Application Summaries
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 browse function and links below to find and view application summaries.
Azoxystrobin
Application Date
03-Oct-2023
Application Number
141453
Application Date
03-Oct-2023Application Number
141453Application Details
Product name
AzoxystrobinActive name
AzoxystrobinApplicant name
AGOCEANIA PTY LTDApplication purpose and description of use
Approval of Azoxystrobin for use in agricultural chemical products.Description of data provided
Data no
259336Title
Manufacture Process of Azoxystrobin TechnicalStudy date
July 5, 2023Publication
NoData no
259339Title
The Justification of Impurities of Azoxystrobin TechnicalStudy date
July 5, 2023Publication
NoData no
259334Title
Five Batches Analysis of Azoxystrobin TCStudy date
January 11, 2016Publication
NoData no
259340Title
The statement of batch size of Azoxystrobin technical in 5-batch reportStudy date
July 5, 2023Publication
NoData no
259337Title
Physical and chemical properties of AzoxystrobinStudy date
July 5, 2023Publication
NoData no
259338Title
Registration Data of AzoxystrobinStudy date
July 5, 2023Publication
NoData no
259335Title
DoC of Azoxystrobin TCStudy date
July 5, 2023Publication
No
Farmozine 900 Herbicide
Application Date
03-Oct-2023
Application Number
141478
Application Date
03-Oct-2023Application Number
141478Application Details
Product name
Farmozine 900 HerbicideProduct no
93852Applicant name
ADAMA AUSTRALIA PTY LIMITEDApplication purpose and description of use
Variation of product registration and label approval to add an additional pack size and update the directions for use.Active constituents
Active constituent name
44367 - ATRAZINEDescription of data provided
Data no
259408Title
Executive SummaryStudy date
25 September 2023Publication
-Reference Details
TICKPRO DUO TICK DEVELOPMENT INHIBITOR AND BROAD SPECTRUM POUR-ON
Application Date
03-Oct-2023
Application Number
141476
Application Date
03-Oct-2023Application Number
141476Application Details
Product name
TICKPRO DUO TICK DEVELOPMENT INHIBITOR AND BROAD SPECTRUM POUR-ONProduct no
90905Applicant name
SPECIALIST SALES PTY LTDApplication purpose and description of use
Variation of product registration and label approval to vary relevant particulars.Active constituents
Active constituent name
82733 - IVERMECTINActive constituent name
82732 - FLUAZURON
Campbell Wrath 700WG Fungicide
Application Date
03-Oct-2023
Application Number
141477
Application Date
03-Oct-2023Application Number
141477Application Details
Product name
Campbell Wrath 700WG FungicideProduct no
82661Applicant name
COLIN CAMPBELL (CHEMICALS) PTY LTDApplication purpose and description of use
Variation of label approval to reduce the rate of use for control of downy mildew on grapevines.Active constituents
Active constituent name
69308 - DITHIANONActive constituent name
88181 - DithianonReference Details
MAXICAM ANTI-INFLAMMATORY INJECTABLE FOR DOGS AND CATS
Application Date
29-Sep-2023
Application Number
141463
Application Date
29-Sep-2023Application Number
141463Application Details
Product name
MAXICAM ANTI-INFLAMMATORY INJECTABLE FOR DOGS AND CATSProduct no
92420Applicant name
VETPHARM LABORATORIES IP PTY LTDApplication purpose and description of use
Variation of product registration and/or label approval to vary pack sizes.Active constituents
Active constituent name
84110 - Meloxicam
Gastrosyl Bismuth salicylate oral suspension
Application Date
29-Sep-2023
Application Number
141034
Application Date
29-Sep-2023Application Number
141034Application Details
Product name
Gastrosyl Bismuth salicylate oral suspensionProduct no
93950Applicant name
VETSENSE PTY LTDApplication purpose and description of use
Registration of a Bismuth Salicylate 17.5 mg/mL oral suspension, to be used as an aid in the treatment of gastroenteritis and diarrhoea in horses and dogs.Description of data provided
Data no
258440Title
Quality ControlStudy date
2022Publication
-Data no
258441Title
Finish Product SpecificationsStudy date
23 December 2021Publication
-Data no
258439Title
ManufacturingStudy date
2023Publication
-Reference Details
Glysmart 600 Herbicide
Application Date
29-Sep-2023
Application Number
141213
Application Date
29-Sep-2023Application Number
141213Application Details
Product name
Glysmart 600 HerbicideProduct no
94011Applicant name
GROW CHOICE PTY LTDApplication purpose and description of use
Registration of a 600 g/L formulation of glyphosate (as the potassium salt) - A non-selective herbicide for the control of many annual and perennial weedsActive constituents
Active constituent name
63383 - GLYPHOSATEActive constituent name
64304 - GLYPHOSATEDescription of data provided
Data no
258460Title
BIOEQUIVALENCE OF GLYSMART 600 WITH GLYMOUNT 540 FOR WEED CONTROL IN FALLOW GLYSMART600-BIOEQ- 2023-02Study date
16 May 2023Publication
-Data no
258454Title
C of A for activeStudy date
August 2023Publication
-Data no
258457Title
Executive SummaryStudy date
25 August 2023Publication
-Data no
258466Title
EVALUATION OF A K SALT FORMULATION OF GLYPHOSATE ALONE AND IN COMBINATION WITH VARIOUS SURFACTANTS FOR WEED CONTROL IN FALLOW GC-GC-GLY600-FALLOW-2022-01-02Study date
6 May 2023Publication
-Data no
258463Title
BIOEQUIVALENCE OF GLYSMART 600 +/- TERWETT 3780 AND GLYSOWET FOR FALLOW WEED CONTROL 14 May 2023 GLYSMART600-BIOEQ-TERWETT-2023_01Study date
14 May 2023Publication
-Data no
258455Title
Safety Data SheetsStudy date
August 2023Publication
-Data no
258467Title
BIOEQUIVALENCE OF GROW CHOICE GLYPHOSATE 600K, GLYSMART 600 AND ROUNDUP CT FOR PRE-HARVEST DRYDOWN OF GRAIN SORGHUM GC-GC-GLY600-SORG-PREHARV-2022-01-01Study date
6 May 2023Publication
-Data no
258458Title
Part 8 - EfficacyStudy date
June 2023Publication
-Data no
258464Title
EVALUATION OF A K SALT FORMULATION OF GLYPHOSATE ALONE AND IN COMBINATION WITH VARIOUS SURFACTANTS FOR WEED CONTROL IN FALLOW GC-GC-GLY600-FALLOW-2022-01-03Study date
6 May 2023Publication
-Data no
258461Title
BIOEQUIVALENCE OF GLYSMART 600 WITH GLYMOUNT 540 FOR WEED CONTROL IN FALLOW GLYSMART600-BIOEQ- 2023-03Study date
17 May 2023Publication
-Data no
258465Title
EVALUATION OF A K SALT FORMULATION OF GLYPHOSATE ALONE AND IN COMBINATION WITH VARIOUS SURFACTANTS FOR WEED CONTROL IN FALLOW GC-GC-GLY600-FALLOW-2022-01-01Study date
6 May 2023Publication
-Data no
258462Title
BIOEQUIVALENCE OF GLYSMART 600 +/- TERWET 3780 AND GLYSOWET FOR FALLOW WEED CONTROL GLYSMART600-BIOEQ-TERWETT-2023_2Study date
14 May 2023Publication
-Data no
258456Title
Determination of the Physical-chemical properties of Glyphosate 600 SL formulationStudy date
25 May 2023Publication
-Data no
258459Title
BIOEQUIVALENCE OF GLYSMART 600 WITH GLYMOUNT 540 FOR WEED CONTROL IN FALLOW Report No: GLYSMART600-BIOEQ- 2023-01Study date
15 May 2023Publication
-Data no
258453Title
Part 2 - Chemistry and ManufactureStudy date
August 2023Publication
-Reference Details
Kenso Agcare RAMPAGE EW Insecticide/Miticide
Application Date
29-Sep-2023
Application Number
141256
Application Date
29-Sep-2023Application Number
141256Application Details
Product name
Kenso Agcare RAMPAGE EW Insecticide/MiticideProduct no
94021Applicant name
KENSO CORPORATION (M) SDN. BHD.Application purpose and description of use
Registration of a Chlorpyrifos 400 g/L and Bifenthrin 20 g/L EW product for the control of certain insect pests of broadacre crops, cotton and other various crops as specified in the Directions for Use table.Active constituents
Active constituent name
67331 - CHLORPYRIFOSActive constituent name
59942 - BIFENTHRINDescription of data provided
Data no
258772Title
Part 2 Chemistry and Manufacture dossier of RAMPAGE EWStudy date
28/8/2023Publication
-Data no
258778Title
Appendix 8.1 The efficacy of insecticides at controlling red legged earth mites in canolaStudy date
Sep 2017Publication
-Data no
258775Title
2 3 Stability Report of Kenso Agcare RAMPAGE EW Insecticide/MiticideStudy date
20/11/2022Publication
-Data no
258776Title
2 4 Analytical Method of Rampage EW by GCStudy date
24/11/2022Publication
-Data no
258779Title
Appendix 8.2 The efficacy of a range of insecticides at controlling red legged earth mites in wheatStudy date
Sep 2017Publication
-Data no
258773Title
2 1 Certificate of Analysis of Active ConstituentsStudy date
2022Publication
-Data no
258774Title
2 2 SDS of Inert IngredientsStudy date
28/8/2023Publication
-Data no
258777Title
Part 8 Efficacy and Crop Safety of RAMPAGE EWStudy date
28/8/2023Publication
-Reference Details
Surefire Chlorantraniliprole 350 WG Insecticide
Application Date
29-Sep-2023
Application Number
141288
Application Date
29-Sep-2023Application Number
141288Application Details
Product name
Surefire Chlorantraniliprole 350 WG InsecticideProduct no
88598Applicant name
PCT HOLDINGS PTY LTDApplication purpose and description of use
Variation of product registration and label approval to add use for control of carob moth in almond crops. ÂActive constituents
Active constituent name
86178 - CHLORANTRANILIPROLEDescription of data provided
Data no
258543Title
Part 8 SummaryStudy date
August 2023Publication
-Data no
258541Title
Evaluation of PCT International Surefire Chlorantraniliprole for the control Carob Moth (Ectomyelois ceratoniae) in Almonds.Study date
23/06/2022Publication
-Data no
258542Title
Altacor Hort Insecticide 69957/109980Study date
14/08/2018Publication
-Auth party contact address
-
bismuth subsalicylate
Application Date
29-Sep-2023
Application Number
141313
Application Date
29-Sep-2023Application Number
141313Application Details
Product name
bismuth subsalicylateActive name
bismuth subsalicylateApplicant name
VETSENSE PTY LTDApplication purpose and description of use
New source of pharmacopoeia active constituent.Description of data provided
Data no
258719Title
CoA - APIStudy date
2021Publication
-
IMTRADE SENTINEL 800 VERIPHY SL INSECTICIDE
Application Date
29-Sep-2023
Application Number
141452
Application Date
29-Sep-2023Application Number
141452Application Details
Product name
IMTRADE SENTINEL 800 VERIPHY SL INSECTICIDEProduct no
94076Applicant name
IMTRADE AUSTRALIA PTY LTDApplication purpose and description of use
Registration of a 800g/L OMETHOATE soluble liquid product for the control of certain pests on Ornamentals as specified in the Directions for Use table.Active constituents
Active constituent name
59132 - OMETHOATEDescription of data provided
Data no
259333Title
Imtrade Sentinel 800 VeripHy SL Insecticide Formulation & Supporting InfoStudy date
20/09/2023Publication
-Reference Details
Sugar beet
Application Date
28-Sep-2023
Application Number
141351
Application Date
28-Sep-2023Application Number
141351Application Details
Product name
Sugar beetProduct no
94051Applicant name
ADAMA AUSTRALIA PTY LIMITEDApplication purpose and description of use
Registration of a 900 g/L Beet Extract product that is a natural elicitor that enhances the plant defences in Vine grapes increasing their resistance to Botrytis infection in conjunction with approval of Beet Extract active constituent..Description of data provided
Data no
259227Title
Analysis report 23003358-01-1 beet extract. Acylamide and hydroxymethylfurfural. Report no. 23003358-01-1Study date
17 July 2023.Publication
-Data no
259204Title
Sample overview: Sugar beet extract (raw ingredient). Waikaitu Ltd., Tasman, New Zealand, 16 February 2022Study date
16 February 2022Publication
-Data no
259210Title
Certificate of Analysis. Cawthron Analytical Science, Nelson, New Zealand; report no. 941026Study date
2 May 2022Publication
-Data no
259218Title
Two batch analysis of trimethylglycine in beet extract samples. Report no. S22- 06525, ADAMA file report 000111862Study date
16 September 2022.Publication
-Data no
259230Title
ADS-43. Document M-CP, Section 5. Analytical Methods.Study date
July 2023.Publication
-Data no
259207Title
Compendium of botanicals reported to contain naturally occurring substances of possible concern for human health when used in food and feed supplements. Scientific Report 2663,Study date
2012Publication
EFSA Journal 2012;10(5)Auth party contact address
-Data no
259201Title
QSAR estimation of vapour pressure, partition coefficient, and Henry??s law constant by using the EPISuite model version 4.11.Study date
11 August 2022Publication
-Data no
259224Title
Analysis report 22006105-02-1 beet extract. Tropane alkaloids. Report no. 22006105-01-2Study date
7 November 2022.Publication
-Data no
259221Title
Certificate of Accreditation. Cawthron Institute, Accreditation no. 107, 12 May 2022Study date
12 May 2022Publication
-Data no
259198Title
Determination Of Active Content & Physical Characteristics of Beet Extract in HDPE Containers Following Accelerated Storage For Two Weeks At 54 ??C. Report No. S22-0328.Study date
21 March 2023.Publication
-Data no
259202Title
Consensus document on compositional considerations for new varieties of sugar beet: Key food and feed nutrients and antinutrients. Series on the Safety of Novel Foods and Feeds, No. 3 OECD Environmental Directorate,Study date
2002Publication
ENV/JM/MONO(2002)4Auth party contact address
-Data no
259225Title
Analysis report 22006106-03-1 beet extract. Hydroxymethylfurfural HMF. Report no. 22006106-03-1Study date
15 November 2022.Publication
-Data no
259216Title
Certificate of Analysis. Amended. Cawthron Analytical Science, NelsonStudy date
7 July 2023.Publication
-Data no
259222Title
Akkreditierung Deutsche Akkreditierungsstelle GmbH. Institut Kurz GmbH. Certificate no. D-PL-14140-01-00Study date
14 December 2021Publication
-Data no
259199Title
HANDBOOK OF Aqueous Solubility Data. SECOND EDITION. 2010 CEC Pres Taylor & Francis Group.Study date
2010Publication
HANDBOOK OF Aqueous Solubility Data. SECOND EDITION. 2010 CEC Pres Taylor & Francis Group.Auth party contact address
-Data no
259205Title
Sample overview part 2: Sugar beet extract (raw ingredient) Waikaitu Ltd., Tasman, New Zealand,Study date
19 December 2022Publication
-Data no
259213Title
Certificate of Analysis Cawthron Analytical Science, Nelson, New Zealand, report no. 938445Study date
27 April 2022.Publication
-Data no
259219Title
Analysis of trimethylglycine in two batches of beet extract. Report no. S23- 101874, ADAMA file report 00011Study date
30 May 2023.Publication
-Data no
259208Title
Certificate of Analysis Cawthron Analytical Science, Nelson, New Zealand, report no. 921895Study date
12 January 2022Publication
-Data no
259214Title
Certificate of Analysis Cawthron Analytical Science, Nelson, New Zealand, report no. 976076Study date
21 December 2021.Publication
-Data no
259220Title
Analysis report 22006103-02-1 beet extract. Chemical results free amino acids. Report no. 22006103-02Study date
2 November 2022.Publication
-Data no
259228Title
Analysis of the Composition Fingerprint of Four Batches of Beet Extract. Report No. S23-104968Study date
27 July 2023Publication
-Data no
259211Title
Certificate of Analysis. Cawthron Analytical Science, Nelson, New Zealand; report no. 864603Study date
26 Jan 2021Publication
-Data no
259217Title
Method validation and batch analysis of trimethylglycine in beet extract and ADS-43 formulated product samples. report no. S21- 09099, ADAMA file report 000109781Study date
12 May 2022Publication
-Data no
259200Title
Dioxins and furans content in 1` batch of beet extract. Report No. AR-22-NC-009555-01.Study date
27 April 2022.Publication
-Data no
259229Title
Methodology information. Amended letter. Report no. 1426BStudy date
26 June 2023Publication
-Data no
259206Title
Non-GMO Certificate R141703 Results of inspection.Study date
28 August 2017Publication
-Data no
259212Title
Statement on internal and external molasses labelling. Identification BT210122.Study date
6 March 2022Publication
-Data no
259203Title
Russian Federation. Sugar sector review. FAO Investment Centre, Rome 2013Study date
2013Publication
Food and agriculture organization oF the united nations rome, 2013Auth party contact address
-Data no
259226Title
Analysis Pyrrolizidine Tropane alkaloids. Report 23003358-02-2Study date
29 July 2023.Publication
-Data no
259209Title
Analysis of sugar beet molasses. Statement identification number GB201016-19Study date
20 April 2022Publication
-Data no
259215Title
Certificate of Analysis Cawthron Analytical Science, Nelson, New Zealand, report no. 989894Study date
30 March 2023Publication
-Data no
259223Title
Analysis report 22006104-02-1 beet extract. Pyrrolizidine alkaloids. report no. 22006104-01-2Study date
7 November 2022.Publication
-
Nufarm Weedmaster DUO Herbicide
Application Date
28-Sep-2023
Application Number
141445
Application Date
28-Sep-2023Application Number
141445Application Details
Product name
Nufarm Weedmaster DUO HerbicideProduct no
53576Applicant name
NUFARM AUSTRALIA LIMITEDApplication purpose and description of use
Variation of product registration and label approval to allow marker dyes to be used and various minor label updates.Active constituents
Active constituent name
44453 - GLYPHOSATEActive constituent name
55368 - GLYPHOSATEActive constituent name
55695 - GLYPHOSATEActive constituent name
44279 - GLYPHOSATEActive constituent name
56452 - GLYPHOSATEActive constituent name
44042 - GLYPHOSATEActive constituent name
44040 - GLYPHOSATEActive constituent name
44041 - GLYPHOSATEDescription of data provided
Data no
259344Title
Draft Label - Marked UpStudy date
Sep 2023Publication
-Data no
259345Title
Draft Label - CleanStudy date
Sep 2023Publication
-Data no
259343Title
Executive SummaryStudy date
Sep 2023Publication
-
Azoxystrobin Technical
Application Date
28-Sep-2023
Application Number
141454
Application Date
28-Sep-2023Application Number
141454Application Details
Product name
Azoxystrobin TechnicalActive name
Azoxystrobin TechnicalApplicant name
HEMANI AUSTRALIA PTY LTDApplication purpose and description of use
Approval of Azoxystrobin for use in agricultural chemical products.Description of data provided
Data no
259367Title
Azoxystrobin AC Part 2 Chemistry and Manufacture - Hemani, IndiaStudy date
15.09.2023Publication
-Data no
259370Title
Appendix 2.3 - Azoxystrobin TC-Batch Size DetailsStudy date
15.09.2023Publication
-Data no
259371Title
Appendix 2.4 - GLP 5 batch _AG-G0668_FRStudy date
03.03.2023Publication
-Data no
259368Title
Appendix 2.1 Manufacuring Process Azoxystronin Technical, Hemani, IndiaStudy date
15.09.2023Publication
-Data no
259369Title
Appendix 2.2 - DECLARATION_OF_COMPOSITION_-_Azoxystrobin TC__HemaniStudy date
15.09.2023Publication
-
Chlorfenapyr Technical
Application Date
28-Sep-2023
Application Number
141455
Application Date
28-Sep-2023Application Number
141455Application Details
Product name
Chlorfenapyr TechnicalActive name
Chlorfenapyr TechnicalApplicant name
Shandong Rainbow International Co LtdApplication purpose and description of use
Approval of Chlorfenapyr Technical Technical for use in agricultural chemical products.Description of data provided
Data no
259350Title
Analysis of Five Batches of Chlorfenapyr Technical Material to determine the content of the active ingredient and specified impurities, in compliance with Good Laboratory Practice -Part 3Study date
20/07/2020Publication
-Data no
259347Title
Analysis of Five Batches of Chlorfenapyr Technical Material to determine the content of the active ingredient and specified impurities, in compliance with Good Laboratory Practice.- Part 1Study date
20/07/2020Publication
-Data no
259353Title
DOCStudy date
2023Publication
-Data no
259348Title
Analysis of Five Batches of Chlorfenapyr Technical Material to determine the content of the active ingredient and specified impurities, in compliance with Good Laboratory Practice -Part 2Study date
20/07/2020Publication
-Data no
259351Title
MANUFACTURE PROCESS OF CHLORFENAPYR TECHNICALStudy date
2023Publication
-Data no
259346Title
Chemistry &Manufacturing DossierStudy date
18/07/2023Publication
-Data no
259354Title
The Statement of Batch Size of Propamocarb CHLORFENAPYR TECHNICAL in 5-Batch ReportStudy date
2023Publication
-Data no
259352Title
THE JUSTIFICATION OF IMPURITIES OF CHLORFENAPYR TECHNICALStudy date
2023Publication
-Data no
259349Title
Analysis of Five Batches of Chlorfenapyr Technical Material to determine the content of the active ingredient and specified impurities, in compliance with Good Laboratory Practice -Part 3Study date
20/07/2020Publication
-Data no
259355Title
-Study date
2023Publication
-
NexGard Spectra Chewables for Dogs 2 - 3.5 kg
Application Date
28-Sep-2023
Application Number
141437
Application Date
28-Sep-2023Application Number
141437Application Details
Product name
NexGard Spectra Chewables for Dogs 2 - 3.5 kgProduct no
81008Applicant name
Boehringer Ingelheim Animal Health Australia Pty. Ltd.Application purpose and description of use
Variation of product label approval to lower the minimum bodyweight of dogs treated with this product.Active constituents
Active constituent name
82206 - Milbemycin oximeActive constituent name
81625 - AFOXOLANERDescription of data provided
Data no
259187Title
PRD 0230701 - Target Animal Safety StudyStudy date
2011Publication
-Data no
259184Title
Appendix 1 - PRD 0251101Study date
2023Publication
-Data no
259190Title
PRD 0355201 - Target Animal Safety StudyStudy date
2022Publication
-Data no
259193Title
Disposition of Ivermectin and Cyclosporin A in CF-1 Mice Deficient in MDR1A P-GlycoproteinStudy date
1999Publication
-Auth party contact address
-Data no
259185Title
PRD 0234001 - Target Animal Safety StudyStudy date
2012Publication
-Data no
259182Title
Executive SummaryStudy date
2023Publication
-Data no
259196Title
Safety of Oral Afoxolaner Formulated with or without Milbemycin Oxime in Homozygous MDR1-Deficient Collie DogsStudy date
2022Publication
-Auth party contact address
-Data no
259197Title
EMA CVMP Positive Opinion and Assessment ReportStudy date
2023Publication
-Data no
259191Title
Appendix 4 - PRD 0355201Study date
2023Publication
-Data no
259194Title
Canine ABCB1 and Macrocyclic Lactones: Heartworm Prevention and PharmacogeneticsStudy date
2008Publication
-Auth party contact address
-Data no
259188Title
Appendix 3 - PRD 0230701Study date
2023Publication
-Data no
259183Title
PRD 0251101 - Target Animal Safety StudyStudy date
2013Publication
-Data no
259195Title
Assessment of Toxicosis Induced by High-Dose Administration of Milbemycin Oxime in ColliesStudy date
1991Publication
-Auth party contact address
-Data no
259189Title
PRD 0215801 - Target Animal Safety StudyStudy date
2010Publication
-Data no
259186Title
Appendix 2 - PRD 0234001Study date
2023Publication
-Data no
259192Title
Interceptor Plus Product LabelStudy date
2023Publication
-Auth party contact address
-
CropSure Prozide 500SC Herbicide
Application Date
28-Sep-2023
Application Number
141444
Application Date
28-Sep-2023Application Number
141444Application Details
Product name
CropSure Prozide 500SC HerbicideProduct no
90212Applicant name
CROPSURE PTY LTDApplication purpose and description of use
Variation of label approval to match Rustler Selective Herbicide (61360) and F.S.A. Propyzamide 500 SC Herbicide (87920) labels to include Pulse and Canola crops.Active constituents
Active constituent name
65202 - PROPYZAMIDEDescription of data provided
Data no
259311Title
Scientific ArgumentStudy date
August 2023Publication
-Reference Details
Conquest Pinoxaden 100 EC Herbicide
Application Date
27-Sep-2023
Application Number
141430
Application Date
27-Sep-2023Application Number
141430Application Details
Product name
Conquest Pinoxaden 100 EC HerbicideApplicant name
CONQUEST CROP PROTECTION PTY LTDApplication purpose and description of use
Registration of a 100 g/L PINOXADEN and 25 g/L CLOQUINTOCET-MEXYL emulsifiable concentrate (EC) product forthe control of key grass weeds and selective spray topping of Wild Oats in Wheat and Barley
Conquest Hatchet Extra Herbicide EC
Application Date
27-Sep-2023
Application Number
141432
Application Date
27-Sep-2023Application Number
141432Application Details
Product name
Conquest Hatchet Extra Herbicide ECApplicant name
CONQUEST CROP PROTECTION PTY LTDApplication purpose and description of use
Registration of a 8 g/L Aminopyralid and 100 g/L Picloram and 300 g/L Triclopyr for control of a range of environmental and noxious woody and herbaceous weeds as specified in the Directions for Use table.
ANTAGONIST PRO RESIDUAL INSECTICIDE
Application Date
27-Sep-2023
Application Number
141439
Application Date
27-Sep-2023Application Number
141439Application Details
Product name
ANTAGONIST PRO RESIDUAL INSECTICIDEProduct no
67858Applicant name
SUNDEW SOLUTIONS PTY LTDApplication purpose and description of use
Variation of label approval to extend the list of situations for control of some ants. To extend pack size range.Description of data provided
Data no
259253Title
Reason for applicationStudy date
19 September 2023Publication
-Data no
259252Title
67858 AA letterStudy date
19 September 2023Publication
-Reference Details
TIAMULABS TIAMULIN SOLUBLE POWDER
Application Date
27-Sep-2023
Application Number
141416
Application Date
27-Sep-2023Application Number
141416Application Details
Product name
TIAMULABS TIAMULIN SOLUBLE POWDERProduct no
68980Applicant name
ABBEY LABORATORIES PTY LTDApplication purpose and description of use
Variation of product label approval to align the label with the current Vet Labelling CodeActive constituents
Active constituent name
82709 - TIAMULIN HYDROGEN FUMARATEActive constituent name
84120 - TIAMULIN HYDROGEN FUMARATE
ABBEYMOX FG FEED GRADE AMOXYCILLIN SOLUBLE POWDER
Application Date
26-Sep-2023
Application Number
141148
Application Date
26-Sep-2023Application Number
141148Application Details
Product name
ABBEYMOX FG FEED GRADE AMOXYCILLIN SOLUBLE POWDERProduct no
68888Applicant name
ABBEY LABORATORIES PTY LTDApplication purpose and description of use
Variation of product label approval to align the label with the current Vet Labelling Code.Active constituents
Active constituent name
67784 - ABBEYMOX AMOXYCILLIN SOLUBLE POWDERActive constituent name
82926 - AMOXYCILLIN TRIHYDRATEActive constituent name
84057 - AMOXICILLIN TRIHYDRATEActive constituent name
84262 - AMOXICILLIN TRIHYDRATE
Nufarm EvenBloom Plant Growth Regulator
Application Date
26-Sep-2023
Application Number
141363
Application Date
26-Sep-2023Application Number
141363Application Details
Product name
Nufarm EvenBloom Plant Growth RegulatorProduct no
94056Applicant name
NUFARM AUSTRALIA LIMITEDApplication purpose and description of use
Registration of a 530 g/L Cyanamide (Soluble Concentrate) product for the regulation of bud break in a range of crops.Active constituents
Active constituent name
63406 - CYANAMIDEReference Details
Glyphosate-isopropylammonium Manufacturing Concentrate
Application Date
26-Sep-2023
Application Number
141400
Application Date
26-Sep-2023Application Number
141400Application Details
Product name
Glyphosate-isopropylammonium Manufacturing ConcentrateActive name
Glyphosate-isopropylammonium Manufacturing ConcentrateApplicant name
Hubei Trisun Chemicals Co, LtdApplication purpose and description of use
Approval of Glyphosate-isopropylammonium Manufacturing Concentrate for use in agricultural chemical products.Description of data provided
Data no
259236Title
Glyphosate-isopropylammonium Manufacturing ConcentrateStudy date
14 September 2023Publication
Not PublishedData no
259233Title
Formation Of Impurities Glyphosate IPA Salt 62% Technical GradeStudy date
3 August 2023Publication
Not PublishedData no
259231Title
Executive SummaryStudy date
August 2023Publication
Not PublishedData no
259234Title
Declaration Of CompositionStudy date
31 July 2023Publication
Not PublishedData no
259232Title
The Formulation Process For Glyphosate IPA TechnicalStudy date
6 June 2023Publication
Not PublishedData no
259235Title
Preliminary Analysis and Enforcement Analytical Method of Glyphosate IPA Salt 62% W/W ??? Validation of Analytical Methodology for the Assay of Active Ingredient, Impurities, and Subsequent 5-Batch Analysis of Glyphosate IPA Salt 62% W/WStudy date
9 November 2021Publication
Not Published
BRAVECTO 1000 MG FLURALANER SPOT-ON SOLUTION FOR LARGE DOGS
Application Date
26-Sep-2023
Application Number
141419
Application Date
26-Sep-2023Application Number
141419Application Details
Product name
BRAVECTO 1000 MG FLURALANER SPOT-ON SOLUTION FOR LARGE DOGSProduct no
82794Applicant name
INTERVET AUSTRALIA PTY LIMITEDApplication purpose and description of use
Variation of product label approval.Active constituents
Active constituent name
80697 - FLURALANERDescription of data provided
Data no
259007Title
Notification LetterStudy date
June 2023Publication
-
BRAVECTO 1400 MG FLURALANER SPOT-ON SOLUTION FOR VERY LARGE DOGS
Application Date
26-Sep-2023
Application Number
141420
Application Date
26-Sep-2023Application Number
141420Application Details
Product name
BRAVECTO 1400 MG FLURALANER SPOT-ON SOLUTION FOR VERY LARGE DOGSProduct no
82795Applicant name
INTERVET AUSTRALIA PTY LIMITEDApplication purpose and description of use
Variation of product label approval.Active constituents
Active constituent name
80697 - FLURALANERDescription of data provided
Data no
259008Title
Notification LetterStudy date
June 2023Publication
-
BRAVECTO 500 MG FLURALANER SPOT-ON SOLUTION FOR MEDIUM DOGS
Application Date
26-Sep-2023
Application Number
141421
Application Date
26-Sep-2023Application Number
141421Application Details
Product name
BRAVECTO 500 MG FLURALANER SPOT-ON SOLUTION FOR MEDIUM DOGSProduct no
82796Applicant name
INTERVET AUSTRALIA PTY LIMITEDApplication purpose and description of use
Variation of product label approval.Active constituents
Active constituent name
80697 - FLURALANERDescription of data provided
Data no
259009Title
Notification LetterStudy date
June 2023Publication
-
BRAVECTO 250 MG FLURALANER SPOT-ON SOLUTION FOR SMALL DOGS
Application Date
26-Sep-2023
Application Number
141422
Application Date
26-Sep-2023Application Number
141422Application Details
Product name
BRAVECTO 250 MG FLURALANER SPOT-ON SOLUTION FOR SMALL DOGSProduct no
82797Applicant name
INTERVET AUSTRALIA PTY LIMITEDApplication purpose and description of use
Variation of product label approval.Active constituents
Active constituent name
80697 - FLURALANERDescription of data provided
Data no
259010Title
Notification LetterStudy date
June 2023Publication
-
BRAVECTO 112.5 MG FLURALANER SPOT-ON SOLUTION FOR VERY SMALL DOGS
Application Date
26-Sep-2023
Application Number
141423
Application Date
26-Sep-2023Application Number
141423Application Details
Product name
BRAVECTO 112.5 MG FLURALANER SPOT-ON SOLUTION FOR VERY SMALL DOGSProduct no
82798Applicant name
INTERVET AUSTRALIA PTY LIMITEDApplication purpose and description of use
Variation of product label approval.Active constituents
Active constituent name
80697 - FLURALANERDescription of data provided
Data no
259011Title
Notification LetterStudy date
June 2023Publication
-
EASIFLEX JOINT HEALTH POWDER FOR HORSES
Application Date
25-Sep-2023
Application Number
141412
Application Date
25-Sep-2023Application Number
141412Application Details
Product name
EASIFLEX JOINT HEALTH POWDER FOR HORSESProduct no
69644Applicant name
ABBEY LABORATORIES PTY LTDApplication purpose and description of use
Variation to align Current Vet labelling CodeActive constituents
Active constituent name
84174 - GLUCOSAMINE HYDROCHLORIDE
Glufosinate-Ammonium
Application Date
25-Sep-2023
Application Number
141153
Application Date
25-Sep-2023Application Number
141153Application Details
Product name
Glufosinate-AmmoniumActive name
Glufosinate-AmmoniumApplicant name
BASF AUSTRALIA LTD.Application purpose and description of use
Approval of Glufosinate-Ammonium for use in agricultural chemical products.Description of data provided
Data no
257768Title
DoC -TK50Study date
20/12/2022Publication
-Auth party contact address
LEVEL 12, 28 FRESHWATER PLACE SOUTHBANK Australia
Glufosinate-Ammonium
Application Date
25-Sep-2023
Application Number
141156
Application Date
25-Sep-2023Application Number
141156Application Details
Product name
Glufosinate-AmmoniumActive name
Glufosinate-AmmoniumApplicant name
BASF AUSTRALIA LTD.Application purpose and description of use
Approval of Glufosinate-Ammonium for use in agricultural chemical productsDescription of data provided
Data no
257785Title
DoC - TK50Study date
31/01/2023Publication
-
Glufosinate-Ammonium
Application Date
25-Sep-2023
Application Number
141157
Application Date
25-Sep-2023Application Number
141157Application Details
Product name
Glufosinate-AmmoniumActive name
Glufosinate-AmmoniumApplicant name
BASF AUSTRALIA LTD.Application purpose and description of use
Approval of Glufosinate-Ammonium for use in agricultural chemical productsDescription of data provided
Data no
257791Title
DoC - TK50Study date
21/12/2022Publication
-
FLUOPYRAM
Application Date
22-Sep-2023
Application Number
141145
Application Date
22-Sep-2023Application Number
141145Application Details
Product name
FLUOPYRAMActive name
FLUOPYRAMApplicant name
Qilu SYNVA Pharmaceutical Co., Ltd.Application purpose and description of use
Approval of Fluopyram for use in agricultural chemical products.Description of data provided
Data no
257790Title
StatementStudy date
August 2023Publication
-Data no
257787Title
Manufacturing Process of Fluopyram TCStudy date
August 2023Publication
-Data no
257788Title
Specification for Fluopyram TCStudy date
August 2023Publication
-Data no
257786Title
Determination of the active content and impurity profile of FluopyramStudy date
August 2023Publication
-Data no
257789Title
Declaration of compositionStudy date
August 2023Publication
-
Lincomycin Hydrochloride
Application Date
22-Sep-2023
Application Number
141122
Application Date
22-Sep-2023Application Number
141122Application Details
Product name
Lincomycin HydrochlorideActive name
Lincomycin HydrochlorideApplicant name
ZOETIS AUSTRALIA PTY LTDApplication purpose and description of use
Approval of active for use in veterinary chemical products.Description of data provided
Data no
257678Title
Certificate of AnalysisStudy date
30/4/2020Publication
n/aData no
257676Title
Certificate of AnalysisStudy date
30/4/2020Publication
n/aData no
257677Title
Certificate of AnalysisStudy date
29/4/2020Publication
n/a
Fluazuron
Application Date
22-Sep-2023
Application Number
141348
Application Date
22-Sep-2023Application Number
141348Application Details
Product name
FluazuronActive name
FluazuronApplicant name
ABBEY LABORATORIES PTY LTDApplication purpose and description of use
The Purpose of this application is to register active Fluazuron for use in our veterinary chemical productsDescription of data provided
Data no
258827Title
Flurazon V2 Part 1 of 2 dossierStudy date
SEP 23Publication
FluazuronV2 Part1 of 2.pdf;23371547Data no
258828Title
Flurazon V2 Part 2 of 2 dossierStudy date
SEP 23Publication
FluazuronV2 Part 2 of 2.pdf;32589464
F.S.A. Pyroxasulfone 850 WG Herbicide
Application Date
22-Sep-2023
Application Number
141355
Application Date
22-Sep-2023Application Number
141355Application Details
Product name
F.S.A. Pyroxasulfone 850 WG HerbicideProduct no
92777Applicant name
FOUR SEASONS AGRIBUSINESS PTY LTDApplication purpose and description of use
Variation of product registration to add a formulation.Active constituents
Active constituent name
64067 - PYROXASULFONEActive constituent name
91671 - PYROXASULFONEDescription of data provided
Data no
258864Title
Support for FSA - formulationStudy date
September 2023Publication
-Data no
258865Title
Access to CCI and Protected dataStudy date
September 2023Publication
-Reference Details
CLOMICALM 5 TABLETS FOR DOGS AND CATS
Application Date
22-Sep-2023
Application Number
141373
Application Date
22-Sep-2023Application Number
141373Application Details
Product name
CLOMICALM 5 TABLETS FOR DOGS AND CATSProduct no
50183Applicant name
VIRBAC (AUSTRALIA) PTY LTDApplication purpose and description of use
Variation of product registration to add an overseas site of manufacture.Active constituents
Active constituent name
54897 - CLOMIPRAMINE HYDROCHLORIDEActive constituent name
86769 - CLOMIPRAMINE HYDROCHLORIDEDescription of data provided
Data no
258915Title
GMP certificateStudy date
Jan 2023Publication
-Data no
258916Title
Application for modificationStudy date
Aug 2023Publication
n/aData no
258914Title
Cover letter - Clomicalm 5 variationStudy date
Sep 2023Publication
n/a
CLOMICALM 20 TABLETS FOR DOGS
Application Date
22-Sep-2023
Application Number
141374
Application Date
22-Sep-2023Application Number
141374Application Details
Product name
CLOMICALM 20 TABLETS FOR DOGSProduct no
50184Applicant name
VIRBAC (AUSTRALIA) PTY LTDApplication purpose and description of use
Variation of product registration to add an overseas site of manufacture.Active constituents
Active constituent name
54897 - CLOMIPRAMINE HYDROCHLORIDEActive constituent name
86769 - CLOMIPRAMINE HYDROCHLORIDEDescription of data provided
Data no
258918Title
GMP certificateStudy date
Jan 2023Publication
-Data no
258919Title
Application for modificationStudy date
Aug 2023Publication
n/aData no
258917Title
Cover letter - Clomicalm 20 variationStudy date
Sep 2023Publication
n/a
CLOMICALM 80 TABLETS FOR DOGS
Application Date
22-Sep-2023
Application Number
141386
Application Date
22-Sep-2023Application Number
141386Application Details
Product name
CLOMICALM 80 TABLETS FOR DOGSProduct no
50185Applicant name
VIRBAC (AUSTRALIA) PTY LTDApplication purpose and description of use
Variation of product registration to add an overseas site of manufacture.Active constituents
Active constituent name
54897 - CLOMIPRAMINE HYDROCHLORIDEActive constituent name
86769 - CLOMIPRAMINE HYDROCHLORIDEDescription of data provided
Data no
258921Title
Cover letter - Clomicalm 80 variationStudy date
Sep 2023Publication
n/aData no
258922Title
GMP certificateStudy date
Jan 2023Publication
-Data no
258923Title
Application for modificationStudy date
Aug 2023Publication
n/a
CAMPBELL CHEERS 720 FLOWABLE FUNGICIDE
Application Date
22-Sep-2023
Application Number
141393
Application Date
22-Sep-2023Application Number
141393Application Details
Product name
CAMPBELL CHEERS 720 FLOWABLE FUNGICIDEProduct no
56005Applicant name
COLIN CAMPBELL (CHEMICALS) PTY LTDApplication purpose and description of use
Variation of label approval to update Directions for UseActive constituents
Active constituent name
44206 - CHLOROTHALONILReference Details
Molidustat
Application Date
22-Sep-2023
Application Number
140895
Application Date
22-Sep-2023Application Number
140895Application Details
Product name
MolidustatProduct no
93913Applicant name
ELANCO AUSTRALASIA PTY LTDApplication purpose and description of use
This application is to apply for the registration of Varenzin oral suspension for cats which contains 25 mg/mL ofmolidustat. Approval of the API will be undertaken concurrently with this application.
The proposed indication is for the treatment of anaemia associated with Chronic Kidney Disease (CKD) in cats.
Varenzin Oral Solution for Cats
Application Date
22-Sep-2023
Application Number
140896
Application Date
22-Sep-2023Application Number
140896Application Details
Product name
Varenzin Oral Solution for CatsProduct no
93914Applicant name
ELANCO AUSTRALASIA PTY LTDApplication purpose and description of use
This application is to apply for the registration of Varenzin oral suspension for cats which contains 25 mg/mL ofmolidustat. Approval of the API will be undertaken concurrently with this application.
The proposed indication is for the treatment of anaemia associated with Chronic Kidney Disease (CKD) in cats.