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
143925
Product/Active constituent Name
Application Product Name
Tranexamic Acid
Application Date
Application Number
143925
Application Product Name
Tranexamic Acid
Application details
Product name:
Tranexamic Acid
Active name:
Tranexamic Acid
Applicant Name:
PROBUS PHARMACEUTICALS PTY LTD
Application purpose and description of use:
new source of pharmacopoeia active constituent
Description of data provided:
Data no
271434
Title
CAM 01 COA
Study date
2023
Auth party contact address
10/222 Wiseman Ferry Road Somersby Australia
Date
Application Date
Application No
Application Number
143951
Product/Active constituent Name
Application Product Name
Euthaject 325mg/mL Sterile Injectable Pentobarbitone Sodium for Rapid Euthanasia
Application Date
Application Number
143951
Application Product Name
Euthaject 325mg/mL Sterile Injectable Pentobarbitone Sodium for Rapid Euthanasia
Application details
Product name:
Euthaject 325mg/mL Sterile Injectable Pentobarbitone Sodium for Rapid Euthanasia
Product number:
94887
Applicant Name:
PROBUS PHARMACEUTICALS PTY LTD
Application purpose and description of use:
Registration of a 325mg/mL Injectable Pentobarbitone sodium for rapid euthanasia of dogs and cats.
Reference details:
47815 - LETHABARB EUTHANASIA INJECTION
Description of data provided:
Data no
277435
Title
Revised product specifications
Study date
August 2024
Auth party contact address
10/222 Wiseman Ferry Road Somersby Australia
Data no
271500
Title
Release Specifications
Study date
2024
Auth party contact address
10/222 Wiseman Ferry Road Somersby Australia
Date
Application Date
Application No
Application Number
144501
Product/Active constituent Name
Application Product Name
Fostera Gold PCV Metastim
Application Date
Application Number
144501
Application Product Name
Fostera Gold PCV Metastim
Application details
Product name:
Fostera Gold PCV Metastim
Product number:
88614
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
The purpose of this applications is to update the approved labels to include an alternative intramuscular method of administration, using needle free devices, for Fostera Gold PCV MH and the registered fallout vaccine, Fostera Gold PCV Metastim.
Active constituents:
Active constituent name
83556 - Porcine Circovirus Type 1-Type 2a Chimera Inactivated
Active constituent name
87926 - Porcine Circovirus Type 1-Type 2b Chimera Inactivated
Date
Application Date
Application No
Application Number
144746
Product/Active constituent Name
Application Product Name
Boostimin Injection for Cattle
Application Date
Application Number
144746
Application Product Name
Boostimin Injection for Cattle
Application details
Product name:
Boostimin Injection for Cattle
Product number:
87905
Applicant Name:
NUTRIEN AG SOLUTIONS LIMITED
Application purpose and description of use:
Variation of product registration details
Active constituents:
Active constituent name
83582 - Copper Carbonate
Active constituent name
83576 - EDTA (acid)
Active constituent name
83580 - Manganese Carbonate
Active constituent name
83575 - Sodium Selenite
Active constituent name
83577 - DISODIUM ZINC EDTA
Active constituent name
83578 - DISODIUM MANGANESE EDTA
Active constituent name
83581 - DISODIUM COPPER EDTA
Description of data provided:
Data no
274398
Title
Letter of support
Study date
October 2024
Date
Application Date
Application No
Application Number
144748
Product/Active constituent Name
Application Product Name
Nutriject Injection for Cattle
Application Date
Application Number
144748
Application Product Name
Nutriject Injection for Cattle
Application details
Product name:
Nutriject Injection for Cattle
Product number:
87829
Applicant Name:
NUTRIEN AG SOLUTIONS LIMITED
Application purpose and description of use:
Variation of product registration details
Active constituents:
Active constituent name
83580 - Manganese Carbonate
Active constituent name
83582 - Copper Carbonate
Active constituent name
83576 - EDTA (acid)
Active constituent name
83581 - DISODIUM COPPER EDTA
Active constituent name
83575 - Sodium Selenite
Active constituent name
83577 - DISODIUM ZINC EDTA
Active constituent name
83578 - DISODIUM MANGANESE EDTA
Date
Application Date
Application No
Application Number
144699
Product/Active constituent Name
Application Product Name
Quad Multi-Combination Sheep Drench
Application Date
Application Number
144699
Application Product Name
Quad Multi-Combination Sheep Drench
Application details
Product name:
Quad Multi-Combination Sheep Drench
Applicant Name:
FOUR SEASONS AGRIBUSINESS PTY LTD
Application purpose and description of use:
Registration of a 37.5 g/L closantel, 34 g/L levamisole (as levamisole hydrochloride), 25 g/L albendazole, 1 g/L abamectin oral suspension product for the treatment and control of worms in sheep.
Date
Application Date
Application No
Application Number
143920
Product/Active constituent Name
Application Product Name
Thromboguard 100 mg/mL Injectable Tranexamic Acid for Horses
Application Date
Application Number
143920
Application Product Name
Thromboguard 100 mg/mL Injectable Tranexamic Acid for Horses
Application details
Product name:
Thromboguard 100 mg/mL Injectable Tranexamic Acid for Horses
Product number:
94874
Applicant Name:
PROBUS PHARMACEUTICALS PTY LTD
Application purpose and description of use:
Registration of a 100mg/mL tranexamic acid injectable solution product for the control of bleeding in horses.
Reference details:
51210 - ILIUM TRANEXAMIC ACID INJECTION
Active constituents:
Active constituent name
94876 - Tranexamic Acid
Description of data provided:
Data no
271433
Title
CAM 03 Quality Control
Study date
2024
Auth party contact address
10/222 Wiseman Ferry Road Somersby Australia
Data no
271432
Title
CAM 02 Workflow
Study date
2024
Auth party contact address
10/222 Wiseman Ferry Road Somersby Australia
Date
Application Date
Application No
Application Number
144511
Product/Active constituent Name
Application Product Name
Equicort QLD Itch Treatment for Horses
Application Date
Application Number
144511
Application Product Name
Equicort QLD Itch Treatment for Horses
Application details
Product name:
Equicort QLD Itch Treatment for Horses
Product number:
93039
Applicant Name:
DERMCARE-VET PTY. LTD.
Application purpose and description of use:
Variation of product label approval to amend Dosage and Administration instructions and Precaution Statement.
Active constituents:
Active constituent name
86010 - PERMETHRIN (25:75 CIS:TRANS)
Active constituent name
82110 - Budesonide
Description of data provided:
Data no
281444
Title
s159_response_equicort_20112024
Study date
2024
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
281905
Title
s159_response_equicort_12122024
Study date
2024
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
273532
Title
ApplicationDoseDeriv_2018
Study date
2024
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
273533
Title
Handsizestudy_2018
Study date
2024
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
273531
Title
Summary for label changes
Study date
2024
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Date
Application Date
Application No
Application Number
144753
Product/Active constituent Name
Application Product Name
clodinafop propargyl
Application Date
Application Number
144753
Application Product Name
clodinafop propargyl
Application details
Product name:
clodinafop propargyl
Active name:
clodinafop propargyl
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of Clodinafop-propargyl for use in agricultural products.
Description of data provided:
Data no
274405
Title
Analytical Method SA-67/2 for Clodinafop-propargyl (CGA 184927) tech. - Assay by capillary GC / chiral HPLC
Study date
06 December 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
274406
Title
Analytical Method 58-67/2 for Clodinafop-propargyl (CGA184927) tech. By-products and supplementary tests
Study date
06 December 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
274404
Title
Clodinafop-propargyl - Analysis of Five Representative Batches
Study date
29 January 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
274402
Title
MANUFACTURING PROCESS, CLODINAFOP-PROPARGYL
Study date
07 June 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
274403
Title
Declaration of composition
Study date
08 July 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
274400
Title
Part 2 - Chemistry and Manufacture
Study date
11 July 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
274401
Title
Report on NMR Spectra
Study date
04 June 2024
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
274407
Title
Clodinafop-propargyl ??? Validation of Analytical Method SA-67/2
Study date
23 November 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Data no
274408
Title
Clodinafop-propargyl ??? Validation of Analytical Method SB-67/2
Study date
05 December 2023
Auth party contact address
LEVEL 1, 2 LYONPARK ROAD MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
144502
Product/Active constituent Name
Application Product Name
Fostera Gold PCV MH
Application Date
Application Number
144502
Application Product Name
Fostera Gold PCV MH
Application details
Product name:
Fostera Gold PCV MH
Product number:
87927
Applicant Name:
ZOETIS AUSTRALIA PTY LTD
Application purpose and description of use:
The purpose of this applications is to update the approved labels to include an alternative intramuscular method of administration, using needle free devices, for Fostera Gold PCV MH and the registered fallout vaccine, Fostera Gold PCV Metastim.
Active constituents:
Active constituent name
83556 - Porcine Circovirus Type 1-Type 2a Chimera Inactivated
Active constituent name
87926 - Porcine Circovirus Type 1-Type 2b Chimera Inactivated
Active constituent name
83587 - MYCOPLASMA HYOPNEUMONIAE INACTIVATED
Description of data provided:
Data no
273460
Title
B920R-US-22-B80 Study report
Study date
May 2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273461
Title
B920R-US-22-B81 Study report
Study date
May 2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273462
Title
B920R-US-22-B82 Study report
Study date
May 2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273463
Title
Non-Inferiority Field Study Comparing the Administrations by Conventional Needle-Syringe and Needle-Free Injectors of a Trivalent Vaccine Containing Porcine Circovirus Types 2a/2b and Mycoplasma hyopneumoniae
Study date
2022
Auth party contact address
-
Data no
273457
Title
Applicant's response to questions
Study date
19 Apr 2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273448
Title
Part 8 Efficacy and Safety Summary
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273465
Title
Certificate of Analysis B/N 413369A
Study date
2020
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273466
Title
Certificate of Analysis B/N 565224A
Study date
2022
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273467
Title
Manufacturer's declaration
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273468
Title
OOP 49K5.R7
Study date
Oct 2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273469
Title
OOP 19K5.R1
Study date
Oct 2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273470
Title
Food Hygiene (Basic Texts), Fourth Edition
Study date
2009
Auth party contact address
-
Data no
273471
Title
Composition of some metallic fragments found in food that are undetectable by magnetic or eddy currents equipment: A case study
Study date
2022
Auth party contact address
-
Data no
273472
Title
FOREIGN OBJECT CONTAMINATION IN BEEF CATTLE
Study date
2002
Auth party contact address
-
Data no
273473
Title
Prevention of Needlestick Injuries in Livestock Production
Study date
2022
Auth party contact address
-
Data no
273474
Title
PREVENTING NEEDLESTICK INJURIES
Study date
2019
Auth party contact address
-
Data no
273475
Title
Occupational hazards reported by swine veterinarians in the United States
Study date
1996
Auth party contact address
-
Data no
273476
Title
Pork Chain Quality Audit
Study date
1994
Auth party contact address
-
Data no
273477
Title
Prevalence of carcass defects in sows at harvest
Study date
2009
Auth party contact address
-
Data no
273478
Title
Economic analysis of new workplace technology including productivity and injury: The case of needle-less injection in swine
Study date
2020
Auth party contact address
-
Data no
273479
Title
NAHEMS GUIDELINES: VACCINATION FOR CONTAGIOUS DISEASES
Study date
Oct 2014
Auth party contact address
-
Data no
273480
Title
Evaluation of a needle-free injection device to prevent hematogenous transmission of porcine reproductive and respiratory syndrome virus
Study date
2012
Auth party contact address
-
Data no
273481
Title
Needle-free injection technology in swine: Progress toward vaccine efficacy and pork quality
Study date
2008
Auth party contact address
-
Data no
273482
Title
Needle-Free Injection: Pros and Cons
Study date
2010
Auth party contact address
-
Data no
273483
Title
Current status and future prospects of needle-free liquid jet injectors
Study date
2006
Auth party contact address
-
Data no
273484
Title
IMMUNIZATION WITHOUT NEEDLES
Study date
2005
Auth party contact address
-
Data no
273485
Title
8 - General immunization practices
Study date
2013
Auth party contact address
-
Data no
273486
Title
Effect of needle size on immunogenicity and reactogenicity of vaccines in infants: randomised controlled trial
Study date
2006
Auth party contact address
-
Data no
273487
Title
Short-term Efficacy Study with RespiSure-One Administered with a Needle-free Device
Study date
2004
Auth party contact address
-
Data no
273488
Title
Intramuscular and Intradermal Vaccination of Swine for Swine Influenza Virus and Mycoplasma hyopneumoniae Using a Needle-Free Device
Study date
2002
Auth party contact address
-
Data no
273489
Title
Effectiveness of transdermal, needle-free injections for reducing pork carcass defects
Study date
2004
Auth party contact address
-
Data no
273490
Title
Field testing of a new needle-free, intramuscular injection device for pigs
Study date
2020
Auth party contact address
-
Data no
273491
Title
PULSE 200 EFFECTIVE APPLICATION METHOD FOR PRRS VACCINE IN GILTS
Study date
2003
Auth party contact address
-
Data no
273492
Title
A comparison of the efficacy of conventional and needle-free administration of Porcilis (R) APP as assessed by ELISA concentrations of antibody concentration to APX I, APX II, APX III and OMP
Study date
2006
Auth party contact address
-
Data no
273493
Title
Safety evaluation of a modified live pseudorabies virus vaccine administered using a needle-free, transdermal injection device
Study date
2003
Auth party contact address
-
Data no
273494
Title
Ph Eur Monograph 2448
Study date
2017
Auth party contact address
-
Data no
273495
Title
Clinical immunogenicity of measles, mumps and rubella vaccine delivered by the Injex jet injector: comparison with standard syringe injection
Study date
2000
Auth party contact address
-
Data no
273496
Title
Survey of Injection Methodologies and Carcass Defects in Pork Production NPB #07-219
Study date
2008
Auth party contact address
-
Data no
273497
Title
Boehringer Ingelheim partners with Henke-Sass, Wolf to develop innovative needle free injection device for pigs
Study date
2020
Auth party contact address
-
Data no
273498
Title
Pulse Needle Free Launches the Worlds First Disposable Needle-Free Injector for Livestock
Study date
2022
Auth party contact address
-
Data no
273499
Title
The AcuShot Gen 2 Advantage
Study date
2022
Auth party contact address
-
Data no
273500
Title
The IDAL Way, 20 Years and Counting
Study date
2022
Auth party contact address
-
Data no
273501
Title
Hipra: We are pleased to announce the launch of our new Hipradermic website!
Study date
2021
Auth party contact address
-
Data no
273502
Title
HUMAN LIVESTOCK INTERACTIONS, SECOND EDITION
Study date
2011
Auth party contact address
-
Data no
273503
Title
Heart rate variability and vocalization as a measure of stress response in pigs to needle-free injections versus needle and syringe
Study date
2010
Auth party contact address
-
Data no
273504
Title
Effect of the needle-free intra dermal application of liquids vaccination on the welfare of pregnant sows
Study date
2017
Auth party contact address
-
Data no
273505
Title
Efficacy and safety of needle-free transdermal delivery of a novel Mycoplasma hyopneumoniae bacterin
Study date
2006
Auth party contact address
-
Data no
273506
Title
Reduction in Lesion Incidence in Pork Carcass Using Transdermal Needle-free Injection of Foot-and- Mouth Disease Vaccine
Study date
2018
Auth party contact address
-
Data no
273507
Title
The first effective transdermal, needle-free injections in Canada
Study date
2005
Auth party contact address
-
Data no
273508
Title
Comparison of injection sites between needlefree injections and needle injections in swine
Study date
2005
Auth party contact address
-
Data no
273509
Title
Letter of Support 1
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273510
Title
Letter of Support 2
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273464
Title
B924N-ES-23-C32 Study report
Study date
Feb 2023
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273447
Title
Part 1 Application Overview
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273449
Title
RLP approved Fostera Gold PCV MH, 87927/134267
Study date
2022
Auth party contact address
-
Data no
273450
Title
RLP proposed Fostera Gold PCV MH, tracked changes
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273451
Title
RLP proposed Fostera Gold PCV MH, clean copy
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273452
Title
RLP approved Fostera Gold PCV Metastim, 88614/134268
Study date
2022
Auth party contact address
-
Data no
273453
Title
RLP proposed Fostera Gold PCV Metastim, tracked changes
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273454
Title
RLP proposed Fostera Gold PCV Metastim, clean copy
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
285223
Title
s159 Response
Study date
2025
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
285224
Title
Performance Report for Fostera Gold PCV MH
Study date
2024
Auth party contact address
LEVEL 6, 5 RIDER BOULEVARD RHODES Australia
Data no
273455
Title
Summary of opinion (post authorisation) CircoMax Myco
Study date
6 Oct 2023
Auth party contact address
-
Data no
273456
Title
CVMP assessment report for a worksharing variation requiring assessment for CircoMax and CircoMax Myco (EMEA/V/C/WS2429)
Study date
5 Oct 2023
Auth party contact address
-
Data no
273458
Title
SPC for CircoMax Myco emulsion for injection for pigs
Study date
2023
Auth party contact address
-
Data no
273459
Title
SPC for CircoMax emulsion for injection for pigs
Study date
2023
Auth party contact address
-
Date
Application Date
Application No
Application Number
144281
Product/Active constituent Name
Application Product Name
The Plant Runner Hormone Rooting Liquid
Application Date
Application Number
144281
Application Product Name
The Plant Runner Hormone Rooting Liquid
Application details
Product name:
The Plant Runner Hormone Rooting Liquid
Applicant Name:
THE PLANT RUNNER PTY LTD
Application purpose and description of use:
Registration of a 4 g/L Indole butyric acid liquid concentrate product used to strike and accelerate roots on most plant cuttings.
Date
Application Date
Application No
Application Number
144540
Product/Active constituent Name
Application Product Name
Take Control Conquer Moth Balls
Application Date
Application Number
144540
Application Product Name
Take Control Conquer Moth Balls
Application details
Product name:
Take Control Conquer Moth Balls
Product number:
95044
Applicant Name:
YATSAL DISTRIBUTORS PTY LTD
Application purpose and description of use:
Registration of a 990 g/kg naphthalene slow release generator product for household control of moths and silverfish.
Reference details:
90862 - Brunnings Moth Balls
Description of data provided:
Data no
273684
Title
Packaging example
Study date
June 2024
Auth party contact address
2A Murray Jones Drive BANKSTOWN AERODROME Australia
Date
Application Date
Application No
Application Number
144481
Product/Active constituent Name
Application Product Name
Thiamethoxam
Application Date
Application Number
144481
Application Product Name
Thiamethoxam
Application details
Product name:
Thiamethoxam
Active name:
Thiamethoxam
Applicant Name:
HEBEI DE RICK CHEMICAL CO., LTD
Application purpose and description of use:
Approval of Thiamethoxam technical grade material for use in agricultural chemical products.
Description of data provided:
Data no
273289
Title
Final report Preliminary Analysis and Enforcement Analytical Method of Thiamethoxam Technical
Study date
12/04/2024
Auth party contact address
No 1, Road No 1 New Industrial Zone Gaocheng District, Shijiazhuang China
Data no
273290
Title
Final report Confidential attachment Preliminary Analysis and Enforcement Analytical Method of Thiamethoxam Technical
Study date
12/04/2024
Auth party contact address
No 1, Road No 1 New Industrial Zone Gaocheng District, Shijiazhuang China
Data no
273291
Title
Declaration of Composition
Study date
14/05/2024
Auth party contact address
No 1, Road No 1 New Industrial Zone Gaocheng District, Shijiazhuang China
Data no
281795
Title
PRELIMINARY ANALYSES OF FIVE REPRESENTATIVE
PRODUCTION BATCHES OF THIAMETHOXAM
TECHNICAL GRADE TO QUANTIFY ITS DMF AND
1,2-DICHLOROETHANE
PRODUCTION BATCHES OF THIAMETHOXAM
TECHNICAL GRADE TO QUANTIFY ITS DMF AND
1,2-DICHLOROETHANE
Study date
06/11/2024
Auth party contact address
No 1, Road No 1 New Industrial Zone Gaocheng District, Shijiazhuang China
Data no
281796
Title
PART 2 CHEMISTRY & MANUFACTURE For approval of new source of Thiamethoxam technical constituent
Study date
11/2024
Auth party contact address
No 1, Road No 1 New Industrial Zone Gaocheng District, Shijiazhuang China
Data no
273292
Title
Chemistry & Manufacture For Approval of New Source of Thiamethoxam
Study date
07/05/2024
Auth party contact address
No 1, Road No 1 New Industrial Zone Gaocheng District, Shijiazhuang China
Data no
281797
Title
Explanation - Thiamethoxam TC
Study date
07/11/2024
Auth party contact address
No 1, Road No 1 New Industrial Zone Gaocheng District, Shijiazhuang China
Date
Application Date
Application No
Application Number
144696
Product/Active constituent Name
Application Product Name
Ilium Frusemide Injection
Application Date
Application Number
144696
Application Product Name
Ilium Frusemide Injection
Application details
Product name:
Ilium Frusemide Injection
Product number:
50268
Applicant Name:
TROY LABORATORIES PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to extend the storage shelf life and establish an in-use shelf for the product.
Active constituents:
Active constituent name
85900 - Furosemide
Description of data provided:
Data no
274302
Title
PRODUCT STABILITY REPORT
Study date
2018
Auth party contact address
37 GLENDENNING ROAD GLENDENNING Australia
Data no
274303
Title
IN-USE STABILITY REPORT
Study date
2018
Auth party contact address
37 GLENDENNING ROAD GLENDENNING Australia
Date
Application Date
Application No
Application Number
144750
Product/Active constituent Name
Application Product Name
APEX AMOXYCILLIN - 200 BROAD-SPECTRUM ANTIBIOTIC TABLETS
Application Date
Application Number
144750
Application Product Name
APEX AMOXYCILLIN - 200 BROAD-SPECTRUM ANTIBIOTIC TABLETS
Application details
Product name:
APEX AMOXYCILLIN - 200 BROAD-SPECTRUM ANTIBIOTIC TABLETS
Product number:
35698
Applicant Name:
DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.
Application purpose and description of use:
Variation of label approval to change the distinguishing product name and label name.
Active constituents:
Active constituent name
81892 - AMOXYCILLIN TRIHYDRATE
Date
Application Date
Application No
Application Number
144752
Product/Active constituent Name
Application Product Name
APEX AMOXYCILLIN - 400 BROAD-SPECTRUM ANTIBIOTIC TABLETS
Application Date
Application Number
144752
Application Product Name
APEX AMOXYCILLIN - 400 BROAD-SPECTRUM ANTIBIOTIC TABLETS
Application details
Product name:
APEX AMOXYCILLIN - 400 BROAD-SPECTRUM ANTIBIOTIC TABLETS
Product number:
35697
Applicant Name:
DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.
Application purpose and description of use:
Variation of label approval to change the distinguishing product and label name and to update the label per current VLC.
Active constituents:
Active constituent name
81892 - AMOXYCILLIN TRIHYDRATE
Date
Application Date
Application No
Application Number
144776
Product/Active constituent Name
Application Product Name
F.S.A. Vixin Herbicide
Application Date
Application Number
144776
Application Product Name
F.S.A. Vixin Herbicide
Application details
Product name:
F.S.A. Vixin Herbicide
Product number:
89965
Applicant Name:
FOUR SEASONS AGRIBUSINESS PTY LTD
Application purpose and description of use:
Variation of product registration to add available formulations.
Reference details:
69353 - CROP CARE INTERCEPT HERBICIDE
69353 - NUFARM INTERCEPT HERBICIDE
Active constituents:
Active constituent name
51086 - IMAZAMOX
Active constituent name
44308 - IMAZAPYR
Active constituent name
62015 - IMAZAPYR
Active constituent name
70374 - IMAZAMOX
Description of data provided:
Data no
274780
Title
Consent For Use of Confidential Commercial Information and Access to Information with Limits on Use
Study date
12 July 2024
Auth party contact address
287 Boorowa Street YOUNG Australia
Date
Application Date
Application No
Application Number
144775
Product/Active constituent Name
Application Product Name
Agro-Essence Carfentrazone 240 EC Herbicide
Application Date
Application Number
144775
Application Product Name
Agro-Essence Carfentrazone 240 EC Herbicide
Application details
Product name:
Agro-Essence Carfentrazone 240 EC Herbicide
Product number:
95135
Applicant Name:
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
Application purpose and description of use:
Registration of a Carfentrazone-Ethyl 240 g/l emulsifiable concentrate product for the Improvement in the Control of Marshmallow and Certain Other Broadleaf Weeds Prior to Establishment of Broadacre Crops, Fallows or Forest Plantations, in Commercial, Industrial and Public Service Areas, and Around Agricultural Buildings and Yards, in Treefruits, Nuts, Grapevines in Tank Mixture with Knockdown Herbicides; for the Control of Marshmallow and Annual Nettles in Grass Pastures and Rough Grass/Turf Areas; for the Control of Suckers in Raspberries, Blackberries, Currants, Gooseberries; and Control of Volunteer Cotton Seedlings Including Roundup Ready Cotton and Desiccation of Cotton Re-growth
Reference details:
70154 - GENFARM CARFENTRAZONE 240 EC HERBICIDE
Active constituents:
Active constituent name
68094 - CARFENTRAZONE-ETHYL
Date
Application Date
Application No
Application Number
144783
Product/Active constituent Name
Application Product Name
TITAN TEBUCONAZOLE 430 SC FUNGICIDE
Application Date
Application Number
144783
Application Product Name
TITAN TEBUCONAZOLE 430 SC FUNGICIDE
Application details
Product name:
TITAN TEBUCONAZOLE 430 SC FUNGICIDE
Product number:
61649
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to amend statements in the directions for use section of the label. These amendments do no change use patterns on the label
Active constituents:
Active constituent name
53896 - TEBUCONAZOLE
Date
Application Date
Application No
Application Number
144774
Product/Active constituent Name
Application Product Name
SAFLUFENACIL
Application Date
Application Number
144774
Application Product Name
SAFLUFENACIL
Application details
Product name:
SAFLUFENACIL
Active name:
SAFLUFENACIL
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of Saflufenacil for use in agricultural chemical products.
Description of data provided:
Data no
274783
Title
Analysis Method - Saflufenacil TC
Study date
2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
274785
Title
Five Batch Analysis of Saflufenacil Technical - Study No. 0650
Study date
08/01/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
274782
Title
Method of Manufacture - Saflufenacil Tech
Study date
20/02/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
274784
Title
Declaration of Composition (DoC) - Saflufenacil
Study date
22/03/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
274786
Title
Certificate of Analysis (CoA) - Saflufenacil Technical Commercial Batches
Study date
April 2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
274787
Title
MSDS for Saflufenacuil 97% TC
Study date
2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
274781
Title
PART 1 - EXECUTIVE SUMMARY; PART 2 - CHEMISTRY & MANUFACTURE SUMMARY
Study date
16/07/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
274788
Title
Letter of Support / Authorisation from Source - Saflufenacil Technical
Study date
22/03/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia