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
46810 - FARMOZINE 900 WG HERBICIDE
49552 - GESAPRIM GRANULES 900 WG HERBICIDE
64206 - ENFORCER 75-D HERBICIDE
92617 - GESAPRIM 900WG Herbicide
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
80823 - DINON 700 WG FUNGICIDE
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
39578 - PEPTOSYL BISMUTH SALICYLATE ORAL SUSPENSION
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
82715 - Glymount 540K Herbicide
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
68781 - PYRINEX SUPER INSECTICIDE / MITICIDE
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
59872 - CHEMAG SENTINEL 800 INSECTICIDE SPRAY
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
61360 - RUSTLER SELECTIVE HERBICIDE
87920 - F.S.A. Propyzamide 500 SC Herbicide
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
67858 - ANTAGONIST PRO RESIDUAL ANT INSECTICIDE
67858 - ANTAGONIST PRO RESIDUAL INSECTICIDE
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
59486 - CYAN PLANT GROWTH REGULATOR
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
89148 - Conquest Preceed 850 WG Herbicide
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
52518 - SIPCAM ECHO 720 FUNGICIDE
63122 - CAMPBELL CHEERS 720 WEATHERSHIELD FUNGICIDE
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.
Description of data provided
Data no
257306Title
Report 46687 - PK study formulationStudy date
2019Publication
-Data no
257312Title
Report 46296 (D) - Ocular irritation studyStudy date
2018Publication
-Data no
257329Title
Report 38887 (D) - Oral toxicologyStudy date
2010Publication
-Data no
257335Title
Report 46315 - Skin irritation studyStudy date
2018Publication
-Data no
257358Title
A Conserved Family of Prolyl-4-Hydroxylases That Modify HIF.Study date
2001Publication
Science Vol. 294, Issue 5545, pp. 1337-1340. DOI: 10.1126/science.1066373Auth party contact address
-Data no
257429Title
Report 38902 (D) - Sub-chronic study lab animalStudy date
2012Publication
-Data no
257398Title
Report 38893 (D) - DNA synthesis rat liverStudy date
2010Publication
-Data no
257352Title
Report 38906 (D) - Developmental study ratsStudy date
2015Publication
-Data no
257435Title
Report 38901f (D) - Sub-chronic oral lab animalsStudy date
2012Publication
-Data no
257289Title
Report 44240e - TASStudy date
2016Publication
-Data no
257389Title
Report 38899 - Phototoxicity assayStudy date
2012Publication
-Data no
257346Title
Report 38907 - Developmental study rabbitsStudy date
2015Publication
-Data no
257295Title
Ref 2 - Project planStudy date
1 August 2023Publication
-Data no
257392Title
Report 46790 - Investigators Brochure APIStudy date
2019Publication
-Data no
257415Title
Report 38901a - Sub-chronic oral lab animalsStudy date
2012Publication
-Data no
257315Title
Report 38883 - Oral toxicologyStudy date
2010Publication
-Data no
257409Title
Report 38888 - Short term study dogsStudy date
2010Publication
-Data no
257421Title
Report 38903a - Sub-chronic oral lab animalStudy date
2012Publication
-Data no
257366Title
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human UseStudy date
2012Publication
ICH Topic S10. EMA/CHMP/ICH/752211/2012.Auth party contact address
-Data no
257372Title
FDA. (2007). Summary basis for approval of Mircera (BLA 125164).Pharmacology reviews a,bStudy date
2007Publication
-Data no
257309Title
Report 45163 (D) - Dermal absorption studyStudy date
2017Publication
-Data no
257286Title
Report 44240b - TASStudy date
2016Publication
-Data no
257401Title
Report 38885 (D) - toxicology additonal dataStudy date
2010Publication
-Data no
257378Title
Report 38891 - Micronucleus test - miceStudy date
2007Publication
-Data no
257355Title
Hypoxia-Inducible Factors in Physiology and MedicineStudy date
2012Publication
Cell. 2012 February 3; 148(3): 399???408. doi:10.1016/j.cell.2012.01.021Auth party contact address
-Data no
257432Title
Report 38901c (D) - Sub-chronic oral lab animalsStudy date
2012Publication
-Data no
257332Title
Report 46355 (D) - Ocular irritation studyStudy date
2018Publication
-Data no
257303Title
Report PH-39762 - Metabolism otherStudy date
2017Publication
-Data no
257386Title
Prior bleeding enhances the sensitivity of the in vivo micronucleus testStudy date
1991Publication
Mutation Research Letters 264, 109- 11Auth party contact address
-Data no
257292Title
Report 44240c (D) - TASStudy date
2016Publication
-Data no
257349Title
Report 46940 (D) Developmental study ratsStudy date
2018Publication
-Data no
257338Title
Report 46320 (D) - Skin sensitization studyStudy date
2018Publication
-Data no
257395Title
46938 (D) - toxicology additional dataStudy date
2016Publication
-Data no
257438Title
Report 38903c (D) - Sub-chronic oral lab animalStudy date
2012Publication
-Data no
257326Title
Report 38895 (D) - Acute toxicityStudy date
2009Publication
-Data no
257375Title
Von Hipple- Lindau protwin in the RPE is essential for normal ocular growth and vascular development.Study date
2012Publication
Development 139: 2340- 2350Auth party contact address
-Data no
257412Title
Report 38896 (D) - Short term oral lab animalStudy date
2010Publication
-Data no
257318Title
Report 44082 - Oral and intravenous toxicologyStudy date
2010Publication
-Data no
257369Title
Report 44083 - Oral and intravenous toxicologyStudy date
2010Publication
-Data no
257418Title
Report 38901d - Sub-chronic oral lab animalsStudy date
2012Publication
-Data no
257333Title
Report 46287 (D) - Skin sensitization studyStudy date
2019Publication
-Data no
257404Title
APVMA Part 3 Toxicology OverviewStudy date
1 August 2023Publication
-Data no
257310Title
Report 46355 - Ocular irritation studyStudy date
2018Publication
-Data no
257427Title
Report 38898 (D) - Sub-chronic study dogsStudy date
2012Publication
-Data no
257287Title
Report 44240c - TASStudy date
2016Publication
-Data no
257381Title
Effect of erythroietin on the micronucleus test.Study date
1989Publication
Environmental and Molecular Mutagenesis 13, 314- 318Auth party contact address
-Data no
257304Title
Report PH-37906 - Metabolism other animalsStudy date
2016Publication
-Data no
257433Title
Report 38901d (D) - Sub-chronic oral lab animalsStudy date
2012Publication
-Data no
257350Title
Report 44312 - Critical evaluation developmental toxicityStudy date
2016Publication
-Data no
257387Title
Evaluation of nongenotoxic and genotoxic factors modulating the frequency of micronucleated erythrocytes in the peripheral blood of miceStudy date
1985Publication
Cell Biology and Toxicology 1, 197- 211 1985Auth party contact address
-Data no
257341Title
Report 46913 (D) - Carcinogenicity study ratsStudy date
2019Publication
-Data no
257396Title
Retinopathy of Prematurity: Current concepts in Molecular PathogenesisStudy date
2009Publication
Seminars in Ophthalmology 24:2, 77-81Auth party contact address
-Data no
257321Title
Report 44088 - Oral and iv toxicologyStudy date
2011Publication
-Data no
257327Title
Report 38889 (D) - Oral toxicologyStudy date
2010Publication
-Data no
257364Title
Report 46937 - toxicology other informationStudy date
2016Publication
-Data no
257413Title
EFSA 2017. Re- evaluation of mono- and diglycerides of fatty acids (E471) as food additivesStudy date
2017Publication
EFSA Journal 15: 5045Auth party contact address
-Data no
257370Title
Report 44091 - Toxicology additional informationStudy date
2010Publication
-Data no
257330Title
Report 38883 (D)- Oral toxicologyStudy date
2010Publication
-Data no
257407Title
Apx 3-3 - User Safety Risk AssessmentStudy date
1 August 2023Publication
-Data no
257353Title
Report 38907 (D) - Developmental study rabbitsStudy date
2015Publication
-Data no
257384Title
Comparative studies in induction of micronuclei by three genetically recombinant and urinary human erythropoietinsStudy date
1993Publication
Mutagenesis 8, 237- 241Auth party contact address
-Data no
257307Title
Ref 36 - Metabolism other informationStudy date
2022Publication
-Data no
257430Title
Report 38901a (D) - Sub-chronic oral lab animalsStudy date
2012Publication
-Data no
257290Title
Report 44240a (D) - TASStudy date
2016Publication
-Data no
257301Title
Report PH-40564 - Metabolism lab animalsStudy date
2018Publication
-Data no
257436Title
Report 38903a (D) - Sub-chronic oral lab animalStudy date
2012Publication
-Data no
257347Title
Report 46940 - Developmental study ratsStudy date
2018Publication
-Data no
257390Title
EFSA, 2012. Scientific opinion on the re- evaluation of butylated hydroxytoluene BHT (E 321) as a food additive.Study date
2012Publication
EFSA Journal 2012: 10: 2588Auth party contact address
-Data no
257344Title
Report 38905 - Developmental study ratsStudy date
2014Publication
-Data no
257393Title
Report 38890 (D) - Forward cell mutationStudy date
2009Publication
-Data no
257416Title
Report 38901b - Sub-chronic oral lab animalsStudy date
2012Publication
-Data no
257298Title
Report 44092 - Pharmacological distribution data ratsStudy date
2015Publication
-Data no
257410Title
Report 38888 (D) - Short term study dogsStudy date
2010Publication
-Data no
257361Title
Oxygen sensing by HIF hydroxylases.Study date
2004Publication
Nature Reviews Molecular Cell Biology Vol. 5, 343???354Auth party contact address
-Data no
257373Title
Excessive erythrocytosis in adult mice overexpressing erythropoietin leads to hepatic, renal, neuronal, and muscular degenerationStudy date
2006Publication
A.J.Physiol.Regul.Integr.Comp.Physiol. 291, R947- R956Auth party contact address
-Data no
257424Title
Report 38898 - Sub-chronic study dogsStudy date
2012Publication
-Data no
257324Title
Report 38900 - sub-acute oral lab animalStudy date
2012Publication
-Data no
257367Title
Report 38882 - other informationStudy date
2010Publication
-Data no
257285Title
Report 44240a - TASStudy date
2016Publication
-Data no
257425Title
Report 38904 - Sub-chronic study dogsStudy date
2012Publication
-Data no
257431Title
Report 38901b (D) - Sub-chronic oral lab animalsStudy date
2012Publication
-Data no
257402Title
Report 46790 (D) - Investigators Brochure APIStudy date
2019Publication
-Data no
257408Title
Report 38896 - Sub-acute oral lab animalsStudy date
2010Publication
-Data no
257379Title
Report 38894 - Cytogenetic study miceStudy date
2011Publication
-Data no
257356Title
Molecular basis of hypoxia-induced erythropoietin expression.Study date
1996Publication
Curr.Opin.Hematol.3; 156- 162Auth party contact address
-Data no
257339Title
Report 46913 - Carcinogenicity study ratsStudy date
2019Publication
-Data no
257302Title
Report 44094 - Metabolism other informationStudy date
2010Publication
-Data no
257385Title
Induction of micronucleated erythrocytes by recombinant human erythropoietinStudy date
1993Publication
Mutagenesis 8, 221-229Auth party contact address
-Data no
257348Title
Report 46941 - Developmental study ratsStudy date
2019Publication
-Data no
257293Title
Report 44240d (D) - TASStudy date
2016Publication
-Data no
257439Title
Report 38903d (D) - Sub-chronic oral lab animalStudy date
2012Publication
-Data no
257299Title
Report 44098 - Metabolism lab animalStudy date
2016Publication
-Data no
257376Title
Report 38892 - Salmonella/Microsome testStudy date
2009Publication
-Data no
257313Title
Report 38889 - Oral toxicologyStudy date
2010Publication
-Data no
257325Title
38884 (D) - toxicology additonal dataStudy date
2010Publication
-Data no
257362Title
Ref 8 Toxicology other informationStudy date
2017Publication
ChemMedChem 2018, 13, 988 ??? 1003Auth party contact address
-Data no
257411Title
Report 38900 (D) - Short term lab animalStudy date
2012Publication
-Data no
257419Title
Report 38901e - Sub-chronic oral lab animalsStudy date
2012Publication
-Data no
257319Title
Report 44084 - Oral toxicologyStudy date
2011Publication
-Data no
257368Title
Report 38885 - toxicology additional dataStudy date
2010Publication
-Data no
257428Title
Report 38904 (D) - Sub-chronic study dogsStudy date
2012Publication
-Data no
257336Title
Report 46320 - Skin sensitization studyStudy date
2018Publication
-Data no
257359Title
C. elegans EGL-9 and Mammalian Homologs Define a Family of Dioxygenases that Regulate HIF by Prolyl Hydroxylation.Study date
2001Publication
Cell, Vol. 107, 43???54,Auth party contact address
-Data no
257305Title
Report 44101 - Metabolism otherStudy date
2016Publication
-Data no
257382Title
The micronucleus test and erythropoiesis. Effects of erythropoietin and a mutagen on the ratio of polychromatic to normochromatic erythrocytes (P/ N ratio).Study date
1989Publication
Mutagenesis 4, 420- 424Auth party contact address
-Data no
257405Title
42176 - summary user safetyStudy date
17 June 2015Publication
-Data no
257388Title
Report of the IWGT working group on strategies and interpretation of regulatory in vivo tests: I. Increases in micronucleated bone marrow cells in rodents that do not indicate genotoxic hazardStudy date
2007Publication
Mutation Research/ Genetic Toxicology and Environmental Mutagenesis 627, 78- 91Auth party contact address
-Data no
257399Title
Report 38891 (D) - Micronucleus test - miceStudy date
2007Publication
-Data no
257342Title
Report 46939 (D) - Carcinogenicity study miceStudy date
2018Publication
-Data no
257296Title
Report 48239 - Plasma protein binding various speciesStudy date
2015Publication
-Data no
257345Title
Report 38906 - Developmental study ratsStudy date
2015Publication
-Data no
257322Title
Report 48019 - Oral and iv toxicologyStudy date
2021Publication
-Data no
257422Title
Report 38903b - Sub-chronic oral lab animalStudy date
2012Publication
-Data no
257316Title
Report 38884 - toxicology additional dataStudy date
2010Publication
-Data no
257328Title
Report 38886 (D) - Oral toxicologyStudy date
2010Publication
-Data no
257365Title
Report 46938 - toxicology other inStudy date
2016Publication
-Data no
257354Title
Report 44313 - Critical evaluation genotoxicityStudy date
2016Publication
-Data no
257360Title
Structure of a HIF-1??-pVHL Complex: Hydroxyproline Recognition in Signaling.Study date
2001Publication
Science:Vol. 296, Issue 5574, pp. 1886-1889, DOI: 10.1126/science.1073440Auth party contact address
-Data no
257377Title
Report 38890 - Forward cell mutationStudy date
2009Publication
-Data no
257383Title
Genotoxicity of genetic recombinant human erythropoietin in a novel test systemStudy date
1993Publication
Mutagenesis 8, 231- 236Auth party contact address
-Data no
257308Title
Report 45163 - Dermal absorption studyStudy date
2017Publication
-Data no
257406Title
3-2 - Applicant Written Summary (EU) Part 3a SafetyStudy date
26 July 2023Publication
-Data no
257331Title
Report 46688 - Formulation Oral toxicityStudy date
2019Publication
-Data no
257291Title
Report 44240b (D) - TASStudy date
2016Publication
-Data no
257400Title
Report 38894 (D) - Cytogenetic study miceStudy date
2011Publication
-Data no
257337Title
Report 46287 - Skin sensitization studyStudy date
2019Publication
-Data no
257437Title
Report 38903b (D) - Sub-chronic oral lab animalStudy date
2012Publication
-Data no
257391Title
EFSA, 2019. Opinion of the follow-up reevaluation of sorbic acid (E 200) and potassium sorbate (E 202) as Food additives.Study date
2019Publication
EFSA Journal 17: 5625Auth party contact address
-Data no
257394Title
Report 46937 (D) - toxicology additional dataStudy date
2016Publication
-Data no
257343Title
Report 46941 (D) - Developmental study ratsStudy date
2019Publication
-Data no
257297Title
Report 44112 -Plasma protein binding various speciesStudy date
2016Publication
-Data no
257323Title
Report 38895 - Acute toxicology oralStudy date
2009Publication
-Data no
257801Title
GMP EvidenceStudy date
2021Publication
-Data no
257374Title
Reduced cerebral blood flow but elevated cerebral glucose metabolic rate in erythropoietin overexpressing transgenic mice with excessive erythrocytosisStudy date
2007Publication
Journal of Cerebral Blood Flow & Metabolism 27, 469????????476Auth party contact address
-Data no
257423Title
Report 38897 - Sub-chronic study dogsStudy date
2011Publication
-Data no
257317Title
Report 38887 - Oral toxicologyStudy date
2010Publication
-Data no
257417Title
Report 38901c - Sub-chronic oral lab animalsStudy date
2012Publication
-Data no
257357Title
Regulated oxygen sensing by protein hydroxylation in renal erythropoietin-producing cells.Study date
2010Publication
Am J Physiol Renal Physiol 298: F1287???F1296, doi:10.1152/ajprenal.00736.2009.Auth party contact address
-Data no
257334Title
Report 46315 (D) - Skin irritation studyStudy date
2018Publication
-Data no
257311Title
Report 46296 - Ocular irritation studyStudy date
2018Publication
-Data no
257288Title
Report 44240d - TASStudy date
2016Publication
-Data no
257426Title
Report 38897 (D) - Sub-chronic study dogsStudy date
2011Publication
-Data no
257403Title
Von Hipple- Lindau protein in the RPE is essential for normal ocular growth and vascular development.Study date
2012Publication
Development 139: 2340- 2350Auth party contact address
-Data no
257380Title
Report 38893 - DNA synthesis rat liverStudy date
2010Publication
-Data no
257351Title
Report 38905 (D) - Developmental study ratsStudy date
2014Publication
-Data no
257434Title
Report 38901e (D) - Sub-chronic oral lab animalsStudy date
2012Publication
-Data no
257340Title
Report 46939 - Carcinogenicity study miceStudy date
2018Publication
-Data no
257397Title
Report 38892 (D) - Salmonella/Microsome testStudy date
2009Publication
-Data no
257294Title
Report 44240e (D) - TASStudy date
2016Publication
-Data no
257300Title
Report PH-37906 - Metabolism lab animalStudy date
2016Publication
-Data no
257363Title
Report PH36104 - toxicology other informationStudy date
2010Publication
-Data no
257314Title
Report 38886 - Oral toxicologyStudy date
2010Publication
-Data no
257371Title
Report 44093 - Toxicology additional informationStudy date
2016Publication
-Data no
257414Title
Report 38902 - sub-chronic oral lab animalStudy date
2012Publication
-Data no
257420Title
Report 38901f - Sub-chronic oral lab animalStudy date
2012Publication
-Data no
257320Title
Report 44087 - Oral and iv toxicologyStudy date
2015Publication
-
LEVABAMAX COMBINATION POUR-ON FOR CATTLE
Application Date
22-Sep-2023
Application Number
141121
Application Date
22-Sep-2023Application Number
141121Application Details
Product name
LEVABAMAX COMBINATION POUR-ON FOR CATTLEProduct no
93975Applicant name
NUTRIEN AG SOLUTIONS LIMITEDApplication purpose and description of use
Registration of a 10 mg/ mL abamectin, 200 mg/ mL levamisole pour-on product for the treatment and control of roundworms, including macrocyclic lactones or levamisole resistant strains, and external parasites in cattle.Active constituents
Active constituent name
83372 - AbamectinActive constituent name
83379 - LevamisoleDescription of data provided
Data no
257674Title
Product specificationStudy date
23/6/2023Publication
In-houseAuth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK AustraliaReference Details
60752 - ECLIPSE COMBINATION POUR-ON FOR CATTLE
ULTRATHOR X WATER-BASED TERMITICIDE AND INSECTICIDE
Application Date
22-Sep-2023
Application Number
141406
Application Date
22-Sep-2023Application Number
141406Application Details
Product name
ULTRATHOR X WATER-BASED TERMITICIDE AND INSECTICIDEProduct no
64449Applicant name
ENSYSTEX AUSTRALASIA PTY LTDApplication purpose and description of use
Variation of product registration and label approval to modify the Directions for Use and general instructions.Active constituents
Active constituent name
58418 - FIPRONILDescription of data provided
Data no
258950Title
Field Evaluation Of The Effectiveness Of ULTRATHOR Against A Range Of Ant Species.Study date
16/01/2012Publication
-Data no
258952Title
Termidor Residual Termiticide and Insecticide label 54624/121259Study date
18/10/2019Publication
-Auth party contact address
-Data no
258949Title
Field Evaluation of the Effectiveness of ULTRATHOR??? Water-based Termiticide and Insecticide against a range of ant species in Western AustraliaStudy date
11/09/2023Publication
-Data no
258953Title
Termidor HE Residual Termiticide label 80820/108128Study date
31/05/2017Publication
-Auth party contact address
-Data no
258948Title
Field Evaluation of the Effectiveness of ULTRATHOR??? X Water-based Termiticide and Insecticide against a range of ant species in QueenslandStudy date
11/09/2023Publication
-Data no
258951Title
Agricultural chemicals efficacy and safety technical reportStudy date
18/01/2023Publication
-Data no
258954Title
Part 8 SummaryStudy date
September 2023Publication
-
IMTRADE METHOMYL 225 INSECTICIDE
Application Date
22-Sep-2023
Application Number
141410
Application Date
22-Sep-2023Application Number
141410Application Details
Product name
IMTRADE METHOMYL 225 INSECTICIDEProduct no
63201Applicant name
IMTRADE AUSTRALIA PTY LTDApplication purpose and description of use
Variation of product registration and label approval to amend Pack Size Range from 1L-200L to 1L-1000L to allow for greater marketability of product along with updating the Product Label by addition of Spray Drift Restraints, referring to the product as METHOMYL 225 through, update of Application comments, update of Storage & Disposal Instructions to accommodate new Pack Size Range, update of Safety Directions and update of First Aid Instructions.Active constituents
Active constituent name
59753 - METHOMYLDescription of data provided
Data no
258995Title
Imtrade Methomyl 225 Insecticide - RLP_V1 pending 18/09/2023 MARKED COPYStudy date
18/09/2023Publication
-Data no
258994Title
Advice of NV submission for product 63201Study date
07/06/2022Publication
-Reference Details
92346 - IMTRADE ACTIVIST 225 VERIPHY SL INSECTICIDE
Sulfadimidine
Application Date
21-Sep-2023
Application Number
141341
Application Date
21-Sep-2023Application Number
141341Application Details
Product name
SulfadimidineActive name
SulfadimidineApplicant name
INCA (FLIGHT) CO PTY LTDApplication purpose and description of use
Approval of pharmacopoeia active constituent.Description of data provided
Data no
258803Title
Certificate of Analysis 210314 BP2012 SulphadimidineStudy date
March 2021Publication
Sulphadimidine 210314 - 20126.pdf;533755Data no
258804Title
Certificate of Analysis 201235 BP2012 SulphadimidineStudy date
December 2020Publication
-Data no
258904Title
Sulphadimidine CoAsStudy date
2021Publication
-Data no
258805Title
Sulfadimidine Ph. Eur. monograph 0295Study date
2012Publication
MOA FOR SULFADIMIDINE(2012).pdf;87239Data no
258802Title
Certificate of Analysis 211023 BP2012 Sulphadimidine .Study date
October 2021Publication
Sulphadimidine 211023 - 20341 (1).pdf;258018
CEPRALOCK
Application Date
21-Sep-2023
Application Number
141366
Application Date
21-Sep-2023Application Number
141366Application Details
Product name
CEPRALOCKProduct no
89964Applicant name
INTERVET AUSTRALIA PTY LIMITEDApplication purpose and description of use
Variation of product registration to extend product shelf lifeActive constituents
Active constituent name
57108 - BISMUTH SUBNITRATEDescription of data provided
Data no
258892Title
Executive SummaryStudy date
14 September 2023Publication
-Data no
258893Title
Stability ReportStudy date
12 August 2022Publication
-Data no
258894Title
Product SpecificationsStudy date
July 2023Publication
-
Dimethomorph Technical
Application Date
21-Sep-2023
Application Number
141394
Application Date
21-Sep-2023Application Number
141394Application Details
Product name
Dimethomorph TechnicalActive name
Dimethomorph TechnicalApplicant name
Shandong Rainbow International Co LtdApplication purpose and description of use
Approval of Dimethomorph Technical for use in agricultural chemical products.Description of data provided
Data no
258932Title
The Statement of Batch Size of Dimethomorph Technical in 5-Batch ReportStudy date
2023Publication
-Data no
258929Title
MANUFACTURE PROCESS OF DIMETHOMORPH TECHNICALStudy date
2020Publication
-Data no
258930Title
THE JUSTIFICATION OF IMPURITIES OF DIMETHOMORPH TECHNICALStudy date
2020Publication
-Data no
258927Title
Chemistry &Manufacturing DossierStudy date
05/09/2023Publication
-Data no
258933Title
COAStudy date
JUL. 20, 2023Publication
-Data no
258928Title
Determination of Active Content and Impurity Profile of DimethomorphStudy date
13 Mar 2020Publication
-Data no
258931Title
DocStudy date
2023Publication
-
ACIBENZOLAR-S-METHYL
Application Date
20-Sep-2023
Application Number
141300
Application Date
20-Sep-2023Application Number
141300Application Details
Product name
ACIBENZOLAR-S-METHYLActive name
ACIBENZOLAR-S-METHYLApplicant name
SYNGENTA AUSTRALIA PTY LTDApplication purpose and description of use
Approval of Acibenzolar-S-Methyl for use in agricultural products.Description of data provided
Data no
258663Title
Statement on IR Spectra of Acibenzolar-S-Methyl technicalStudy date
17 June 2021Publication
-Data no
258669Title
CGA245704 - Determination of by-products in CGA245704 Technical by High Performance Liquid Chromatography and Gas ChromatographyStudy date
02 May 2016Publication
-Data no
258660Title
Part 2 - Chemistry and ManufactureStudy date
04 September 2023Publication
-Data no
258666Title
Declaration of CompositionStudy date
21 August 2023Publication
-Data no
258661Title
Statement on UV wavelength screening of Acibenzolar-S-Methyl technical by Diode Array DetectorStudy date
17 June 2021Publication
-Data no
258664Title
Statement on Mass Spectra of Acibenzolar-S-Methyl TechnicalStudy date
17 June 2021Publication
-Data no
258667Title
Acibenzolar-S-Methyl (CGA245704) - Analysis of Five Representative batchesStudy date
03 August 2023Publication
-Data no
258670Title
Acibenzolar-S-Methyl Technical (CGA245704) - Validation of Analytical Method SA-1241Study date
10 March2016Publication
-Data no
258665Title
Manufacturing Process - Acibenzolar-S-MethylStudy date
20 April 2021Publication
-Data no
258671Title
CGA245704 - Validation of Analytical method SB-124/1Study date
02 August 2016Publication
-Data no
258662Title
Statement in NMR Spectra of Acibenzolar-S-Methyl technicalStudy date
17 June 2021Publication
-Data no
258668Title
CGA245704 - Determination of CGA245704 in Acibenzolar-S-Methyl technical by Gas Chromatography - SA-124/1Study date
15 February 2016Publication
-
TIAMUPHARM LIQUID
Application Date
20-Sep-2023
Application Number
141342
Application Date
20-Sep-2023Application Number
141342Application Details
Product name
TIAMUPHARM LIQUIDProduct no
59465Applicant 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
82709 - TIAMULIN HYDROGEN FUMARATEActive constituent name
56387 - TIAMULIN FUMARATEActive constituent name
84120 - TIAMULIN HYDROGEN FUMARATE
MS MegaDes Novo
Application Date
19-Sep-2023
Application Number
140596
Application Date
19-Sep-2023Application Number
140596Application Details
Product name
MS MegaDes NovoProduct no
93827Applicant name
STOCKYARD INDUSTRIES PTY LTDApplication purpose and description of use
Registration of a Glutaraldehyde and Alkyl (C12C16) dimethylbenzylammoniumchloride product for use as a disinfectant for animal housing and vehicles used for animal transport.Description of data provided
Data no
256834Title
Product stability MS MegaDes NovoStudy date
2023Publication
-Data no
256831Title
MS MegaDes Novo Product CompositionStudy date
23 August 2023Publication
-Data no
256837Title
Leaflet informationStudy date
2023Publication
-Data no
256828Title
Certificate of conformity ISOStudy date
2023Publication
-Data no
256829Title
MS MegaDes Novo Product Data SheetStudy date
September 2022Publication
-Data no
256832Title
Production information MS MegaDes NovoStudy date
2023Publication
-Data no
256835Title
MS MegaDes Novo Efficacy testStudy date
2023Publication
-Data no
256836Title
Packaging information & label MS MegaDes NovoStudy date
2023Publication
-Data no
256833Title
Benzalkonium chloride determination (Bardac DM50) 3.Study date
09/01/22Publication
-Data no
256830Title
CERTIFICATE OF ANALYSISStudy date
02/04/23Publication
-Reference Details
88612 - TH5 Broad Spectrum Disinfectant against Bacteria, Fungi and Viruses
Metacoxx Oral Suspension for Cats
Application Date
19-Sep-2023
Application Number
141061
Application Date
19-Sep-2023Application Number
141061Application Details
Product name
Metacoxx Oral Suspension for CatsProduct no
83287Applicant name
DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.Application purpose and description of use
Variation of product registration and label approval to introduce an additional pack size and update sites of manufacture.Active constituents
Active constituent name
82924 - MeloxicamDescription of data provided
Data no
257510Title
Stability tablesStudy date
19 June 2023Publication
UnpublishedData no
257511Title
Product Specification and DrawingStudy date
27 October 2014Publication
UnpublishedData no
257509Title
Chemistry 4Study date
August 2023Publication
Unpublished
SPIROTETRAMAT
Application Date
19-Sep-2023
Application Number
141212
Application Date
19-Sep-2023Application Number
141212Application Details
Product name
SPIROTETRAMATActive name
SPIROTETRAMATApplicant name
Hebei Lanrun Plant Protection Technology Co., Ltd.Application purpose and description of use
Approval of SPIROTETRAMAT for use in agricultural chemical products.Description of data provided
Data no
258448Title
Preliminary Analysis and Validation of Analytical Methods of Spirotetramat TC ???Validation of Analytical Methodology for the Assay of Active Ingredient, Impurities and Subsequent 5-Batch Analysis of Spirotetramat TCStudy date
June 2023Publication
-Data no
258451Title
Declaration of compositionStudy date
June 2023Publication
-Data no
258446Title
Available packages for Spirotetramat TCStudy date
June 2023Publication
-Data no
258452Title
Preliminary Analysis and Enforcement Analytical Method of Spirotetramat TC ???Validation of Analytical Methodology for the Assay of Active Ingredient, Impurities and Subsequent 5-Batch Analysis of Spirotetramat TCStudy date
June 2023Publication
-Data no
258449Title
Preliminary Analysis and Validation of Analytical Methods of Spirotetramat TC ???Validation of Analytical Methodology for the Assay of Active Ingredient, Impurities and Subsequent 5-Batch Analysis of Spirotetramat TCStudy date
June 2023Publication
-Data no
258450Title
Preliminary Analysis and Enforcement Analytical Method of Spirotetramat TC ???Validation of Analytical Methodology for the Assay of Active Ingredient, Impurities and Subsequent 5-Batch Analysis of Spirotetramat TCStudy date
June 2023Publication
-Data no
258447Title
Statement of 5 Batch Size and typical batch size of Spirotetramat TechnicalStudy date
June 2023Publication
-Data no
258445Title
Spirotetramat manufacturing process and impurities formation description.Study date
June 2023Publication
-
Cyproconazole
Application Date
19-Sep-2023
Application Number
141356
Application Date
19-Sep-2023Application Number
141356Application Details
Product name
CyproconazoleActive name
CyproconazoleApplicant name
SHANGHAI E-TONG CHEMICAL CO LTDApplication purpose and description of use
Approval of cyproconazole for use in agricultural chemical products.Description of data provided
Data no
258866Title
Part 2 Chemistry and ManufacturingStudy date
2023Publication
-Data no
258872Title
COA of cyproconazole technicalStudy date
2023Publication
-Data no
258869Title
Five Batches Analysis of Cyproconazole TGAI, Amendment No1 to Final Report, Study Number R-23-500(1-5)Study date
2023Publication
-Data no
258870Title
Declaration of Composition (DoC), Declaration of Manufacture (DoM) and Letter of Support for Cyproconazole TGAI,Study date
2023Publication
-Data no
258873Title
Cyproconazole MATERIAL SAFETY DATA SHEETStudy date
2023Publication
-Data no
258867Title
Description Of Manufacturing Process Of Cyproconazole And Impurity Information of CyproconazoleTechnicalStudy date
2023Publication
-Data no
258868Title
Five Batches Analysis of Cyproconazole TGAI, Study Number R-23-500(1-5)Study date
2023Publication
-Data no
258871Title
Analysis method for cyproconazole technicalStudy date
2023Publication
-
Keaks Clean Veterinary Disinfectant
Application Date
19-Sep-2023
Application Number
141369
Application Date
19-Sep-2023Application Number
141369Application Details
Product name
Keaks Clean Veterinary DisinfectantProduct no
94058Applicant name
INTERCHEM PTY LTDApplication purpose and description of use
Registration of a 54g/L Benzalkonium chloride and 4g/L Poly (hexamethylene biguanide hydrochloride) liquid concentrate product for multipurpose disinfectant for all hard surfaces, equipment and airspaces.Description of data provided
Data no
258899Title
Product SpecificationsStudy date
13/09/2023Publication
-Reference Details
54149 - F10SC VETERINARY DISINFECTANT
Kresoxim-methyl
Application Date
18-Sep-2023
Application Number
140992
Application Date
18-Sep-2023Application Number
140992Application Details
Product name
Kresoxim-methylActive name
Kresoxim-methylApplicant name
UNITED CROPSCIENCE PTE., LTD.Application purpose and description of use
Approval of Kresoxim-methyl for use in agricultural chemical products.Description of data provided
Data no
257089Title
Explanation letter for change of nameStudy date
May 2023Publication
-Data no
257086Title
Packing Specification of Kresoxim-methyl TechnicalStudy date
July 2023Publication
-Data no
257083Title
Technical Report Industrial Synthesis and Formation of Impurities. KRESOXIM - METHYLStudy date
July 2023Publication
-Data no
257081Title
Determination of active constituent and impurity profile of Kresoxim-methylStudy date
November 2016Publication
-Data no
257084Title
Declaration of compositionStudy date
July 2023Publication
-Data no
257087Title
Statement of 5 Batch Size and Typical Batch Size of Kresoxim-methyl TechnicalStudy date
July 2023Publication
-Data no
257082Title
Determination of active constituent and impurity profile of Kresoxim-methylStudy date
November 2016Publication
-Data no
257088Title
Statement for Manufacturing ProcessStudy date
July 2023Publication
-Data no
257085Title
Analytical method of Kresoxim-methyl and validationStudy date
July 2023Publication
-
Trifloxystrobin
Application Date
18-Sep-2023
Application Number
141088
Application Date
18-Sep-2023Application Number
141088Application Details
Product name
TrifloxystrobinActive name
TrifloxystrobinApplicant name
UNITED CROPSCIENCE PTE., LTD.Application purpose and description of use
Approval of Trifloxystrobin for use in agricultural chemical products.Description of data provided
Data no
257627Title
Trifloxystrobin Technical Manufacture processStudy date
July 2023Publication
-Data no
257630Title
Packing Specification of Trifloxystrobin TechnicalStudy date
July 2023Publication
-Data no
257633Title
Explanation letter for the change of nameStudy date
May 2023Publication
-Data no
257631Title
Statement of 5 Batch Size and Typical Batch Size of Trifloxystrobin TechnicalStudy date
July 2023Publication
-Data no
257628Title
Declartion of compositionStudy date
August 2023Publication
-Data no
257629Title
Analysis of active ingredient Trifloxystrobin by HPLC-UVStudy date
June 2023Publication
-Data no
257632Title
Material Safety Data SheetStudy date
July 2023Publication
-Data no
257626Title
Determination of Active Content and Impurity Profile of TrifloxystrobinStudy date
April 2020Publication
-
Abamectin
Application Date
18-Sep-2023
Application Number
141174
Application Date
18-Sep-2023Application Number
141174Application Details
Product name
AbamectinActive name
AbamectinApplicant name
UNITED CROPSCIENCE PTE., LTD.Application purpose and description of use
Approval of Abamectin for use in agricultural chemical products.Description of data provided
Data no
258225Title
Validation of the method for determination of the active ingredient in Abamectin TechnicalStudy date
June 2023Publication
-Data no
258228Title
Statement of 5 Batch Size and Typical Batch Size of Abamectin TechnicalStudy date
June 2023Publication
-Data no
258222Title
Preliminary Analysis, Enforcement Analytical Method & Qualitative and Quantitative Profile of the test substance Abamectin Technical (Five Batch Analysis)Study date
November 2017Publication
-Data no
258223Title
Qualitative and Quantitative Profile of the test substance Abamectin Technical (Five Batch Analysis)Study date
09/2017Publication
-Data no
258226Title
Declaration of compositionStudy date
July 2023Publication
-Data no
258220Title
Qualitative and Quantitative Profile of the test substance Abamectin Technical (Five Batch Analysis)Study date
September 2016Publication
-Data no
258229Title
Statement for manufacturing processStudy date
June 2023Publication
-Data no
258221Title
Preliminary Analysis, Enforcement Analytical Method & Qualitative and Quantitative Profile of the test substance Abamectin Technical (Five Batch Analysis)Study date
September 2017Publication
-Data no
258227Title
Packing Specification of Abamectin TechnicalStudy date
June 2023Publication
-Data no
258224Title
MANUFACTURING PROCESS OF ABAMECTIN 95 % TECHStudy date
July 2023Publication
-
Vanquish Glypho 540 Herbicide
Application Date
18-Sep-2023
Application Number
141302
Application Date
18-Sep-2023Application Number
141302Application Details
Product name
Vanquish Glypho 540 HerbicideApplicant name
HEART AGRICULTURAL PTY LTDApplication purpose and description of use
Registration of a 540 g/L glyphosate present as the potassium salt SL soluble concentrate product for use as a non-selective herbicide for the control of many annual and perennial weeds.
EXPEDIENT SPRAY ADJUVANT
Application Date
18-Sep-2023
Application Number
141312
Application Date
18-Sep-2023Application Number
141312Application Details
Product name
EXPEDIENT SPRAY ADJUVANTProduct no
70378Applicant name
AUSTRALIAN ADJUVANTS PTY LTDApplication purpose and description of use
Variation of label approval to make a minor change to the active constituent statement.Active constituents
Active constituent name
60725 - ETHYL ESTERS OF CANOLA OIL FATTY ACIDSDescription of data provided
Data no
258718Title
Expedient Item 12 Background & ProposalStudy date
Sep 2023Publication
-
Demovit Herbicide
Application Date
18-Sep-2023
Application Number
141315
Application Date
18-Sep-2023Application Number
141315Application Details
Product name
Demovit HerbicideProduct no
94039Applicant name
Shandong Rainbow International Co LtdApplication purpose and description of use
Registration of a 340 g/L MCPA (present as the dimethylamine salt) 80 g/L DICAMBA (present as the dimethylamine salt) Soluble Concentrate (SL) product For the control of certain broadleaf weeds in winter cereals, pastures and non-crop areas..Active constituents
Active constituent name
53708 - DICAMBAActive constituent name
56234 - MCPAReference Details
86775 - OZCROP DICAMBA-M SL HERBICIDE
APIGUARD GEL FOR BEEHIVES
Application Date
18-Sep-2023
Application Number
141329
Application Date
18-Sep-2023Application Number
141329Application Details
Product name
APIGUARD GEL FOR BEEHIVESProduct no
65570Applicant name
VITA (EUROPE) LIMITEDApplication purpose and description of use
Variation of product registration to change the overseas site of manufacture.Description of data provided
Data no
258764Title
Evidence of GMPStudy date
Nov 2022Publication
N/A
Mortein Naturgard Crawling Insect Control Bomb Eucalyptus Scent
Application Date
18-Sep-2023
Application Number
141338
Application Date
18-Sep-2023Application Number
141338Application Details
Product name
Mortein Naturgard Crawling Insect Control Bomb Eucalyptus ScentProduct no
90976Applicant name
RB (HYGIENE HOME) AUSTRALIA PTY LTDApplication purpose and description of use
Variation of product registration and label approval to amend product specification and make changes to label text.Active constituents
Active constituent name
61830 - PERMETHRIN
F.S.A. LV Ester 680 Herbicide
Application Date
18-Sep-2023
Application Number
141349
Application Date
18-Sep-2023Application Number
141349Application Details
Product name
F.S.A. LV Ester 680 HerbicideProduct no
87250Applicant name
FOUR SEASONS AGRIBUSINESS PTY LTDApplication purpose and description of use
Variation of product registration to add a formulation.Active constituents
Active constituent name
61699 - 2,4-D-2-ETHYLHEXYL ESTERActive constituent name
68068 - 2,4-D-2-ETHYLHEXYL ESTERActive constituent name
47190 - 2,4-D-2-ETHYLHEXYL ESTERActive constituent name
61329 - 2,4-D-2-ETHYLHEXYL ESTERDescription of data provided
Data no
258863Title
Support for FSA - formulationStudy date
September 2023Publication
-Reference Details
69446 - AC ESCORT 680 HERBICIDE