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.
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
257676Title
Certificate of AnalysisStudy date
30/4/2020Publication
n/aData no
257677Title
Certificate of AnalysisStudy date
29/4/2020Publication
n/aData no
257678Title
Certificate of AnalysisStudy date
30/4/2020Publication
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
258865Title
Access to CCI and Protected dataStudy date
September 2023Publication
-Data no
258864Title
Support for FSA - formulationStudy 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
258922Title
GMP certificateStudy date
Jan 2023Publication
-Data no
258923Title
Application for modificationStudy date
Aug 2023Publication
n/aData no
258921Title
Cover letter - Clomicalm 80 variationStudy date
Sep 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
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
258904Title
Sulphadimidine CoAsStudy date
2021Publication
-Data no
258802Title
Certificate of Analysis 211023 BP2012 Sulphadimidine .Study date
October 2021Publication
Sulphadimidine 211023 - 20341 (1).pdf;258018Data 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
258805Title
Sulfadimidine Ph. Eur. monograph 0295Study date
2012Publication
MOA FOR SULFADIMIDINE(2012).pdf;87239
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
258894Title
Product SpecificationsStudy date
July 2023Publication
-Data no
258892Title
Executive SummaryStudy date
14 September 2023Publication
-Data no
258893Title
Stability ReportStudy date
12 August 2022Publication
-
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
258928Title
Determination of Active Content and Impurity Profile of DimethomorphStudy date
13 Mar 2020Publication
-Data no
258931Title
DocStudy date
2023Publication
-Data no
258932Title
The Statement of Batch Size of Dimethomorph Technical in 5-Batch ReportStudy date
2023Publication
-Data no
258933Title
COAStudy date
JUL. 20, 2023Publication
-Data no
258929Title
MANUFACTURE PROCESS OF DIMETHOMORPH TECHNICALStudy date
2020Publication
-Data no
258927Title
Chemistry &Manufacturing DossierStudy date
05/09/2023Publication
-Data no
258930Title
THE JUSTIFICATION OF IMPURITIES OF DIMETHOMORPH TECHNICALStudy date
2020Publication
-
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
258668Title
CGA245704 - Determination of CGA245704 in Acibenzolar-S-Methyl technical by Gas Chromatography - SA-124/1Study date
15 February 2016Publication
-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
258667Title
Acibenzolar-S-Methyl (CGA245704) - Analysis of Five Representative batchesStudy date
03 August 2023Publication
-Data no
258665Title
Manufacturing Process - Acibenzolar-S-MethylStudy date
20 April 2021Publication
-Data no
258666Title
Declaration of CompositionStudy date
21 August 2023Publication
-Data no
258670Title
Acibenzolar-S-Methyl Technical (CGA245704) - Validation of Analytical Method SA-1241Study date
10 March2016Publication
-Data no
258671Title
CGA245704 - Validation of Analytical method SB-124/1Study date
02 August 2016Publication
-Data no
258660Title
Part 2 - Chemistry and ManufactureStudy date
04 September 2023Publication
-Data no
258661Title
Statement on UV wavelength screening of Acibenzolar-S-Methyl technical by Diode Array DetectorStudy date
17 June 2021Publication
-Data no
258662Title
Statement in NMR Spectra of Acibenzolar-S-Methyl technicalStudy date
17 June 2021Publication
-Data no
258663Title
Statement on IR Spectra of Acibenzolar-S-Methyl technicalStudy date
17 June 2021Publication
-Data no
258664Title
Statement on Mass Spectra of Acibenzolar-S-Methyl TechnicalStudy date
17 June 2021Publication
-
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
256833Title
Benzalkonium chloride determination (Bardac DM50) 3.Study date
09/01/22Publication
-Data no
256830Title
CERTIFICATE OF ANALYSISStudy date
02/04/23Publication
-Data no
256832Title
Production information MS MegaDes NovoStudy date
2023Publication
-Data no
256831Title
MS MegaDes Novo Product CompositionStudy date
23 August 2023Publication
-Data no
256829Title
MS MegaDes Novo Product Data SheetStudy date
September 2022Publication
-Data no
256834Title
Product stability 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
256837Title
Leaflet informationStudy date
2023Publication
-Data no
256828Title
Certificate of conformity ISOStudy date
2023Publication
-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
257511Title
Product Specification and DrawingStudy date
27 October 2014Publication
UnpublishedData no
257509Title
Chemistry 4Study date
August 2023Publication
UnpublishedData no
257510Title
Stability tablesStudy date
19 June 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
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
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
258447Title
Statement of 5 Batch Size and typical batch size of Spirotetramat TechnicalStudy date
June 2023Publication
-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
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
258445Title
Spirotetramat manufacturing process and impurities formation description.Study date
June 2023Publication
-Data no
258446Title
Available packages for Spirotetramat TCStudy date
June 2023Publication
-Data no
258451Title
Declaration of compositionStudy 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
258871Title
Analysis method for cyproconazole technicalStudy date
2023Publication
-Data no
258872Title
COA of cyproconazole technicalStudy date
2023Publication
-Data no
258868Title
Five Batches Analysis of Cyproconazole TGAI, Study Number R-23-500(1-5)Study 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
258867Title
Description Of Manufacturing Process Of Cyproconazole And Impurity Information of CyproconazoleTechnicalStudy date
2023Publication
-Data no
258866Title
Part 2 Chemistry and ManufacturingStudy 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
-
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
257085Title
Analytical method of Kresoxim-methyl and validationStudy date
July 2023Publication
-Data no
257081Title
Determination of active constituent and impurity profile of Kresoxim-methylStudy date
November 2016Publication
-Data no
257082Title
Determination of active constituent and impurity profile of Kresoxim-methylStudy date
November 2016Publication
-Data no
257083Title
Technical Report Industrial Synthesis and Formation of Impurities. KRESOXIM - METHYLStudy date
July 2023Publication
-Data no
257084Title
Declaration of compositionStudy date
July 2023Publication
-Data no
257086Title
Packing Specification of Kresoxim-methyl TechnicalStudy date
July 2023Publication
-Data no
257087Title
Statement of 5 Batch Size and Typical Batch Size of Kresoxim-methyl TechnicalStudy date
July 2023Publication
-Data no
257088Title
Statement for Manufacturing ProcessStudy date
July 2023Publication
-Data no
257089Title
Explanation letter for change of nameStudy date
May 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
257626Title
Determination of Active Content and Impurity Profile of TrifloxystrobinStudy date
April 2020Publication
-Data no
257629Title
Analysis of active ingredient Trifloxystrobin by HPLC-UVStudy date
June 2023Publication
-Data no
257631Title
Statement of 5 Batch Size and Typical Batch Size of Trifloxystrobin TechnicalStudy date
July 2023Publication
-Data no
257627Title
Trifloxystrobin Technical Manufacture processStudy date
July 2023Publication
-Data no
257628Title
Declartion of compositionStudy date
August 2023Publication
-Data no
257630Title
Packing Specification of Trifloxystrobin TechnicalStudy date
July 2023Publication
-Data no
257632Title
Material Safety Data SheetStudy date
July 2023Publication
-Data no
257633Title
Explanation letter for the change of nameStudy date
May 2023Publication
-
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
258220Title
Qualitative and Quantitative Profile of the test substance Abamectin Technical (Five Batch Analysis)Study date
September 2016Publication
-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
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
258224Title
MANUFACTURING PROCESS OF ABAMECTIN 95 % TECHStudy date
July 2023Publication
-Data no
258226Title
Declaration of compositionStudy date
July 2023Publication
-Data no
258227Title
Packing Specification of 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
258229Title
Statement for manufacturing processStudy date
June 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
Pyridaben
Application Date
15-Sep-2023
Application Number
141224
Application Date
15-Sep-2023Application Number
141224Application Details
Product name
PyridabenActive name
PyridabenApplicant name
SHANDONG UNITED PESTICIDE INDUSTRY CO., LTDApplication purpose and description of use
Approval of (active) for use in agricultural and/or veterinary (delete as necessary) chemical products.Description of data provided
Data no
258484Title
Five Batches Analysis of Pyridaben TCStudy date
6/5/2023Publication
-Data no
258485Title
Confidential attachment Five Batches Analysis of Pyridaben TCStudy date
06/05/2023Publication
-Data no
258492Title
PART 2 CHEMISTRY AND MANUFACTURE - New Source of Approved Active Constituent PyridabenStudy date
10/06/2023Publication
-Data no
258482Title
Manufacturing Process and Quality Control of Pyridaben from a new manufacturing sourceStudy date
26/06/2023Publication
-Data no
258483Title
Declaration of Composition (DoC) for Pyridaben from a New Manufacturing SourceStudy date
25/06/2023Publication
-Data no
258486Title
COA 2-(tert-butyl)-4, 5-dichloro-2, 3-dihydropyridazin-3-oneStudy date
2023Publication
-Data no
258487Title
COA 4-(tert-Butyl)benzyl mercaptanStudy date
2023Publication
-Data no
258488Title
COA MethanolStudy date
2023Publication
-Data no
258489Title
COA Sodium methoxideStudy date
2023Publication
-Data no
258490Title
RAW MATERIAL SPECIFICATIONS FOR PYRIDABEN MANUFACTURINGStudy date
2023Publication
-Data no
258491Title
Justification of impurities in Pyridaben from a New Manufacturing SourceStudy date
24/06/2023Publication
-
IMTRADE ONQUIT 825 WG INSECTICIDE
Application Date
15-Sep-2023
Application Number
141326
Application Date
15-Sep-2023Application Number
141326Application Details
Product name
IMTRADE ONQUIT 825 WG INSECTICIDEProduct no
91867Applicant name
IMTRADE AUSTRALIA PTY LTDApplication purpose and description of use
Variation of product registration and label approval to extend uses into Almonds, Pome Fruit, Stone Fruit, Brassica Leafy Vegetables, Stalk & Stem Vegetables, Leafy Vegetables, Lettuce Fruiting Vegetables, Legume Vegetables, Strawberries, Sweetcorn, Cotton, Winter Pulse Crops & Summer Pulse Crops as per the Directions for Use.Active constituents
Active constituent name
88973 - CHLORANTRANILIPROLEDescription of data provided
Data no
258749Title
Investigation into the bio-efficacy of IMTRADE ONQUIT?? 825 WG INSECTICIDE to that of CORAGEN INSECTICIDE for the control of Diamondback Moth on Brussel Sprouts cv. Divino ??? One Trial, Langhorne Creek, South Australia.Study date
30/11/2021Publication
-Data no
258750Title
Investigation into the bio-equivalency of IMTRADE ONQUIT?? 825 WG INSECTICIDE to that of CORAGEN INSECTICIDE for the control of Lepidopteran Pests of Pumpkin cv. Queensland Blue ??? One Trial, Kalbar, Queensland.Study date
13/12/2021Publication
-Data no
258751Title
Investigation into the bio-equivalency of IMTRADE ONQUIT?? 825 WG INSECTICIDE to that of CORAGEN INSECTICIDE for the control of Lepidopteran Pests in Bean Vegetable Crop. ??? One Trial, Kalbar, Queensland.Study date
22/03/2021Publication
-Data no
258752Title
Investigation into the Bio-equivalency of IMTRADE ONQUIT?? 825 WG INSECTICIDE when compared to CORAGEN INSECTICIDE for the control of Cotton Earworm (Helicoverpa armigera) in Sweetcorn cv. ???Max??? (Zea mays) ??? One Trial, Kuitpo, South Australia.Study date
14/07/2022Publication
-Data no
258754Title
Investigation into the Bio-efficacy of IMTRADE ONQUIT?? 825 WG INSECTICIDE compared to ALTACOR INSECTICIDE for the control of Cotton Bollworm in Cotton cv. 746 ??? One Trial, Goondiwindi, Queensland.Study date
4/03/2022Publication
-Data no
258755Title
Investigation into the bio-equivalency of IMTRADE ONQUIT?? 825 WG INSECTICIDE for the control of Lepidopteran Pests in Cowpea cv. Ebony. ??? One Trial, South Kolan, QueenslandStudy date
24/11/2022Publication
-Data no
258756Title
Investigation into the bio-equivalency of IMTRADE ONQUIT 825 WG INSECTICIDE for the control of Cotton Bollworm in Cotton cv. Sicot 711RRF ??? One Trial, Forest Hill, Queensland.Study date
16/02/2023Publication
-Data no
258760Title
Comments to Support Efficacy and Host Crop Safety Data submitted.Study date
01/09/2023Publication
-Data no
258757Title
Investigation of the Host Crop Safety of IMTRADE ONQUIT?? 825 WG INSECTICIDE compared to CORAGEN INSECTICIDE in Greenhouse Lettuce cv. Iceberg. One Trial, Kwinana, Western AustraliaStudy date
14/07/2023Publication
-Data no
258758Title
Investigation of the Host Crop Safety of IMTRADE ONQUIT?? 825 WG INSECTICIDE compared to CORAGEN INSECTICIDE in Greenhouse Cucumber cv. Lebanese ??? One Trial, Kwinana, Western Australia.Study date
18/07/2023Publication
-Data no
258759Title
Investigation of the Host Crop Safety of IMTRADE ONQUIT?? 825 WG INSECTICIDE compared to CORAGEN INSECTICIDE when applied as a foliar treatment to Greenhouse Spinach cv. Viking ??? One Trial, Kwinana, Western Australia.Study date
31/08/2023Publication
-Data no
258753Title
Investigation into the Host Crop Safety of IMTRADE ONQUIT?? 825 WG INSECTICIDE to that of ALTACOR INSECTICIDE for the control of Lepidopteran Pests in a commercial Faba Bean cv. Samira crop. - One Trial, Saddleworth, South Australia.Study date
8/02/2023Publication
-Data no
258761Title
Imtrade ONQUIT?? 825 WG Insecticide - RLP_V1 pending 060923 MARKED COPYStudy date
06/09/2023Publication
-
ORALBUTE ORAL PASTE ANTI-INFLAMMATORY ANALGESIC FOR HORSES
Application Date
14-Sep-2023
Application Number
141004
Application Date
14-Sep-2023Application Number
141004Application Details
Product name
ORALBUTE ORAL PASTE ANTI-INFLAMMATORY ANALGESIC FOR HORSESProduct no
42362Applicant name
ABBEY LABORATORIES PTY LTDApplication purpose and description of use
Variation to add new pack sizes.
Suprelorin 4.7 mg
Application Date
14-Sep-2023
Application Number
141204
Application Date
14-Sep-2023Application Number
141204Application Details
Product name
Suprelorin 4.7 mgProduct no
56107Applicant name
VIRBAC (AUSTRALIA) PTY LTDApplication purpose and description of use
Variation of product registration and label approval to extend the product claimsActive constituents
Active constituent name
54980 - DESLORELIN AS DESLORELIN ACETATEActive constituent name
83365 - Deslorelin AcetateActive constituent name
83391 - Deslorelin AcetateActive constituent name
85819 - DESLORELIN ACETATEDescription of data provided
Data no
258259Title
Volume 1 - EU Part I SummaryStudy date
July 2023Publication
n/aData no
258261Title
Volume 3 - EU Part IV EfficacyStudy date
July 2023Publication
n/aData no
258270Title
bouchez-2021-70003-part1 - PKPD (Efficacy) - in catsStudy date
Mar 2021Publication
n/aData no
258271Title
bouchez-2021-70003-part2 - PKPD (Efficacy) - in catsStudy date
Mar 2021Publication
n/aData no
258379Title
F-416.010000-60003 Listings of Individual DataStudy date
2021Publication
n/aData no
258380Title
sarasola-2021_pharmacovigilance_classificationStudy date
2021Publication
n/aData no
258267Title
sarasola-2021-60003 - Efficacy - Field study in female dogsStudy date
Feb 2021Publication
n/aData no
258268Title
gontier-2021-60014 - Efficacy - Reproductive survey study in female dogsStudy date
Mar 2021Publication
n/aData no
258282Title
Bioscientia_Q_A,2022Study date
Feb 2022Publication
n/aData no
258283Title
Physiology and pathology of the estrous cycle of the bitchStudy date
2007Publication
56?? Congresso Internazionale Multisala SCIVACAuth party contact address
-Data no
258284Title
Fertility in Adult Bitches Previously Treated with a 4.7 mg Subcutaneous Deslorelin ImplantStudy date
2015Publication
Reprod Dom Anim 50, 965???971 (2015)Auth party contact address
-Data no
258381Title
Deslorelin implant as a treatment for temporary infertility in tomcatsStudy date
Apr 2019Publication
www.researchgate.net/publication/332233274Auth party contact address
-Data no
258382Title
Evaluation of genotoxicity testing of FDA approved large molecule therapeuticsStudy date
Jun 2014Publication
Regulatory Toxicology and Pharmacology 70 (2014) 87????????97Auth party contact address
-Data no
258383Title
Suppression of Fertility in Pre-pubertal Dogs and CatsStudy date
2014Publication
Reprod Dom Anim 49 (Suppl. 2), 21????????27Auth party contact address
-Data no
258384Title
GnRH and its receptor (GnRH-R) are expressed in the canine placenta and uterusStudy date
2015Publication
Theriogenology 84 (2015) 1482????????1489Auth party contact address
-Data no
258385Title
Pre-pubertal treatment with a GnRH agonist in bitches-Effect on the uterus and hormone receptor expressionStudy date
Aug 2018Publication
Reprod Dom Anim. 2018;53(Suppl. 3):103????????109Auth party contact address
-Data no
258386Title
Predominant Suppression of FSH????-immunoreactivity after Long-Term Treatment of Intact and Castrate Adult Male Rats with the GnRH Agonist DeslorelinStudy date
May 2012Publication
Neuroendocrinol. 2012 May ; 24(5): 737????????747Auth party contact address
-Data no
258387Title
Body Conformation, Diet, and Risk of Breast Cancer in Pet Dogs: A Case-Control StudyStudy date
1991Publication
American Journal of Epidemiology, Vol 133, No 7, pg 694-703Auth party contact address
-Data no
258388Title
Long-term risks and benefits of early-age gonadectomy in catsStudy date
Feb 2004Publication
JAVMA, Vol 224, No. 3,pg 372-379Auth party contact address
-Data no
258389Title
Prepubertal gonadectomy in the domestic feline: Effects on skeletal, physical, and behavioural developmentStudy date
1993Publication
Official Journal of the American College of Veterinary Anesthesiologists, Vol 22, No. 5, pg 401Auth party contact address
-Data no
258390Title
Implications of Early Neutering in the Dog and CatStudy date
Feb 1995Publication
Seminars in Veterinary Medicine and Surgery (Small Animal), Vol 10, No 1 (February), 1995: pp 8-12Auth party contact address
-Data no
258391Title
Product Monograph SuprefactStudy date
Aug 2015Publication
Sanofi Canada (yumpu.com)Auth party contact address
-Data no
258392Title
Suprelorin EPAR Scientific DiscussionStudy date
2007Publication
https://www.ema.europa.eu/en/documents/scientific-discussion/suprelorin-epar-scientific-discussion_en.pdfAuth party contact address
-Data no
258393Title
Interactions between hormones and epilepsyStudy date
Feb 2015Publication
Seizure 28 (2015) 3????????11Auth party contact address
-Data no
258394Title
Mammary Neoplasia in a Closed Beagle ColonyStudy date
Aug 1976Publication
Cancer Research 36, 2740-2743Auth party contact address
-Data no
258395Title
Genotoxicity assessment of peptide/ protein-related biotherapeutics: points to consider before testingStudy date
2016Publication
Mutagenesis, 2016, 31, 375????????384Auth party contact address
-Data no
258396Title
Kisspeptin signalling and its roles in humansStudy date
2015Publication
Singapore Med J 2015; 56(12): 649-656Auth party contact address
-Data no
258397Title
Testosterone Acts Directly at the Pituitary to Regulate Gonadotropin-Releasing Hormone-Induced Calcium Signals in Male Rat GonadotropesStudy date
1997Publication
Endocrinology, Vol 138, No 8, pg 3314-3319Auth party contact address
-Data no
258398Title
Use of a GnRH analogue implant to produce reversible longterm suppression of reproductive function in male and female domestic dogsStudy date
2001Publication
Journal of Reproduction and Fertility supplement 57, 255-261.(2001)Auth party contact address
-Data no
258399Title
A review of advances in the use of the GnRH agonist deslorelin in control of reproductionStudy date
2006Publication
Theriogenology 66 (2006) 1507????????1512Auth party contact address
-Data no
258400Title
Sex and Hormonal influences on Seizures and EpilepsyStudy date
Feb 2013Publication
Horm Behav. 2013 February ; 63(2): 267????????277Auth party contact address
-Data no
258401Title
Male contraceptive potential of nafarelin acetate assessed in the dogStudy date
1984Publication
LHRH and its Analogs, pg 61- 75Auth party contact address
-Data no
258402Title
Use of potent LHRH analogues for chronic contraception and pregnancy termination in dogsStudy date
1989Publication
J. Reprod. Fert., Suppl. 39 (1989), 175-187Auth party contact address
-Data no
258403Title
The Epiphyseal Plate: Physiology, Anatomy, and TraumaStudy date
Jul 2009Publication
CompendiumVet.com, July 2009, E1-12Auth party contact address
-Data no
258404Title
Suppression of the oestrus responses of bitches to the GnRH analogue deslorelin by progestinStudy date
2001Publication
J Reprod Fertil Suppl . 2001;57:263-268.Auth party contact address
-Data no
258275Title
Acute Oral Toxicity Study in RatsStudy date
Dec 2015Publication
n/aData no
258276Title
Acute SC Toxicity Study in RatsStudy date
Dec 2015Publication
-Data no
258349Title
Deslorelin Implants in Pre-pubertal Female Dogs: Short- and Long-Term Effects on the Genital TractStudy date
2014Publication
Reprod Dom Anim 49, 297????????301Auth party contact address
-Data no
258350Title
Non-surgical contraception in male dogs and catsStudy date
2015Publication
Acta Sci. Pol. Zootechnica 14(1) 2015, 3????????14Auth party contact address
-Data no
258351Title
Delayed physeal closure associated with castration in catsStudy date
1991Publication
Journal of Small Animal Practice (1991) 32, 326-328Auth party contact address
-Data no
258352Title
Long-term reversible suppression of oestrus in bitches with nafarelin acetate, a potent LHRH agonistStudy date
1985Publication
J. Reprod. Fert. (1985), 74; 389-397Auth party contact address
-Data no
258353Title
GnRH-agonist implantation of prepubertal male cats affects their reproductive performance and testicular LH receptor and FSH receptor expressionStudy date
2016Publication
Theriogenology 85 (2016) 841????????848Auth party contact address
-Data no
258354Title
GnRH-agonist implants suppress reproductive function and affects ovarian LHR and FSHR expression in prepubertal female catsStudy date
2017Publication
Theriogenology 87 (2017) 250????????258Auth party contact address
-Data no
258355Title
A Meta-Analysis of Studies of Treatments for Feline Urine SprayingStudy date
Apr 2011Publication
Plos ONE; April 2011, Volume 6, Issue 4, e18448Auth party contact address
-Data no
258356Title
Pharmacodynamics and pharmacokinetics of a sustained release implant of deslorelin in companion animals.Study date
2012Publication
n/aData no
258357Title
Efficacy of deslorelin implants as the first line treatment of spayed bitches with clinical signs of urinary incontinenceStudy date
2013Publication
n/aData no
258358Title
Characterization of 12 GnRH peptide agonists - a kinetic perspectiveStudy date
2016Publication
British Journal of Pharmacology, 2016; 173:128-141Auth party contact address
-Data no
258359Title
A Population of Non-Luteinising Hormone - Non- Adrenocorticotrophic Hormone-Positive Cells in the Male Rat Anterior Pituitary Responds Mitotically to Both Gonadectomy and AdrenalectomyStudy date
2006Publication
Journal of Neuroendocrinology 18, 655????????661, 2006Auth party contact address
-Data no
258360Title
Reversible suppression of sexual activity in tomcats with deslorelin implantStudy date
Sep 2012Publication
Theriogenology, Volume 78, Issue 4, Pages 848-857Auth party contact address
-Data no
258361Title
Azoospermia with variable testicular histology after 7 months of treatment with a deslorelin implant in tomsStudy date
2015Publication
Theriogenology 83 (2015) 1188????????1193Auth party contact address
-Data no
258362Title
Effectiveness of Deslorelin Acetate for the suppression of heat in the bitchStudy date
2010Publication
n/aData no
258363Title
The use of deslorelin acetate (Suprelorin) in companion animal medicineStudy date
2012Publication
Schweiz Arch Tierheilkd. 2012Auth party contact address
-Data no
258364Title
Genetics of the development and function of adrenal cortexStudy date
2001Publication
Rev Endocr Metab Disord. (2001), 2: 245-252Auth party contact address
-Data no
258365Title
Factors influencing the incidence and prognosis of canine rnammary tumorsStudy date
2000Publication
Journal of Small Animal Practice (2000) 41, 287-291Auth party contact address
-Data no
258366Title
Effect of neutering and breed on femoral and tibial physeal closure times in male and female domestic catsStudy date
Sep 2013Publication
Journal of Feline Medicine and Surgery 2014, Vol 16(2) 149???????? 156Auth party contact address
-Data no
258367Title
Study #1380B-60-98-00 Efficacy of Deslorelin in Delaying Onset of Sexual Maturity in Male and Female Cats.Study date
Aug 1999Publication
n/aData no
258368Title
The effect of GnRH analogs on urinary incontinence after ablation of the ovaries in dogsStudy date
2003Publication
Theriogenology 60 (2003) 1207????????1216Auth party contact address
-Data no
258369Title
Urinary Incontinence in the Bitch: An UpdateStudy date
2014Publication
Reprod Dom Anim 49 (Suppl. 2), 75????????80Data no
258370Title
Long-Term-Release GnRH Agonists Postpone Puberty in Domestic CatsStudy date
2012Publication
Reprod Dom Anim doi: 10.1111/j.1439-0531.2012.01994.xAuth party contact address
-Data no
258371Title
Duration of control of reproductive function following administration of a single 4.7 mg Deslorelin implant in adult tomcats and effect on testicular histologyStudy date
Mar 2011Publication
n/aData no
258372Title
Early-age neutering in dogs and cats: advantages and disadvantagesStudy date
Mar 2017Publication
Rev. Bras. Reprod. Anim., Belo Horizonte, v.41, n.1, p.130-132Auth party contact address
-Data no
258373Title
Length of efficacy and effect of implant location in adult tom cats treated with a 9.4 mg deslorelin subcutaneous implantStudy date
2019Publication
Journal of Feline Medicine and Surgery 2019, Vol. 21(6) 507???????? 519Auth party contact address
-Data no
258374Title
The effect of prepuberal and postpuberal gonadectomy on radial physeal closure in male and female domestic catsStudy date
1997Publication
Vet. Radiology & Ultrasound, Vol 38, No. 1, pg 42-47Auth party contact address
-Data no
258375Title
Expert opinion on release of active from Suprelorin ImplantsStudy date
2006Publication
n/aData no
258376Title
Treatment with a subcutaneous GnRH agonist containing controlled release device reversibly prevents puberty in bitchesStudy date
2006Publication
Theriogenology 66 (2006) 1651????????1654Auth party contact address
-Data no
258377Title
Kisspeptin Neurons in the Infundibular Nucleus of Ovariectomized Cats and Dogs Exhibit Unique Anatomical and Neurochemical CharacteristicsStudy date
Dec 2020Publication
Frontiers in Neuroscience, Dec 2020, Vol 14, Article 598707Auth party contact address
-Data no
258378Title
Gonadectomy in immature dogs: Effects on skeletal, physical, and behavioral developmentStudy date
1991Publication
JAYMA, Vol 198, No. 7, pg 1193-1203Auth party contact address
-Data no
258287Title
Effect of GnRH analogs in postnatal domestic catsStudy date
Mar 2014Publication
Theriogenology 82 (2014) 138???143Auth party contact address
-Data no
258288Title
The Endocrine brain and Clinical Tests of Its FunctionsStudy date
1986Publication
Clinical Endocrinology of Companion AnimalsAuth party contact address
-Data no
258289Title
Age and Sex Difference in Serum and Pituitary Thyrotropin Concentrations in the RatStudy date
Aug 1983Publication
Experimental Gerontology, Vol. 19, pp. 1-6, 1984Auth party contact address
-Data no
258290Title
Effect of Fertirelin Acetate or Buserelln on Conception Rate at First or second Insemination in Lactating Dairy CowsStudy date
Oct 1989Publication
1990 J Dairy Sci 73: 633-638Auth party contact address
-Data no
258291Title
Reproductive cycles of the domestic bitchStudy date
Aug 2010Publication
Anim. Reprod. Sci. (2010), doi:10.1016/j.anireprosci.2010.08.028Auth party contact address
-Data no
258292Title
Assessing the Efficacy and Safety of Deslorelin Acetate Implants in Alternative Placement SitesStudy date
Oct 2017Publication
Journal of Zoo and Wildlife Medicine 49(1): 1???8, 2018Data no
258293Title
CVMP advisory notice firbrosarcomasStudy date
2003Publication
n/aAuth party contact address
-Data no
258294Title
Reproductive endocrinology of the dog, effects of medical and surgical interventionStudy date
2011Publication
n/aData no
258295Title
Interval between Removal of a 4.7 mg Deslorelin Implant after a 3, 6, and 9-Mth Treatment and Restoration of Testicular Function in TomcatsStudy date
Aug 2020Publication
Animals 2020, 10, 1559Auth party contact address
-Data no
258296Title
Investigations of the Carcinogenicity of the LH-RH Analog Buserelin in RatsStudy date
1987Publication
Fundamental and Applied Toxicology 9, 738-752Auth party contact address
-Data no
258297Title
Gonadotropin-Releasing Hormone (GnRH) Agonist Implants for Male Dog Fertility Suppression: A Review of Mode of Action, Efficacy, Safety, and UsesStudy date
Aug 2020Publication
Frontiers in Vet Science, Vol 7, Art 483Auth party contact address
-Data no
258298Title
ECHA DeslorelinStudy date
Jul 2019Publication
ECHAAuth party contact address
-Data no
258299Title
ema-epmar-alarelinStudy date
Jan 2018Publication
n/aAuth party contact address
-Data no
258300Title
ema-azaglynafarelin-summary reportStudy date
Feb 2002Publication
n/aAuth party contact address
-Data no
258301Title
ema-buserelin-summary reportStudy date
1995Publication
n/aAuth party contact address
-Data no
258302Title
ema-deslorelin-acetate-summary reportStudy date
2002Publication
n/aAuth party contact address
-Data no
258303Title
ema-fertirelin-summary reportStudy date
1996Publication
n/aAuth party contact address
-Data no
258304Title
ema-lecirelin-summary reportStudy date
1997Publication
n/aAuth party contact address
-Data no
258305Title
ema-peforelin-summary reportStudy date
2006Publication
n/aAuth party contact address
-Data no
258306Title
ema-epmar-triptorelinStudy date
2014Publication
n/aAuth party contact address
-Data no
258307Title
Effects of long-term release GnRH agonist - deslorelin - on testicular HSP expression, accessory sex glands and testicular functions in adult male ratsStudy date
May 2019Publication
10.1016/j.theriogenology.2019.05.016Auth party contact address
-Data no
258308Title
Re-establishment of sperm quality after long-term deslorelin suppression in tomcatsStudy date
Jun 2018Publication
Animal Reproduction Science 195 (2018) 302????????308Auth party contact address
-Data no
258309Title
Postponement of canine puberty by neonatal administration of a long term release GnRH superagonistStudy date
Jun 2018Publication
Theriogenology 118 (2018) 190e195Auth party contact address
-Data no
258310Title
Medical Treatment for Pyometra in DogsStudy date
2014Publication
Reprod Dom Anim 49 (Suppl. 2), 28????????32Auth party contact address
-Data no
258311Title
Agonist-induced internalization and downregulation of gonadotropin-releasing hormone receptorsStudy date
Jul 2009Publication
Am J Physiol Cell Physiol 297: C591????????C600Auth party contact address
-Data no
258312Title
Clinical Use of GnRH Agonists in Canine and Feline SpeciesStudy date
Sep 2010Publication
Reprod Dom Anim doi: 10.1111/j.1439-0531Auth party contact address
-Data no
258313Title
Postponement of puberty using GnRH agonists implants in bitches of different breedsStudy date
2012Publication
n/aAuth party contact address
-Data no
258314Title
A review of Suprelorin (deslorelin) studies in catsStudy date
2015Publication
Journal of Feline Medicine and Surgery (2015) 17, 766????????771Auth party contact address
-Data no
258315Title
Synthetic Analogs of Luteinizing Hormone Releasing Hormone (LH-RH) Substituted in Position 6 and 10Study date
Jul 1974Publication
Biochemical and Biophysical Research Communications, Vol. 60, No 1, 406-413Auth party contact address
-Data no
258316Title
Personal Statement 416.01 Suprelorin - Repeated use in CatsStudy date
Mar 2022Publication
n/aData no
258317Title
Contraceptive implants used by cat breeders in France: a study of 140 purebred catsStudy date
2020Publication
Journal of Feline Medicine and Surgery 2020, Vol. 22(10) 984???????? 992Auth party contact address
-Data no
258318Title
Clinical efficacy of a GnRH-agonist implant containing 4.7 mg deslorelin, Suprelorin, regarding suppression of reproductive function in tomcatsStudy date
2011Publication
Theriogenology 75 (2011) 803????????810Auth party contact address
-Data no
258319Title
Treatment with Suprelorin in a pregnant catStudy date
Mar 2013Publication
Journal of Feline Medicine and Surgery 2013 15: 357Auth party contact address
-Data no
258320Title
Treatment of queens in estrus and after estrus with a GnRH-agonist implant containing 4.7 mg deslorelin; hormonal response, duration of efficacy, and reversibilityStudy date
Mar 2013Publication
Theriogenology 79 (2013) 640????????646Auth party contact address
-Data no
258321Title
Basal testosterone concentrations after the application of a slow-release GnRH agonist implant are associated with a loss of response to buserelin, a short-term GnRH agonist, in the tom catStudy date
Mar 2013Publication
Theriogenology 80 (2013) 65????????69Auth party contact address
-Data no
258322Title
Reversibility of germinative and endocrine testicular function after long-term contraception with a GnRH-agonist implant in the tom - a follow-up studyStudy date
Jan 2014Publication
Theriogenology Volume 81, Issue 7, Pages 941-946Auth party contact address
-Data no
258323Title
Suppression of Fertility in Adult CatsStudy date
2014Publication
Reprod Dom Anim 49 (Suppl. 2), 33????????40Auth party contact address
-Data no
258324Title
Long-term effects of GnRH agonists on fertility and behaviourStudy date
2017Publication
Reprod Dom Anim 2017; 52 (Suppl. 2): 336????????347Auth party contact address
-Data no
258325Title
Effect of deslorelin on testicular function, serum dihydrotestosterone and oestradiol concentrations during and after suppression of sexual activity in tom catsStudy date
Nov 2015Publication
Journal of Feline Medicine and Surgery ??????1???????? 9, 10.1177Auth party contact address
-Data no
258326Title
The Anterior Pituitary Gland in Tumor-Bearing RatsStudy date
1964Publication
n/aAuth party contact address
-Data no
258327Title
A literature review on the welfare implications of gonadectomy of dogsStudy date
May 2017Publication
JAVMA , Vol 250, No. 10, pg 155-1166Auth party contact address
-Data no
258328Title
Prepuberal Gonadectomy - Early-Age Neutering of Dogs and CatsStudy date
Apr 2000Publication
International Veterinary Information ServiceAuth party contact address
-Data no
258329Title
Long-term outcome of gonadectomy performed at an early age or traditional age in dogsStudy date
2001Publication
JAVMA, Vol 218, No. 2, January 15, 2001Auth party contact address
-Data no
258330Title
Breed Variations in the Incidence of Pyometra and Mammary Tumours in Swedish DogsStudy date
2012Publication
Reprod Dom Anim 47 (Suppl. 6), 347????????350Auth party contact address
-Data no
258331Title
Sexual Differentiation and Normal Anatomy of the Tom CatStudy date
2001Publication
Canine and Feline Theriogenology, Section IV, Ch 36Auth party contact address
-Data no
258332Title
Testosterone and Androstenedione Profiles in the Blood of Domestic Tom-CatsStudy date
Dec 1983Publication
Animal Reproduction Science, 7 (1984) 363-375Auth party contact address
-Data no
258333Title
Plasma Deslorelin in Implanted DogsStudy date
1998Publication
n/aData no
258334Title
Use of a new drug delivery formulation of the gonadotrophin-releasing hormone analogue Deslorelin for reversible long-term contraception in male dogsStudy date
2003Publication
Reproduction, Fertility and Development, 2003, 15, 317-322Auth party contact address
-Data no
258335Title
Gonadotropin-Releasing Hormone Analog Design. Structure-Function Studies Toward the Development of Agonists and Antagonists: Rationale and PerspectiveStudy date
Feb 1986Publication
Endocrine Reviews, Vol. 7, No. 1, 44-66Auth party contact address
-Data no
258336Title
Clinical and Endocrine Short-Term Effects of GnRH Analogue Deslorelin in Prepubertal Bitches: Does A - Flare-up - Occur?Study date
2013Publication
Kafkas Univ Vet Fak Derg, DOI: 10.9775/kvfd.2012.7716Auth party contact address
-Data no
258337Title
Clinical use of deslorelin implants for the long-term contraception in prepubertal bitches: Effects on epiphyseal closure, body development, and time to pubertyStudy date
Dec 2014Publication
Theriogenology 83 (2015) 1147????????1153Auth party contact address
-Data no
258338Title
Expression of GnRH receptor in the canine corpus luteum, and luteal function following deslorelin acetate-induced puberty delayStudy date
Jun 2017Publication
Reprod Dom Anim. 2017, 1????????9Auth party contact address
-Data no
258339Title
Review of Growth Plate Closure Compared with Age at Sexual Maturity and Lifespan in Laboratory AnimalsStudy date
Sep 2002Publication
American Association for Laboratory Animal Science, Vol 41, No. 5, 21-26Auth party contact address
-Data no
258340Title
TGF-b superfamily members and ovarian follicle developmentStudy date
2006Publication
Reproduction (2006) 132 191????????206Auth party contact address
-Data no
258341Title
The use of Suprelorin for postponement of oestrus in the bitchStudy date
2013Publication
n/aData no
258342Title
Gonadotropin-releasing hormone analogs: Understanding advantages and limitationsStudy date
2014Publication
J Hum Reprod Sci, 2014; 7: 170-174Auth party contact address
-Data no
258343Title
Determining the optimal age for gonadectomy of dogs and catsStudy date
Dec 2007Publication
JAVMA, Vol 231, No. 11; 1665-1675Auth party contact address
-Data no
258344Title
Penile Spines of the Domestic Cat: Their Endocrine-Behaviour RelationsStudy date
1987Publication
Anat, Rec., 157: 71-78.Auth party contact address
-Data no
258345Title
Early age altering of kittensStudy date
2006Publication
n/aData no
258346Title
Clinical Use of Deslorelin (GnRH agonist) in Companion Animals: A ReviewStudy date
2014Publication
Reprod Dom Anim 49 (Suppl. 4), 64????????71Auth party contact address
-Data no
258347Title
Results of GnRH Agonist Implants in Oestrous Induction and Oestrous Suppression in Bitches and QueensStudy date
2012Publication
Reprod Dom Anim 47 (Suppl. 6), 393????????397Auth party contact address
-Data no
258280Title
Gonadotropin-releasing hormone (GnRH) analogs: relationship between their structure, proteolytic inactivation and pharmacokinetics in ratsStudy date
Feb 1991Publication
Regulatory Peptides, 33 (1991) 299-311Auth party contact address
-Data no
258269Title
delprat-alies-2021-40003 - TAS (Efficacy) - catsStudy date
Jan 2021Publication
n/aData no
258285Title
Braun, 2021-60006-protocolStudy date
Oct 2019Publication
n/aData no
258286Title
Braun, 2021-bioanalytical-reportStudy date
Nov 2021Publication
n/aData no
258272Title
braun-2021-60005 - TAS_Efficacy - Field study in catsStudy date
Mar 2021Publication
n/aData no
258273Title
pellet-2021-60011 - PK study on field study catsStudy date
Apr 2021Publication
n/aData no
258274Title
Braun-2022-60006 - TAS_Efficacy - Field study in cats (after Study 60005)Study date
Feb 2022Publication
n/aData no
258262Title
davis-2017-30001 - TAS - spayed female dogsStudy date
Feb 2017Publication
n/aData no
258263Title
warneke-2021-60001-part1 - TAS spayed female dogsStudy date
2021Publication
n/aData no
258264Title
warneke-2021-60001-part2 - TAS spayed female dogsStudy date
2021Publication
n/aData no
258265Title
warneke-2021-60001-part3 - TAS spayed female dogsStudy date
2021Publication
n/aData no
258266Title
warneke-2021-60001-part4 - TAS spayed female dogsStudy date
2021Publication
n/aData no
258260Title
Volume 2 - EU Part III SafetyStudy date
July 2023Publication
n/aData no
258281Title
Bioscientia_accreditation_status, 2020Study date
July 2020Publication
n/aData no
258257Title
Cover LetterStudy date
Aug 2023Publication
n/aData no
258258Title
Summary of studies and literatureStudy date
Aug 2023Publication
n/aData no
258277Title
Kisspeptin receptor agonist has therapeutic potential for female reproductive disordersStudy date
Dec 2020Publication
Journal Clinical Investigation - V130 - No.12Auth party contact address
-Data no
258278Title
Ovarian activity reversibility after the use of deslorelin acetate as a short-term contraceptive in domestic queensStudy date
Mar 2012Publication
Theriogenology 78 (2012) 817???822Auth party contact address
-Data no
258279Title
Urinary Incontinence in Spayed Bitches: New Insights into the Pathophysiology and Options for Medical TreatmentStudy date
2009Publication
Reprod Dom Anim 44 (Suppl. 2), 190???192 (2009)Auth party contact address
-Data no
258348Title
Suppression of Fertility in Adult DogsStudy date
2014Publication
Reprod Dom Anim 49 (Suppl. 2), 58????????63Auth party contact address
-
NOVAGUARD FLUPROPANATE 745 HERBICIDE
Application Date
14-Sep-2023
Application Number
141264
Application Date
14-Sep-2023Application Number
141264Application Details
Product name
NOVAGUARD FLUPROPANATE 745 HERBICIDEProduct no
68732Applicant name
NOVAGUARD PTY LTDApplication purpose and description of use
Variation of product registration and label approval to update the withholding period.Active constituents
Active constituent name
53930 - FLUPROPANATE-SODIUMDescription of data provided
Data no
258527Title
Executive SummaryStudy date
1 September 2023Publication
Not PublishedData no
258528Title
RE: INVITATION TO SUBMIT ITEM 13 APPLICATIONStudy date
31 July 2023Publication
Not Published
Agro-Essence AmmoSul Herbicide Adjuvant
Application Date
14-Sep-2023
Application Number
141331
Application Date
14-Sep-2023Application Number
141331Application Details
Product name
Agro-Essence AmmoSul Herbicide AdjuvantProduct no
94042Applicant name
AGRO-ALLIANCE (AUSTRALIA) PTY LTDApplication purpose and description of use
Registration of a 980 g/kg AMMONIUM SULPHATE granular product to be used with glyphosate-based herbicides to minimise antagonism when tank mixed with flowable herbicides and to improve performance under adverse environmental conditions.Reference Details
66968 - TRIO AMMONIUM SULPHATE HERBICIDE ADJUVANT
Agro-Essence Flupropanate 745 Herbicide
Application Date
14-Sep-2023
Application Number
141333
Application Date
14-Sep-2023Application Number
141333Application Details
Product name
Agro-Essence Flupropanate 745 HerbicideProduct no
94044Applicant name
AGRO-ALLIANCE (AUSTRALIA) PTY LTDApplication purpose and description of use
Registration of a 745 g/L FLUPROPANATE present as the sodium salt, soluble concentrate (SL) formulation, a component of Integrated Management of Serrated Tussock, Giant Parramatta Grass, Giant Rat’s Tail Grass, Chilean Needle Grass, African Lovegrass and Certain Grasses,Active constituents
Active constituent name
67742 - FLUPROPANATE-SODIUMReference Details
92793 - Submarino Flupropanate 745 Herbicide
Q-STAR MULTI COMBINATION DRENCH FOR SHEEP
Application Date
13-Sep-2023
Application Number
141273
Application Date
13-Sep-2023Application Number
141273Application Details
Product name
Q-STAR MULTI COMBINATION DRENCH FOR SHEEPProduct no
94025Applicant name
VETPHARM LABORATORIES IP PTY LTDApplication purpose and description of use
Registration of a 40 g/L levamisole hydrochloride, 37.5 g/L closantel, 25 g/L albendazole and 1.0 g/L abamectin oral drench product for the treatment and control in sheep of susceptible gastrointestinal roundworms, lungworm, tapeworms, mature and late immature liver fluke, nasal bot and itch mite.Active constituents
Active constituent name
84023 - LEVAMISOLE HYDROCHLORIDEActive constituent name
92029 - ClosantelActive constituent name
84847 - ALBENDAZOLEActive constituent name
82843 - ABAMECTINDescription of data provided
Data no
258534Title
Product specificationsStudy date
2023Publication
N/AAuth party contact address
7/20 St Johns Avenue GORDON AustraliaReference Details
56573 - Q-DRENCH MULTI-COMBINATION DRENCH FOR SHEEP
Requiem Ever-Ready Termite Bait Disk Sacks
Application Date
13-Sep-2023
Application Number
141314
Application Date
13-Sep-2023Application Number
141314Application Details
Product name
Requiem Ever-Ready Termite Bait Disk SacksProduct no
90707Applicant name
ENSYSTEX AUSTRALASIA PTY LTDApplication purpose and description of use
Variation to product and label approval to amend the General Instructions and update to the Labelling Code.Active constituents
Active constituent name
54270 - CHLORFLUAZURONDescription of data provided
Data no
258720Title
Requiem Ever-Ready Termite Disk Sacks label amendmentStudy date
30/08/2023Publication
-Data no
258721Title
Efficacy and crop safety review for Requiem Ever-Ready Termite BaitStudy date
15/07/2021Publication
-
Flonicamid Technical
Application Date
13-Sep-2023
Application Number
141316
Application Date
13-Sep-2023Application Number
141316Application Details
Product name
Flonicamid TechnicalActive name
Flonicamid TechnicalApplicant name
Shandong Rainbow International Co LtdApplication purpose and description of use
Approval of Flonicamid TCl for use in agricultural chemical products.Description of data provided
Data no
258745Title
DocStudy date
August 29, 2023Publication
-Data no
258746Title
The Statement of Batch Size of Flonicamid Technical in 5-Batch ReportStudy date
01/09/2023Publication
-Data no
258747Title
CoAStudy date
JUL. 20, 2023Publication
-Data no
258748Title
Determination of Active Content and Impurity Profile of FlonicamidStudy date
24 Dec 2019Publication
-Data no
258742Title
Chemistry &Manufacturing DossierStudy date
05/09/2023Publication
-Data no
258743Title
MANUFACTURE PROCESS OF FLONICAMID TECHNICALStudy date
01/09/2023Publication
-Data no
258744Title
THE JUSTIFICATION OF IMPURITIES OF FLONICAMID TECHNICALStudy date
01/09/2023Publication
-
RICHGRO ANT KILLA
Application Date
13-Sep-2023
Application Number
141327
Application Date
13-Sep-2023Application Number
141327Application Details
Product name
RICHGRO ANT KILLAProduct no
59354Applicant name
A. RICHARDS PTY LTDApplication purpose and description of use
Variation of label approval to extend the use to include the control of slaters and millipedes.Active constituents
Active constituent name
44362 - BIFENTHRINActive constituent name
55353 - BIFENTHRINDescription of data provided
Data no
258762Title
59354 AA letterStudy date
7 September 2023Publication
-Reference Details
67326 - RICHGRO SLATER AND MILLIPEDE KILLA
Conquest Carbendazim 500 SC Fungicide
Application Date
13-Sep-2023
Application Number
141328
Application Date
13-Sep-2023Application Number
141328Application Details
Product name
Conquest Carbendazim 500 SC FungicideProduct no
93112Applicant name
CONQUEST CROP PROTECTION PTY LTDApplication purpose and description of use
Variation of product registration and a pack sizeActive constituents
Active constituent name
52720 - CARBENDAZIMActive constituent name
58049 - CARBENDAZIMActive constituent name
64891 - CARBENDAZIMDescription of data provided
Data no
258763Title
Cover LetterStudy date
September 2023Publication
-Reference Details
52878 - HOWZAT SC FUNGICIDE
86237 - Smart Carbendazim 500 SC Fungicide
92162 - Guardazim Fungicide
CAMPBELL CHEERS 720 WEATHERSHIELD FUNGICIDE
Application Date
12-Sep-2023
Application Number
141139
Application Date
12-Sep-2023Application Number
141139Application Details
Product name
CAMPBELL CHEERS 720 WEATHERSHIELD FUNGICIDEProduct no
63122Applicant name
COLIN CAMPBELL (CHEMICALS) PTY LTDApplication purpose and description of use
Variation of label approval to alter details for peanuts and bananasActive constituents
Active constituent name
44206 - CHLOROTHALONILDescription of data provided
Data no
257754Title
Revised DFU for Campbell Cheers 720 Weathershield FungicideStudy date
21 August 2023Publication
-Reference Details
52518 - SIPCAM ECHO 720 FUNGICIDE
CYLAP RCD VACCINE
Application Date
12-Sep-2023
Application Number
141175
Application Date
12-Sep-2023Application Number
141175Application Details
Product name
CYLAP RCD VACCINEProduct no
49682Applicant name
ZOETIS AUSTRALIA PTY LTDApplication purpose and description of use
Variation of product registration to address the non-standard condition.Active constituents
Active constituent name
84424 - INACTIVATED RABBIT CALICIVIRUS DISEASE VIRUSDescription of data provided
Data no
258027Title
Stability reportStudy date
24 May 2023Publication
n/a
DRONTAL ALLWORMER FOR SMALL DOGS & PUPPIES
Application Date
12-Sep-2023
Application Number
141177
Application Date
12-Sep-2023Application Number
141177Application Details
Product name
DRONTAL ALLWORMER FOR SMALL DOGS & PUPPIESProduct no
35825Applicant name
VETOQUINOL AUSTRALIA PTY LTDApplication purpose and description of use
Variation of product label approval to Vet labelling guidelines and update sites of manufacture.Active constituents
Active constituent name
81958 - PRAZIQUANTEL
CONAN STICKS 720 SC FUNGICIDE
Application Date
12-Sep-2023
Application Number
141269
Application Date
12-Sep-2023Application Number
141269Application Details
Product name
CONAN STICKS 720 SC FUNGICIDEProduct no
68458Applicant name
UPL AUSTRALIA PTY LTDApplication purpose and description of use
Variation of product registration and label approval to update direction for use particularsActive constituents
Active constituent name
55287 - CHLOROTHALONILActive constituent name
64784 - CHLOROTHALONILDescription of data provided
Data no
258532Title
Conan 720 item 12Study date
2023Publication
-
CropSure Diuron 900WG Herbicide
Application Date
12-Sep-2023
Application Number
141284
Application Date
12-Sep-2023Application Number
141284Application Details
Product name
CropSure Diuron 900WG HerbicideProduct no
94026Applicant name
CROPSURE PTY LTDApplication purpose and description of use
Registration of a 900g/kg Diuron Water Dispersible granule product for the control of weeds in asparagus, bananas, cereals, cotton, lucerne, lupins, pulse crops and sugar cane as specified in the directions for use table.Active constituents
Active constituent name
64374 - DIURONReference Details
89599 - Daywalker 900 Herbicide
IMTRADE DIQUAT 200 NON-RESIDUAL HERBICIDE
Application Date
12-Sep-2023
Application Number
141286
Application Date
12-Sep-2023Application Number
141286Application Details
Product name
IMTRADE DIQUAT 200 NON-RESIDUAL HERBICIDEProduct no
58411Applicant name
IMTRADE AUSTRALIA PTY LTDApplication purpose and description of use
Variation of product registration and label approval to amend current registered Pack Size Range of 5L-110L to be 5L-1000L to allow for greater marketability of product.Active constituents
Active constituent name
56655 - DIQUAT DIBROMIDE MANUFACTURING CONCENTRATEDescription of data provided
Data no
258683Title
Imtrade Diquat 200 Non-Residual Herbicide - RLP_V1 pending 010923 MARKED COPY.Study date
4/9/23Publication
-
Chlorantraniliprole
Application Date
12-Sep-2023
Application Number
141294
Application Date
12-Sep-2023Application Number
141294Application Details
Product name
ChlorantraniliproleActive name
ChlorantraniliproleApplicant name
Sino-Agri Leading Biosciences Co., Ltd.Application purpose and description of use
Approval of Chlorantraniliprole for use in agricultural agricultural chemical products.Description of data provided
Data no
258548Title
Five Batch Analysis Of Chlorantraniliprole Technical ??? Relative Impurity Analysis.Study date
24 August 2020Publication
Not PublishedData no
258547Title
Five Batch Analysis Of Chlorantraniliprole TechnicalStudy date
24 August 2020Publication
Not PublishedData no
258545Title
Manufacturing Process and Synthesis Pathway and Formation of ImpurityStudy date
23 August 2023Publication
Not PublishedData no
258546Title
Declaration of CompositionStudy date
23 August 2023Publication
Not PublishedData no
258549Title
Chlorantraniliprole TechnicalStudy date
1 September 2023Publication
Not PublishedData no
258544Title
Executive SummaryStudy date
1 September 2023Publication
Not Published
AquaHealth Algae Guard
Application Date
12-Sep-2023
Application Number
141296
Application Date
12-Sep-2023Application Number
141296Application Details
Product name
AquaHealth Algae GuardApplicant name
WATERCO LIMITEDApplication purpose and description of use
Registration of a solution of 685g/L Poly[oxyethylene(dimethylimino)ethylene(dimethylimino)ethylene for the control of algae in swimming pools.
Flumioxazin
Application Date
12-Sep-2023
Application Number
141298
Application Date
12-Sep-2023Application Number
141298Application Details
Product name
FlumioxazinActive name
FlumioxazinApplicant name
SHANDONG JINGBO AGROCHEMICALS TECHNOLOGY CO., LTD.Application purpose and description of use
Approval of Flumioxazin for use in agricultural chemical products.Description of data provided
Data no
258675Title
Five Batch Analysis Of Flumioxazin TechnicalStudy date
21 December 2022Publication
Not PublishedData no
258673Title
Technical Report Industrial Synthesis And Formation Of Impurities FlumioxazinStudy date
August 2023Publication
Not PublishedData no
258674Title
Declaration of CompositionStudy date
21 August 2023Publication
Not PublishedData no
258676Title
Flumioxazin TechnicalStudy date
August 2023Publication
Not PublishedData no
258672Title
Executive SummaryStudy date
August 2023Publication
Not Published
IMTRADE SENTINEL 800 SL INSECTICIDE
Application Date
12-Sep-2023
Application Number
141301
Application Date
12-Sep-2023Application Number
141301Application Details
Product name
IMTRADE SENTINEL 800 SL INSECTICIDEProduct no
94032Applicant name
IMTRADE AUSTRALIA PTY LTDApplication purpose and description of use
Re-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
258678Title
CoA - Omethoate TechStudy date
22/10/2022Publication
-Data no
258679Title
ChemAg Sentinel 800 Insecticide Spray - Varied label following the reconsideration of Omethoate APVMA Approval No. 59872/RV1216Study date
2023Publication
-Data no
258680Title
EM advice regarding re-registration of Product & Registration expiring after 30/6/23 adviceStudy date
20/07/2023Publication
-Data no
258677Title
Notice of Registration dated 8/12/2005 & Formulation detailsStudy date
08/12/2005Publication
-Reference Details
59872 - CHEMAG SENTINEL 800 INSECTICIDE SPRAY
AMOXI-SOL
Application Date
12-Sep-2023
Application Number
141303
Application Date
12-Sep-2023Application Number
141303Application Details
Product name
AMOXI-SOLProduct no
56236Applicant name
DOX-AL AUSTRALIA PTY LTDApplication purpose and description of use
Variation of product registration and label approval to vary product particularsActive constituents
Active constituent name
57737 - AMOXYCILLIN TRIHYDRATEActive constituent name
83640 - AMOXYCILLIN TRIHYDRATEActive constituent name
88884 - Amoxycillin TrihydrateReference Details
36443 - CCD AMOXYCILLIN TRIHYDRATE FOR POULTRY
CEFALONIUM DIHYDRATE
Application Date
12-Sep-2023
Application Number
141306
Application Date
12-Sep-2023Application Number
141306Application Details
Product name
CEFALONIUM DIHYDRATEActive name
CEFALONIUM DIHYDRATEApplicant name
ALLEVA ANIMAL HEALTH LTDApplication purpose and description of use
Approval of cefalonium dihydrate for use in veterinary chemical products.Description of data provided
Data no
258681Title
Certificates of analysisStudy date
2023Publication
Appendix 1_Cefalonium_CoAs.pdf;2282110
Fenpropidin
Application Date
11-Sep-2023
Application Number
141048
Application Date
11-Sep-2023Application Number
141048Application Details
Product name
FenpropidinActive name
FenpropidinApplicant name
SYNGENTA AUSTRALIA PTY LTDApplication purpose and description of use
Approval of a new source of fenpropidin for use in agricultural chemical products.Description of data provided
Data no
257445Title
Fenpropidin - Validation of Analytical Method SA-101/1Study date
April 2015Publication
-Data no
257446Title
Fenpropidin - Validation of Analytical Method SB-99/1Study date
July 2015Publication
-Data no
257442Title
Fenpropidin - Analysis of Five Representative Batches Produced at BASF, GermanyStudy date
September 2021Publication
-Data no
257443Title
Manufacturing Process Description FENPROPIDIN (CGA114900)Study date
August 2023Publication
-Data no
257444Title
Declaration of CompositionStudy date
August 2023Publication
-Data no
257441Title
230810 CGA114900 Part 2Study date
August 2023Publication
-
IMTRADE ARCHITECT RMR INSECTICIDE
Application Date
11-Sep-2023
Application Number
141132
Application Date
11-Sep-2023Application Number
141132Application Details
Product name
IMTRADE ARCHITECT RMR INSECTICIDEProduct no
93979Applicant name
IMTRADE AUSTRALIA PTY LTDApplication purpose and description of use
Registration of a 50g/L EMAMECTIN present as Emamectin Benzoate + 150g/L PIPERONYL BUTOXIDE emulsifiable concentrate product for the control of various Lepidopteran Pests Cotton, Canola, Pulses, Brassica Vegetables, Capsicum, Lettuce, Grapes, Sweetcorn and Tomatoes as specified in the Directions for Use table.Active constituents
Active constituent name
69065 - EMAMECTIN BENZOATEActive constituent name
65954 - PIPERONYL BUTOXIDEDescription of data provided
Data no
257720Title
CoA Emamectin TechStudy date
22/03/2022Publication
-Data no
257721Title
CoA Piperonyl ButoxideStudy date
10/12/2022Publication
-Data no
257718Title
Emamectin 50 + Piperonyl Butoxide 150 EC Method Validation ??? July 2022Study date
01/07/2022Publication
-Data no
257717Title
Emamectin 50 + Piperonyl Butoxide 150 EC Insecticide 1 Batch Analysis - July 2022Study date
01/07/2022Publication
-Data no
257715Title
Method of Manufacture - Emamectin 50 + Piperonyl Butoxide 150 EC InsecticideStudy date
04/07/2022Publication
-Data no
257719Title
Safety Data Sheets for other ConstituentsStudy date
07/12/2022Publication
-Data no
257722Title
Argument to satisfy Section 14(3) AgVet Chemicals Code Act 1994 in countering the commercial in confidence aspects of the reference product???s non-protected dataStudy date
08/12/2022Publication
-Data no
257716Title
Formulation and Stability Report - Emamectin 50 + Piperonyl Butoxide 150 EC InsecticideStudy date
04/07/2022Publication
-Data no
257731Title
Investigation into the Bio-efficacy of IMTRADE ARCHITECT?? RMR?? INSECTICIDE compared to IMTRADE ACTIVIST?? 225 VeripHy?? SL INSECTICIDE for the control of Cabbage White Butterfly on Brussel Sprouts cv. Divino (Brassica oleracea var. gemmifera). ??? One Trial, Longhorne Creek, South Australia.Study date
10/11/2022Publication
-Data no
257732Title
Investigation into Bio-efficacy of IMTRADE ARCHITECT?? RMR?? INSECTICIDE compared to IMTRADE ACTIVIST?? 225 VeripHy?? SL INSECTICIDE for the control of Light Brown Apple Moth on Grapevines cv. Cabernet Sauvignon (Vitis vinifera). ??? One Trial, Longhorne Creek, South Australia.Study date
03/03/2023Publication
-Data no
257733Title
Investigation into the Bio-equivalency of IMTRADE ARCHITECT?? RMR?? INSECTICIDE compared to AFFIRM INSECTICIDE for the control of Diamondback Moth in Canola cv. Bonito. ??? One Trial, Newdegate, Western Australia.Study date
02/02/2022Publication
-Data no
257734Title
Investigation into the Bio-equivalency of IMTRADE ARCHITECT?? RMR?? INSECTICIDE compared to AFFIRM INSECTICIDE for the control of Heliothis (Helicoverpa punctigera) in Lupins cv. Barlock. ??? One Trial, Newdegate, Western Australia.Study date
02/02/2023Publication
-Data no
257735Title
Investigation into the Bio-efficacy of IMTRADE ARCHITECT?? RMR?? INSECTICIDE to that of AFFIRM INSECTICIDE for the control of Lepidopteran Pests of Cotton cv. Sicot 711RRF. ??? One Trial, Forrest Hill, Queensland.Study date
20/02/2023Publication
-Data no
257736Title
Investigation into the Bio-efficacy of IMTRADE ARCHITECT?? RMR?? INSECTICIDE for the control of Lepidopteran Pests of Chinese Cabbage cv. Kilakin. ??? One Trial, Peak Crossing, Queensland.Study date
18/07/2023Publication
-Data no
257737Title
Investigation into the Bio-efficacy of IMTRADE ARCHITECT?? RMR??INSECTICIDE for the control of Cotton Bollworm on Iceberg Lettuce cv. Roundhouse ??? One Trial, Peak Crossing, Queensland.Study date
27/06/2023Publication
-Data no
257740Title
Commentary to support Efficacy and HCS data submittedStudy date
24/07/2023Publication
-Data no
257738Title
Investigation into the Host Crop Safety of IMTRADE ARCHITECT?? RMR?? INSECTICIDE for the control of Lepidopteran Pests in Tomato cv. Aroma (Solanum lucopersicum) ??? One Trial, Murray Bridge, South Australia.Study date
02/05/2023Publication
-Data no
257739Title
Investigation into the Host Crop Safety of IMTRADE ARCHITECT?? RMR?? INSECTICIDE when applied as a foliar spray for the control of Lepidopteran Pests of Sweetcorn cv. ???Max??? (Zea mays) ??? One Trial, Kuitpo, South Australia.Study date
03/05/2023Publication
-Data no
257723Title
OHS Report Imtrade ARCHITECT?? RMR?? InsecticideStudy date
21/07/2023Publication
-Data no
257730Title
Argument Against Tendering Residues Trials Data in Support of Registration Application for Imtrade Architect RMR InsecticideStudy date
24/07/2023Publication
-Data no
257725Title
Acute Dermal Toxicity Study of Imtrade ARCHITECT?? RMR?? Insecticide (Emamectin 50g/L present as emamectin benzoate & Piperonyl Butoxide 150g/L) in Wistar RatsStudy date
30/06/2023Publication
-Data no
257728Title
Acute Eye Irritation/Serious Eye Damage Study of Imtrade ARCHITECT?? RMR?? Insecticide (Emamectin 50g/L present as emamectin benzoate & Piperonyl Butoxide 150g/L) in New Zealand White RabbitsStudy date
27/07/2023Publication
-Data no
257726Title
Acute Inhalation Toxicity Study of Imtrade ARCHITECT?? RMR?? Insecticide (Emamectin 50g/L present as emamectin benzoate & Piperonyl Butoxide 150g/L) in Wistar Rats along with Dose Concentration Verification ReportStudy date
03/08/2023Publication
-Data no
257724Title
Acute Oral Toxicity Study of Imtrade ARCHITECT?? RMR?? Insecticide (Emamectin 50g/L present as emamectin benzoate & Piperonyl Butoxide 150g/L) in Wistar RatsStudy date
30/06/2023Publication
-Data no
257727Title
Acute Dermal Irritation/Corrosion Study of Imtrade ARCHITECT?? RMR?? Insecticide (Emamectin 50g/L present as emamectin benzoate & Piperonyl Butoxide 150g/L) in New Zealand White RabbitsStudy date
20/06/2023Publication
-Data no
257729Title
Skin Sensitisation Potential of Imtrade ARCHITECT?? RMR?? Insecticide (Emamectin 50g/L present as emamectin benzoate & Piperonyl Butoxide 150g/L) in Guinea PigsStudy date
21/07/2023Publication
-Reference Details
51321 - AFFIRM INSECTICIDE
50919 - PROCLAIM INSECTICIDE
92346 - IMTRADE ACTIVIST 225 VERIPHY SL INSECTICIDE
85276 - IMTRADE ELLIAS 300 EC INSECTICIDE
DRONTAL ALLWORMER FOR LARGE DOGS
Application Date
11-Sep-2023
Application Number
141178
Application Date
11-Sep-2023Application Number
141178Application Details
Product name
DRONTAL ALLWORMER FOR LARGE DOGSProduct no
35824Applicant name
VETOQUINOL AUSTRALIA PTY LTDApplication purpose and description of use
Variation of product label approval to Vet labelling guidelines and update sites of manufacture.Active constituents
Active constituent name
81958 - PRAZIQUANTEL
DRONTAL ALLWORMER FOR MEDIUM DOGS
Application Date
11-Sep-2023
Application Number
141179
Application Date
11-Sep-2023Application Number
141179Application Details
Product name
DRONTAL ALLWORMER FOR MEDIUM DOGSProduct no
35822Applicant name
VETOQUINOL AUSTRALIA PTY LTDApplication purpose and description of use
Variation of product label approval to Vet labelling guidelines and update sites of manufacture.Active constituents
Active constituent name
55169 - FEBANTELActive constituent name
81958 - PRAZIQUANTEL
Sell Plus 800 WG Fungicide and Miticide
Application Date
11-Sep-2023
Application Number
141187
Application Date
11-Sep-2023Application Number
141187Application Details
Product name
Sell Plus 800 WG Fungicide and MiticideProduct no
94000Applicant name
Agrow Allied Ventures Pvt. Ltd.Application purpose and description of use
Registration of a 800 g/kg sulfur WG fungicide and miticide product for control of certain fungal diseases and mites in various agricultural crops.Description of data provided
Data no
258231Title
Certificate of analysisStudy date
15/07/2023Publication
-Data no
258232Title
Information on IngredientsStudy date
June 2023Publication
-Data no
258236Title
Instrument conditionsStudy date
29/06/2023Publication
-Data no
258234Title
Certificate of analysisStudy date
12/10/2020Publication
-Data no
258233Title
Formulation processStudy date
19/11/2020Publication
-Data no
258237Title
Material Safety Data SheetStudy date
29/06/2023Publication
-Data no
258238Title
Part 2 SummaryStudy date
August 2023Publication
-Data no
258235Title
Accelerated storage stability report.Study date
18/07/2023Publication
-Reference Details
62282 - UNISHIELD FUNGICIDE, MITICIDE AND INSECTICIDE
Pestmaster Organic Weed killer Concentrate
Application Date
11-Sep-2023
Application Number
141271
Application Date
11-Sep-2023Application Number
141271Application Details
Product name
Pestmaster Organic Weed killer ConcentrateProduct no
90700Applicant name
TRIOX PTY. LTD.Application purpose and description of use
Variation of product registration to include the formulation details and an additional manufacturing site.Description of data provided
Data no
258535Title
Consent for Pestmaster Organic Weed Killer ConcentrateStudy date
25 August 2023Publication
-Data no
258536Title
Triox - Appointment of Authorised AgentStudy date
28 August 2023Publication
-
Pestmaster Organic Weed Killer Ready to Use
Application Date
11-Sep-2023
Application Number
141282
Application Date
11-Sep-2023Application Number
141282Application Details
Product name
Pestmaster Organic Weed Killer Ready to UseProduct no
90698Applicant name
TRIOX PTY. LTD.Application purpose and description of use
Variation of product registration to add formulation details and an additional manufacturing site.Description of data provided
Data no
258538Title
Consent for Pestmaster Organic Weed Killer Ready to UseStudy date
25 August 2023Publication
-Data no
258539Title
Triox - Appointment of Authorised AgentStudy date
28 August 2023Publication
-
Folpet
Application Date
08-Sep-2023
Application Number
140880
Application Date
08-Sep-2023Application Number
140880Application Details
Product name
FolpetProduct no
93908Applicant name
ADAMA AUSTRALIA PTY LIMITEDApplication purpose and description of use
Registration of a Folpet 800WG fungicide product for proposed use in Grapes, in conjunction with approval of Folpet active constituent (application number to be approved).Description of data provided
Data no
256579Title
Validation technical 2009 ???????? Report no. R- 26067B _000067471-0.2Study date
29 Oct 2009Publication
-Data no
256573Title
Technical folpet- Determination of impurity profiles of five technical batches, Report no. R-26067A-000067393-0.2Study date
27-10-2009Publication
-Data no
256578Title
Impurity profile technical 5Batches-2015 ???????? Report no. 0R-35962_000082618-0.2Study date
6 Oct 2015Publication
-Data no
256574Title
Folpet technical Manufacturing processStudy date
Nov 2021Publication
-Data no
256575Title
Folpet technical SpecificationStudy date
12 Jul 2023Publication
-Data no
256571Title
Document MCA section 1 -Identity folpet technicalStudy date
Jan 2016Publication
-Data no
256572Title
Document MCA Section 2-Physchem properties all folpet technicalStudy date
Jan 2016Publication
-Data no
256586Title
SDS raw materials folpet technical manufactureStudy date
Jul 2023Publication
-Data no
256624Title
Part 2 - ChemistryStudy date
2023Publication
-Data no
257941Title
Document MCA Section 4_Final analytical methodsStudy date
Jan 2016Publication
-Data no
258026Title
MCA Section 3_Final folpet technical additional informationStudy date
JAN 2016Publication
-Data no
256576Title
Determination of folpet technical stability. Report no. 000008790-0.2Study date
9 Jul 1992Publication
-Data no
256577Title
Folpet technical stability 8-12 month. Report no. 00R6842_000041342-0.2Study date
Jul 1993Publication
-Data no
256583Title
Validation study and impurities in Folpet 800WG. Report no. 0R-25261_000065364-0.2Study date
29 Jul 2009Publication
-Data no
257943Title
Folpan ? Oncogenicity study in the mouse Vol 1Study date
24-10-1985Publication
-Data no
257816Title
14C Folpet- comparison of the in-vitro dermal absorption using human and rat skin with the in-vivo dermal absorption in the male ratStudy date
16 June 2006Publication
-Data no
257817Title
Dominant Lethal assay Phaltan technical Rat-Chevron Folpet technical Human Safety data, Project no. IIA 5.4.3-02-R6121, Study no..EPG Reg no 239-1763Study date
15-02-1980Publication
-Data no
257819Title
Physiochemical properties of FOLPET active substanceStudy date
July 2023Publication
-Data no
257827Title
The acute dermal toxicity of Chevron Folpet technical (SX-1346) in adult male and female RabbitsStudy date
11-10-1982Publication
-Data no
257828Title
Folpet technical: Acute dermal toxicity (Limit test) in the RatStudy date
03-01-1992Publication
-Data no
257829Title
Folpet?A study of dermal penetration of 14C -Folpet in the rat- DAR
Study date
17-10-1990Publication
-Data no
257830Title
Comparison of the penetration of 14 pesticides through the skin of young and adult ratsStudy date
1987Publication
-Data no
257831Title
Acute dermal toxicity Rat -ProductStudy date
18-09-1998Publication
-Data no
257832Title
Acute dermal toxicity Rat -ProductStudy date
10-02-2009Publication
-Data no
257833Title
Acute dermal toxicity Rat -ProductStudy date
16-02-1996Publication
-Data no
257834Title
Phaltan- Eye irritation test on Rabbits phaltan technical (PN 2623)Study date
08-09-1982Publication
-Data no
257835Title
Primary eye irritation of Folpan technical on New Zealand Albino RabbitsStudy date
6-4-1979Publication
-Data no
257836Title
Folpet technical: Acute eye irritation test in the RabbitStudy date
09-01-1992Publication
-Data no
257837Title
Folpet Technical (micronised) ? Acuter eye irritation test in the rabbitStudy date
28-10-1993Publication
-Data no
257840Title
Acute Inhalation StudyStudy date
4-11-1998Publication
-Data no
257841Title
Folpet technical (micronized): Acute inhalation toxicity study in the ratStudy date
15-10-1993Publication
-Data no
257842Title
Folpet Technical (micronized): Acute inhalation toxicity study in the RatStudy date
15-10-1993Publication
-Data no
257843Title
Folpet ? 4 hour LC50 Toxicity study of Folpan technicalStudy date
11-06-1979Publication
-Data no
257846Title
Acute inhalation toxicity Rat- technical FolpetStudy date
14-04-1988Publication
-Data no
257847Title
Acute oral toxicity Rat -technical FolpetStudy date
16-05-1983Publication
-Data no
257848Title
Folpet Technical: Acute Oral toxicity (Limit test) in the RatStudy date
03-01-1992Publication
-Data no
257849Title
Phaltan: A four week pilot oral toxicity study in Dogs with Folpet technical final reportStudy date
17-03-1983Publication
-Data no
256625Title
Part 3 Tox and Part 6 WHS combined- Folpet and Folpet 800WGStudy date
2023Publication
-Data no
257852Title
Folpet Technical (micronized): Acute dermal irritation test in the RabbitStudy date
13-10-1993Publication
-Data no
257853Title
Folpet?Intestinal irritation in CD-1 mice after a 24 hour exposure to folpet - DAR
Study date
26-02-2004Publication
-Data no
257857Title
Acute toxicological study of Folpet after intraperitoneal application to the RatStudy date
June 1983Publication
-Data no
257858Title
Folpet Technical (micronized): Delayed contact hypersensitivity study in the guinea-pigStudy date
25-12-1995Publication
-Data no
257869Title
A 21 ? day feeding study of technical Phaltan in RatsStudy date
23-03-1979Publication
-Data no
257874Title
Phaltan- Volume I of XII ? Two generation (two litter) reproduction study in rats with Chevron folpet technicalStudy date
19-09-1985Publication
-Data no
257875Title
Phaltan- Volume XII of XII ? Two generation (two litter) reproduction study in rats with Chevron folpet technicalStudy date
19-09-1985Publication
-Data no
257876Title
Histopathologic evaluation of rats in a reproduction study with Chevron Folpet Technical ( SX-1388)Study date
19-09-1985Publication
-Data no
257878Title
Folpan ? Tetralogy study in the ratStudy date
20-11-1985Publication
-Data no
257879Title
Phaltan- Teratology study in rats with folpet technical final reportStudy date
23-08-1983Publication
-Data no
257883Title
Phaltan -Teratology study in rabbits with Folpet technical using a ?pulse dosing? regimen chevron protocol S-2512
Study date
08-08-1985Publication
-Data no
257884Title
Phaltan -Teratology study in rabbits with Folpet technical using a ?pulse dosing? regimen chevron protocol 11.158 - DAR