocox 45mg tablets for dogs
Application details
Product name:
Daxocox 45mg tablets for dogs
Product number:
95334
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 45mg enflicoxib tablet product for use in dogs, in conjunction with approval of enflicoxib.
Active constituents:
Active constituent name
95331 - Enflicoxib (INN)
Date
Application Date
Application No
Application Number
145320
Product/Active constituent Name
Application Product Name
Daxocox 70mg tablets for dogs
Application Date
Application Number
145320
Application Product Name
Daxocox 70mg tablets for dogs
Application details
Product name:
Daxocox 70mg tablets for dogs
Product number:
95340
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 70mg enflicoxib tablet product for use in dogs, in conjunction with approval of enflicoxib.
Active constituents:
Active constituent name
95331 - Enflicoxib (INN)
Date
Application Date
Application No
Application Number
145321
Product/Active constituent Name
Application Product Name
Daxocox 100mg tablets for dogs
Application Date
Application Number
145321
Application Product Name
Daxocox 100mg tablets for dogs
Application details
Product name:
Daxocox 100mg tablets for dogs
Product number:
95341
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 100mg enflicoxib tablet product for use in dogs, in conjunction with approval of enflicoxib.
Active constituents:
Active constituent name
95331 - Enflicoxib (INN)
Date
Application Date
Application No
Application Number
142476
Product/Active constituent Name
Application Product Name
1,4-dimethylnaphthalene
Application Date
Application Number
142476
Application Product Name
1,4-dimethylnaphthalene
Application details
Product name:
1,4-dimethylnaphthalene
Product number:
94459
Applicant Name:
1,4 GROUP, INC.
Application purpose and description of use:
Registration of a 980 g/L liquid formulation of 1,4-dimethylnapthalene to enhance dormancy of potatoes in storage as per the Directions For Use Table (product 94460-142477
Description of data provided:
Data no
265086
Title
Final Addendum to the Draft Assessment Report (DAR) 1,4-Dimethylnapthalene
Study date
April 2013
Auth party contact address
-
Data no
265026
Title
Reverse Mutation in 5ive histidine-requiring strains of Salmonella typhimurium
Study date
July 2007
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265003
Title
Henrys Law Calculation 14DMN and impurities
Study date
2024
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
264995
Title
Executive Summary
Study date
November 2023
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265006
Title
Determination and Characterisation of 1,4-dimethylnapthalene in Five Production Batches (2019)
Study date
23 May 2023
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265029
Title
Measurement of Unscheduled DNA synthesis in rat liver using an in vivo/in vitro procedure
Study date
November 2007
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265021
Title
90 Day Oral Toxicity Study of 1,4-Dimethylnapthalene in Rats
Study date
25 September 2003
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
286060
Title
Process Flow Chart & Quality Control
Study date
April 2025
Auth party contact address
NO.12 FUQIANG ROAD, ECONOMIC DEVELOPMENT ZONE OF CI COUNTY, HANDAN CITY, HEBEI 056500, CHINA
Data no
265001
Title
1,4-DMN Determination of Surface Tension
Study date
19 February 2021
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265007
Title
Description and Validation of an Enforcement Analytical Method for the Determination of the Active Ingredient and Significant Impurities in the Technical Grade 1,4- dimethylnapthaleneetermination and Characterisation of 1,4-dimethylnapthalene (2020)
Study date
26 August 2020
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265030
Title
In vitro percutaneous absorption of 1,4-dimethlynapthalene through human skin
Study date
23 April 2009
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265024
Title
Oral Developmental Toxicity Study of 1,4-Dimethylnaphthalene in Rabbits
Study date
31 March 2011
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265018
Title
Acute Dermal Toxicity of 1,4-dimethylnapthalene (1,4-DMN) in Rabbits (Limit Test)
Study date
October 1993
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265027
Title
Mutagenicity Test on 1,4-dimethylnapthalene in vivo mouse micronucleus assay
Study date
24 August 1993
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265004
Title
Manufacturing process
Study date
2022
Auth party contact address
No 12 Fuqiang Road, Economic Development Zone of CI County, Handan City, Hebei 056500 China
Data no
264998
Title
1,4-DMN Solubility
Study date
16 December 2023
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265019
Title
Acute Inhalation Toxicity of 1,4-dimethylnapthalene (1,4-DMN) in Rats
Study date
October 1993
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265005
Title
Declaration of Composition
Study date
December 2023
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265028
Title
Genotoxicity Test on 1,4-dimethylnapthalene in the assay for unscheduled DNA synthesis in Rat Liver primary cell cultures
Study date
28 September 1993
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
264999
Title
Determination of the Solubility of 1,4-Dimethylnapthalene in Organic Solvents by the Shake Glass Method
Study date
1 December 2005
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265022
Title
Extended One Generation Reproductive Toxicity Study of 1,4-DMN Administered Orally to Rats
Study date
31 March 2011
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
286061
Title
Impurities Discussion
Study date
April 2025
Auth party contact address
NO.12 FUQIANG ROAD, ECONOMIC DEVELOPMENT ZONE OF CI COUNTY, HANDAN CITY, HEBEI 056500, CHINA
Data no
265016
Title
Part 3 Toxicology
Study date
December 2023
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265002
Title
Calculation of Henry's Law Constant for 1,4-Dimethylnapthalene
Study date
18 November 2003
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265025
Title
Mutagenicity Test of 1,4-Dimethylnaphthane in the Salmonella/Mammalian-Microsome Reverse Mutation Assay (Ames Test)
Study date
21 September 1993
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
264996
Title
1,4-DMN Batch H5510 -Clor, Physical Statment, Odor, Boiling Point, Specific Gravity, pH, Flammability, Impact Explodability, Viscosity
Study date
12 November 1993
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265017
Title
S.K. Shults, A.V. Brock, J. Laveglia
Study date
27 October 1993
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265023
Title
Oral (Diet Admixture) Combined Chronic Toxicity/ Carcinogenicity Study of 1,4- Dimethylnapthalene in Rats
Study date
3 March 2011
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
286062
Title
1,4-DMN Stability
Study date
10 December 1993
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
264997
Title
1,4-DMN Vapor Pressure
Study date
14 December 1993
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265020
Title
Dermal Sensitization Study of 1,4-dimethylnapthalene (1,4-DMN) in Guinea Pigs using the modified Buehler Method
Study date
October 1993
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Data no
265000
Title
Determination of explosive properties and oxidizing properties for 1,4-Dimethylnapthalene (expert statement)
Study date
18 November 2003
Auth party contact address
2307 E Commercial St, Ste A MERIDIAN United States
Date
Application Date
Application No
Application Number
145308
Product/Active constituent Name
Application Product Name
Enflicoxib (INN)
Application Date
Application Number
145308
Application Product Name
Enflicoxib (INN)
Application details
Product name:
Enflicoxib (INN)
Product number:
95331
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a 15mg enflicoxib tablet product for use in dogs, in conjunction with approval of enflicoxib.
Description of data provided:
Data no
277618
Title
Quality Documentation Part 2F1 Stability Active
Study date
May 2023
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277615
Title
Quality Documentation Part 2C1 Active
Study date
February 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277616
Title
Appendix 2C.1-1 Active Substance Master File
Study date
January 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277614
Title
Chemistry and Manufacture Summary Active
Study date
August 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
277617
Title
Active Substance Master File
Study date
January 2023
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Date
Application Date
Application No
Application Number
145440
Product/Active constituent Name
Application Product Name
FireHawk Bioherbicide Super Concentrate
Application Date
Application Number
145440
Application Product Name
FireHawk Bioherbicide Super Concentrate
Application details
Product name:
FireHawk Bioherbicide Super Concentrate
Product number:
95387
Applicant Name:
CONTACT BIOSOLUTIONS PTY LTD
Application purpose and description of use:
Registration of a 777g/L nonanoic acid emulsifiable concentrate non-selective herbicide for the control of weeds in public areas including parks, curbs, verges, playgrounds, gardens, schools, sporting grounds, nurseries, bushland, fence lines, and other situations as per the Directions for Use.
Description of data provided:
Data no
278723
Title
Appendix 4 Active and Excipient SDS
Study date
2024
Auth party contact address
-
Data no
278729
Title
Evaluation of FireHawk Bioherbicide Super Concentrate and FireHawk Bioherbicide Plus Ready to Use Spray Mixture for seedling weed control in fallow, Forth, Tasmania, 2024
Study date
15 May 2024
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278720
Title
Appendix 1 Sales Specification Pelargonic acid
Study date
15 May 2020
Auth party contact address
-
Data no
287594
Title
FireHawk Bioherbicide SC S159 Response
Study date
20 June 2025
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278726
Title
Derivation of Mammalian Toxicity Classifications for FireHawk Bioherbicide Super Concentrate
Study date
30 May 2024
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278721
Title
Appendix 2 OQ Chemicals Nonanoic Acid/ / Pelargonic Acid Certificate of Analysis Batch P0621430AP
Study date
24 May 2021
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278718
Title
FireHawk Bioherbicide Super Concentrate PART 2 Chemistry and Manufacture
Study date
15 July 2024
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278724
Title
Appendix 5 Determination of Nonanoic Acid in EC Formulations ( 700 - 800 gL Nonanoic acid)
Study date
16 July 2024
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278727
Title
Derivation of Ecotoxicology Endpoints for FireHawk Bioherbicide Super Concentrate
Study date
3 June 2024
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278730
Title
Evaluation of FireHawk Bioherbicide Super Concentrate herbicide (777g/L Nonanoic Acid) and FireHawk Bioherbicide Plus Ready to Use Spray Mixture for control of seedling broadleaf and grass weeds.
Study date
May 2024
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278719
Title
FireHawk Bioherbicide Super Concentrate STABILITY DATA
Study date
15 July 2024
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
287593
Title
FireHawk Bioherbicide Super Concentrate PART 8 Efficacy and Crop Safety
Study date
20 June 2025
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278725
Title
91093-130918 & 91097-130925 Contact Organics LocalSafe & FarmSafe Weed Terminator N - HHRA FTR
Study date
11 February 2022
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278722
Title
Appendix 3 Exempt Status of Nonanoic Acid
Study date
26 November 2020
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
278728
Title
Evaluation of FireHawk Bioherbicide Super Concentrate and FireHawk Bioherbicide Plus Ready to Use Spray Mixture for the control of seedling, broadleaf and grass weed,s Sharon, Queensland, 2024
Study date
8 May 2024
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Date
Application Date
Application No
Application Number
145567
Product/Active constituent Name
Application Product Name
FireHawk Bioherbicide Plus Ready to Use Spray Mixture
Application Date
Application Number
145567
Application Product Name
FireHawk Bioherbicide Plus Ready to Use Spray Mixture
Application details
Product name:
FireHawk Bioherbicide Plus Ready to Use Spray Mixture
Product number:
95418
Applicant Name:
CONTACT BIOSOLUTIONS PTY LTD
Application purpose and description of use:
Registration of a 28 g/L nonanoic acid aqueous emulsion (EW), non--selective herbicide for control of weeds in home gardens as per the Directions for Use.
Reference details:
85722 - Contact Organics LocalSafe Weed Terminator Concentrate Herbicide
Description of data provided:
Data no
279055
Title
Evaluation of FireHawk Bioherbicide Super Concentrate and FireHawk Bioherbicide Plus Ready to Use Spray Mixture for the control of seedling broadleaf and grass weeds Sharon, Queensland, 2024
Study date
8 May 2024
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
290631
Title
S159 Response Re. FireHawk Bioherbicide Plus Spray Mixture Product 95418
Study date
10 August 2025
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
279052
Title
91093-130918 & 91097-130925 Contact Organics LocalSafe & FarmSafe Weed Terminator N - HHRA FTR
Study date
11 February 2022
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
279047
Title
Sales Specification Pelargonic acid
Study date
15 May 2020
Auth party contact address
-
Data no
279053
Title
Derivation of Mammalian Toxicity Classifications for FireHawk Bioherbicide Plus Ready-To-Use Spray Mixture
Study date
30 May 2024
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
279056
Title
Evaluation of FireHawk Bioherbicide Super Concentrate and FireHawk Bioherbicide Plus Ready to Use Spray Mixture for seedling weed control in fallow, Forth, Tasmania, 2024
Study date
15 May 2024
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
279050
Title
Appendix 4 Active and Excipient SDS
Study date
2024
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
279045
Title
FireHawk Bioherbicide Plus Ready to Use Spray Mixture PART 2 Chemistry and Manufacture
Study date
16 July 2024
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
279051
Title
Appendix 5 Determination of Nonanoic Acid in EW Formulations
Study date
16 July 2024
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
290632
Title
FireHawk Bioherbicide Plus RTU Spray Mixture Formulation Details Product 95418
Study date
15 August 2025
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
279048
Title
Appendix 2 OQ Chemicals Nonanoic AcidPelargonic Acid Certificate of Analysis Batch P0621430AP
Study date
24 May 2021
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
279054
Title
Derivation of Ecotoxicology Endpoints for FireHawk Bioherbicide Plus Ready-To-Use Spray Mixture
Study date
3 June 2024
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
279049
Title
Appendix 3 Exempt Status of Nonanoic Acid
Study date
26 November 2020
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
279057
Title
Evaluation of FireHawk Bioherbicide Super Concentrate herbicide (777g/L Nonanoic Acid) and FireHawk Bioherbicide Plus Ready to Use Spray Mixture for control of seedling broadleaf and grass weeds
Study date
May 2024
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia
Data no
279046
Title
FireHawk Bioherbicide Plus Ready to Use Spray Mixture STABILITY DATA
Study date
16 July 2024
Auth party contact address
Suite 43, 45 Riversdale Road Hawthorn Australia