For many applications, the Australian Pesticides and Veterinary Medicines Authority (APVMA) is required to publish a summary of the application once the applicant has been notified that the application has been accepted for assessment. The summary will be removed once the application is finalised.
The types of applications requiring an application summary include those for new active constituents, products and labels and applications involving variation to products and labels, where the variation involves a change in the use, supply or disposal of the product.
The summaries include details of the applications as specified in Divisions 2.1 and 2.2 of the regulations.
Please remember to follow the guidance for preparing information lists when preparing your application to avoid sensitive information being published.
For more information, please see the questions and answers.
Use the filter and links below to find and view application summaries.
Date
Application Date
Application No
Application Number
148690
Product/Active constituent Name
Application Product Name
DORACIDE POUR-ON ENDECTOCIDE
Application Date
Application Number
148690
Application Product Name
DORACIDE POUR-ON ENDECTOCIDE
Application details
Product name:
DORACIDE POUR-ON ENDECTOCIDE
Product number:
96262
Applicant Name:
BIMEDA (AUSTRALIA) PTY. LIMITED
Application purpose and description of use:
Registration of a 5 mg/mL doramectin pour-on product for the treatment and control of doramectin sensitive internal and external parasites of cattle.
Reference details:
49665 - DECTOMAX POUR-ON ENDECTOCIDE
Active constituents:
Active constituent name
95759 - Doramectin
Description of data provided:
Data no
287279
Title
Product specifications
Study date
2025
Auth party contact address
Level 31, Suite 31.01 International Towers 264 George Street SYDNEY Australia
Data no
287280
Title
GMP
Study date
2022
Auth party contact address
Level 31, Suite 31.01 International Towers 264 George Street SYDNEY Australia
Data no
287281
Title
GMP
Study date
2023
Auth party contact address
Level 31, Suite 31.01 International Towers 264 George Street SYDNEY Australia
Date
Application Date
Application No
Application Number
149001
Product/Active constituent Name
Application Product Name
3-decen-2-one
Application Date
Application Number
149001
Application Product Name
3-decen-2-one
Application details
Product name:
3-decen-2-one
Product number:
96337
Applicant Name:
AGNOVA TECHNOLOGIES PTY LTD
Application purpose and description of use:
Registration of a 3-decen-2-one at 828 g/L hot fogging concentrate product for use as a potato sprout inhibitor, in conjunction with approval of 3-decen-2-one.
Description of data provided:
Data no
288687
Title
AMVAC-1018 Vapour Pressure. Report No. MIB0002. AMVAC ref. 965-PCH-001
Study date
2009
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288693
Title
Production Process for AMVAC1018 Potato Sprout Inhibitor Technical Grade. AMVAC ref. 965-PCH-008
Study date
2009
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288699
Title
Certificate of Analysis
Study date
2025
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288707
Title
AMV-1018 Dermal Sensitisation Study in Guinea Pigs (Buehler Method) ??? position paper. AMVAC ref. 965-ACT-006b
Study date
2014
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288696
Title
3-DECEN-2-ONE - Innovative Organochem QC analyses (2020). Report No. RAD-2021-078. AMVAC ref. 965-PCH-053
Study date
2021
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288690
Title
Product Chemistry. Measurement of Storage Stability and Corrosion Characteristics of AMV1018 TGAI. Report No. ECS238-5. AMVAC ref. 965-PCH-020
Study date
2011
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288708
Title
3-Decen-2-one PC Code 068403 Final Work Plan Case Number 6317, United States Environmental Protection Agencyy
Study date
2023
Auth party contact address
-
Data no
288685
Title
3-decen-2-one physical/chemical tests final report. Report No. J18495. AMVAC ref. 965-PCH-019
Study date
2011
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288691
Title
Physical and chemical properties and shelf-life storage stability tests for SmartBlock (3-decen-2-one). Report No. 22734. AMVAC ref. 965-PCH-030
Study date
2014
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288705
Title
AMV-1018 Primary Eye Irritation Study in Rabbit. AMVAC ref. 965-ACT-004
Study date
2009
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288688
Title
AMV-1018 Dissociation constant. Report No. BDG0215. AMVAC ref. 965-PCH-027
Study date
2014
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288702
Title
AMV-1018 Acute Inhalation Toxicity Study in Rat. AMVAC ref. 965-ACT-003a
Study date
2009
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288694
Title
Materials Used for Production of AMV1018 Potato Sprout Inhibitor Technical Grade. AMVAC ref. 965-PCH-007
Study date
2009
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288706
Title
AMV-1018 Dermal Sensitisation Study in Guinea Pigs (Buehler Method). AMVAC ref. 965-ACT-006a
Study date
2009
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288689
Title
3-decen-2-one: Determination of the explosive and oxidizing properties. Report No. AMVEUAII/EN-01. AMVAC ref. 965-PCH-025
Study date
2011
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288703
Title
AMV-1018 Acute Inhalation Toxicity Study in Rat (position paper). AMVAC ref. 965-ACT-003b
Study date
2012
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288697
Title
3-Decen-2-one Method Validation. Report no. BDG0139. AMVAC ref. 965-PCH-021
Study date
2012
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288686
Title
Physical and Chemical Characteristic: Color, Physical State, Odor, Stability to Normal and Elevated Temperature, pH, UV/Visible Absorption, Boiling Point, Density/Relative Density, Partition Coefficient, and Water Solubility, Report No. 27395. AMVAC ref. 965-PCH-003
Study date
2009
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288700
Title
AMV-1018 Acute Oral Toxicity Up and Down Procedure in Rats. AMVAC ref. 965-ACT-001
Study date
2009
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288701
Title
AMV-1018 Acute Dermal Toxicity in Rats ??? Limit Test. AMVAC ref. 965-ACT-002
Study date
2009
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288695
Title
3-DECEN-2-ONE - Innovative Organochem QC analyses. Report No. RAD-2019-025. AMVAC ref. 965-PCH-049
Study date
2019
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288692
Title
SmartBlock: Two-year storage stability under warehouse conditions. AMVAC ref. 965-PCH-045
Study date
2017
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288704
Title
AMV-1018 Primary Skin Irritation Study in Rabbits. AMVAC ref. 965-ACT-005
Study date
2009
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288698
Title
Signed Declaration of Composition
Study date
2025
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Date
Application Date
Application No
Application Number
149002
Product/Active constituent Name
Application Product Name
SmartBlock Potato Sprout Inhibitor
Application Date
Application Number
149002
Application Product Name
SmartBlock Potato Sprout Inhibitor
Application details
Product name:
SmartBlock Potato Sprout Inhibitor
Product number:
96338
Applicant Name:
AGNOVA TECHNOLOGIES PTY LTD
Application purpose and description of use:
Registration of a 3-decen-2-one at 828 g/L hot fogging concentrate product for use as a potato sprout inhibitor, in conjunction with approval of 3-decen-2-one.
Description of data provided:
Data no
288633
Title
Mammalian Micronucleus Test of Murine Peripheral Blood Cells with AMV-1018. AMVAC ref. 965-GEN-001
Study date
2009
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288664
Title
Acute toxicity of 3-decen-2-one to Daphnia magna in a semi static test 48-hour immobilisation test.
Study date
2011
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288679
Title
Trials for the assessment of taint in potatoes following treatment with SmartBlock????
Study date
2016
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288627
Title
3-Decen-2-one - Determination of Radioactivity Concentrations in Bone Marrow. AMVAC ref. 965-ADM-003
Study date
2018
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288670
Title
Part 8 - Efficacy and Safety
Study date
2025
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288624
Title
PAA-133279: APVMA written advice
Study date
2021
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288673
Title
Evaluation of the Novel Potato Sprout Inhibitor AMV-1018
Study date
2012
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288644
Title
SmartBlock Part 2 - Residues
Study date
2025
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288656
Title
3-Decen-2-one ???????? waiver request for the conduct of a hydrolysis study.
Study date
2014
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288650
Title
Residue of AMV 1018 in raw, baked, and steamed 'Ranger Russet' potatoes.
Study date
2012
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288636
Title
Scientific Opinion on Flavouring Group Evaluation 204. Revision 1 (FGE.204Rev1): consideration of genotoxicity data on representatives for 17 monounsaturated, aliphatic, ??,??-unsaturated ketones and precursors from chemical subgroup 1.2.1 of FGE.19.
Study date
2019
Auth party contact address
-
Data no
288630
Title
AMV-1018: Study for Effects on Embryo-Fetal Development in the CD Rat by Oral Gavage Administration. AMVAC ref. 965-DAR-002
Study date
2012
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288667
Title
3-Decen-2-one (AMV-1018): algal growth inhibition test.
Study date
2019
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288676
Title
The effect of SmartBlock (AMV 1018) on sprouting behaviour and quality of ware potatoes (processing) in storage (2014-2015).
Study date
2016
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288653
Title
Peer Review of the Pesticide Risk Assessment of the Active Substance (3E)-dec-3-en-2-one.
Study date
2022
Auth party contact address
-
Data no
288647
Title
3-Decen-2-one: validation of analytical methodology for the determination of residues of 3-decen-2-one and its metabolites 2-decanone and 2-decanol in potato peel and pulp.
Study date
2015
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288639
Title
AMV-1018 - literature search update for approval of active substance under Reg. 1107/2009. AMVAC ref. 965-REV-017
Study date
2017
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288662
Title
3-Decen-2-one EPI SuiteTM results.
Study date
2014
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288631
Title
Reverse Mutation Assay using Bacteria (Salmonella typhimurium) with AMV-1018. AMVAC ref. 965-GEN-002
Study date
2009
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288668
Title
Toxicity of 3-decen-2-one to activated sludge in a respiration inhibition test.
Study date
2011
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288622
Title
Biopesticides Registration Action Document 3-decen-2-one, US Environmental Protection Agency
Study date
2013
Auth party contact address
-
Data no
288642
Title
Memorandum: Joint Science Review with Health Canada Pest Management Regulatory Agency (PMRA) in Support of the Registration of AMV-1018 Technical Containing 98.0% of 3-Decen-2-One as its Active Ingredient
Study date
2013
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288648
Title
Independent laboratory validation of analytical methods for the determination of 3-decen-2-one, 2-decanone and 2-decanol in potato (peel and pulp).
Study date
2019
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288682
Title
Efficacy of sprout suppressants used alone, or in combination, to control sprouting of stored potato.
Study date
2020
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288659
Title
ECHA Guidance on information requirements and chemical safety assessment. Chapter R.16: Environmental exposure assessment. Version 3.0.
Study date
2016
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288619
Title
SmartBlock Part 2 - Chemistry
Study date
2025
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288665
Title
Toxicity of 3-Decen-2-one to the aquatic plant Lemna gibba in a semi-static growth inhibition test in closed vessel design.
Study date
2012
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288628
Title
AMV-1018: Dose Range Finding Study by Inhalation Administration to Rats. AMVAC ref. 965-SCH-001
Study date
2014
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288671
Title
Preliminary Assessment of Potato Sprout Inhibition by AMV-1018
Study date
2009
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288674
Title
Efficacy of Smartblock applied alone or in program during storage as sprout suppressant for potatoes stored at different temperatures.
Study date
2015
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288625
Title
SmartBlock Part 3 - Toxicology
Study date
2025
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288645
Title
3-Decen-2-one: potato fogging ???????? laboratory mass balance investigation.
Study date
2017
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288651
Title
SmartBlock Part 6 - Occupational Health and Safety
Study date
2025
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288637
Title
Human health assessment for 2-decanol and 2-decanone; metabolites of 3-decen-2-one (AMV-1018). AMVAC ref. 965-REV-012
Study date
2014
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288683
Title
Efficacy of sprout suppressants used alone, or in combination, to control sprouting of stored potato.
Study date
2021
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288660
Title
Technical Guidance document on Risk Assessment in support of Commission Directive 93/67/EEC on Risk Assessment for new notified substances, Commission Directive 1488/94/EEC on Risk Assessment for existing substances and Commission Directive 98/8/EEC of the European Parliament and of the Council concerning the placing of biocidal products on the market, Part II.
Study date
2003
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288620
Title
3-Decen-2-one Batch Analysis. Report No. BDG0140. AMVAC ref. 965-PCH-022
Study date
2012
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288677
Title
Evaluation of PAG10001 in ware potatoes on sprout suppression with variation in application frequency and -method (De Eest, 2014-2015).
Study date
2015
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288666
Title
Toxicity of 3-decen-2-one to Pseudokirchneriella subcapitata in an algal growth inhibition test.
Study date
2012
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288626
Title
3-decen-2-one: Pharmacokinetics and Metabolite Profiling in Rats. AMVAC ref. 965-ADM-002
Study date
2017
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288654
Title
Justification and Details of RISKOFDERM Model for Calculation of Operator Exposure to 3-Decen-2-one in SmartBlock????
Study date
2021
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288646
Title
Metabolite radioprofiling and identification in stored potatoes following a single application of [14C] 3-decen-2-one.
Study date
2020
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288634
Title
AMV-1018: In Vivo Liver Unscheduled DNA Synthesis (UDS) Assay. AMVAC ref. 965-GEN-004
Study date
2011
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288640
Title
Literature search for data on endocrine disrupting potential for nontarget organisms of (3E)-3-decen-2-one (CAS no. 10519-33-2) and its metabolites, 2-decanone (CAS no. 693-54-9) and 2-decanol (CAS no. 1120-06-5) for the period 2016-2020. AMVAC ref. 965-REV-025
Study date
2021
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288657
Title
United States Patent Number 4,871,881.
Study date
1989
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288663
Title
Acute toxicity of 3-decen-2-one to rainbow trout (Oncorhynchus mykiss).
Study date
2011
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288680
Title
SMARTBLOCK sprout inhibito: An evaluation of sprout suppression in potatoes.
Study date
2017
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288669
Title
3-Decen-2-one: determination of effects in sediment on emergence of the midge, Chironomus riparius.
Study date
2019
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288623
Title
Certificate of name change for Innovative Organochem Pvt. Ltd
Study date
2022
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288643
Title
Registration Decision PRD2014-01: 3-decen-2-one, Health Canada Pest Management Regulatory Agency
Study date
2014
Auth party contact address
-
Data no
288658
Title
3-decen-2-one physical/chemical tests final report
Study date
2011
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288681
Title
Sprout control efficacy using SmartBlock???? with and without CIPC.
Study date
2019
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288635
Title
AMV-1018 Wistar Han Rat In Vivo Comet Test. AMVAC ref. 965-GEN-006
Study date
2016
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288629
Title
Justification for selection of 4-phenyl-3-butene-2-one (methyl styryl ketone) as a read-across candidate for 3-decen-2-one (AMV-1018). AMVAC ref. 965-REV-009a
Study date
2014
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288675
Title
Assessment of SmartBlock???? (3-decen-2-one) sprout suppressant applied early or at GAP timing to potatoes held under fresh market storage conditions.
Study date
2015
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288672
Title
Evaluation of the efficacy of various AMVAC 1018 (98%) treatments in combination with other sprout control products and effect of application timing.
Study date
2010
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288652
Title
USA Label for SmartBlock.
Study date
2021
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288661
Title
Ready biodegradability of 3-decen-2-one in a manometric respirometry.
Study date
2011
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288638
Title
AMV-1018- literature search for approval of active substance under Reg. 1107/2009. AMVAC ref. 965-REV-010
Study date
2014
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288684
Title
Evaluation of SmartBlock application schedules on sprouting behaviour and quality of ware potatoes (processing) in storage (de Eest 2020-2021).
Study date
2021
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288632
Title
In vitro Mammalian Cell Gene Mutation Assay (Thymidine Kinase Locus/TK+/-) in Mouse Lymphoma L5178Y Cells with AMV-1018. AMVAC ref. 965-GEN-003b
Study date
2009
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288678
Title
Efficacy of SmartBlock????: 2016 Commercial Trials Report & Summary.
Study date
2016
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288621
Title
Proposed Regulator Decision PRD2013-12 3-decen-2-one, Health Canada pest management Regulatory Agency
Study date
2013
Auth party contact address
-
Data no
288649
Title
Nature of [14C]3-decen-2-one residues in processed commodities ???????? high temperature hydrolysis.
Study date
2019
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288655
Title
SmartBlock Part 7 - Environmental Toxicology
Study date
2025
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
288641
Title
3-Decen-2-one, 2-decanone, 2 decanol literature search and review. AMVAC ref. 965-REV-028
Study date
2021
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Date
Application Date
Application No
Application Number
148962
Product/Active constituent Name
Application Product Name
RACUMIN TP RAT AND MOUSE RODENTICIDE
Application Date
Application Number
148962
Application Product Name
RACUMIN TP RAT AND MOUSE RODENTICIDE
Application details
Product name:
RACUMIN TP RAT AND MOUSE RODENTICIDE
Product number:
86417
Applicant Name:
2022 ENVIRONMENTAL SCIENCE AU PTY LTD
Application purpose and description of use:
Variation of product registration and label approval for inclusion of bittering agent in the formulation.
Active constituents:
Active constituent name
64241 - COUMATETRALYL
Description of data provided:
Data no
289274
Title
Manufacturing process for Australia
Study date
2025
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289280
Title
Determination of Coumatetralyl in formulations
Study date
2002
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
301305
Title
Field trial to determine the efficacy of coumatetralyl (0.0375%) in controlling house mice (Mus musculus domesticus) on a farm in Muensterland, Germany.
Study date
2009
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289283
Title
HPLC Determination of Denatonium Benzoate in Coumatetralyi CP 075 (7.5 g/kg)
Study date
2020
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289291
Title
Efficacy of Racumin Tracking Powder (0.75% Coumatetralyl) containing 200ppm Bitrex in a Choice Trial with Norway Rats (Rattus norvegicus)
Study date
2019
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289277
Title
Coumatetralyl CP 0.75 Product Specification
Study date
2017
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289271
Title
Part 2 Chemistry and Manufacture
Study date
2025
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289272
Title
Certificate of Analysis Technical Material
Study date
2025
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289289
Title
Racumin TP Rat and Mouse Rodenticide SAFETY DATA SHEET
Study date
2024
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289275
Title
Coumatetralyl CP 0.75 Certificate of Composition for Australia
Study date
2017
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
301306
Title
Impact on Palatability of BITREX (denatonium benzoate) in Grain Bait at 2.5ppm, 5.0ppm and 10ppm in Norway Rats (Rattus norvegicus)
Study date
2018
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289286
Title
Accelerated storage stability of Coumatetralyl CP 0.75 (7.5 g/kg) Study A
Study date
2020
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289292
Title
Efficacy of Racumin Tracking Powder (0.75% Coumatetralyl) Containing 200ppm Bitrex in a Choice Trial with House Mice (Mus musculus)
Study date
2019
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289278
Title
Product Specification Coumatetralyl CP 0.75 (7.5 g/kg)
Study date
2025
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289281
Title
Validation of HPLC-method - Determination of Coumatetralyl in formulations
Study date
2002
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289293
Title
Justification of 200 ppm Concentration of Denatonium Benzoate in Racumin Tracking Powder 0.75
Study date
2020
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289287
Title
Accelerated storage stability of Coumatetralyl CP 0.75 (7.5 g/kg) Study B
Study date
2020
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289290
Title
Part 8 Efficacy and Safety
Study date
2025
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289284
Title
Revalidation of Method MV225 HPLC - Determination of Coumatetralyl in Coumatetralyl CP 075 (7.5 g/kg)
Study date
2020
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289276
Title
Certificate of Composition for Australia
Study date
2025
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289285
Title
Re-Validation of Method MV226 HPLC Determination of Denatonium Benzoate in Coumatetralyl CP 075 (7.5 g/kg)
Study date
2020
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289279
Title
Coumatetralyl CP 0.75 Certificate of Analysis
Study date
2024
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
301304
Title
RACUMIN EXPERT FRESHBAIT 0,0027% COUMATETRALYL
Study date
2025
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289273
Title
Coumatetralyl CP 0.75 Manufacturing procedure for Australia
Study date
2017
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289282
Title
HPLC - Determination of Coumatetralyl in Coumatetralyl CP 075 (7.5 g/kg)
Study date
2020
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Data no
289288
Title
Applicability of CIPAC MT 170 (Dry Sieve Test) to the formulation Coumatetralyl CP 0.75 (7.5 g/kg) - before and after storage
Study date
2025
Auth party contact address
Envu suite 2.06, Level 2 737 Burwood Road HAWTHORN EAST Australia
Date
Application Date
Application No
Application Number
148807
Product/Active constituent Name
Application Product Name
GORNA Fungicide
Application Date
Application Number
148807
Application Product Name
GORNA Fungicide
Application details
Product name:
GORNA Fungicide
Product number:
96287
Applicant Name:
Shandong Rainbow International Co Ltd
Application purpose and description of use:
Registration of a 500g/L Fluopyram suspension concentrate formulation (SC) product , GORNA FUNGICIDE for control of various pest species in Banana as described in the Directions for use section of the label.
Active constituents:
Active constituent name
93993 - Fluopyram
Description of data provided:
Data no
288756
Title
Authorised agent letter
Study date
26 May 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288762
Title
Supporting information- Public release summary- Reference market product
Study date
Apr 2015
Auth party contact address
102 Taylor Street, Armidale, NSW, 2350, Australia
Data no
288742
Title
Manufacturing process of Fluopyram 500g/L SC product
Study date
10 May 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288750
Title
Chromatogram Linearity- Fluopyram 500 g/L SC product
Study date
15 Oct 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288753
Title
Chromatogram Stadard Solution- Fluopyram 500 g/L SC product
Study date
15 Oct 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288759
Title
Toxicological end points - Fluopyram technical
Study date
21 May 2019
Auth party contact address
-
Data no
288739
Title
Part 2 - Chemistry and Manufacture - GORNA Fungicide
Study date
11 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288754
Title
Certificate of analysis - Fluopyram reference std
Study date
15 Oct 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288748
Title
Packaging Specifications
Study date
10 May 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288757
Title
SDS combined- Fluopyram 500SC and other ingredients
Study date
6 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288765
Title
Draft Proposed GORNA Fungicide label
Study date
11 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288751
Title
Chromatogram Accuracy- Fluopyram 500 g/L SC product
Study date
15 Oct 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288745
Title
Accelerated storage stability study on Fluopyram 500 g/L SC
Study date
24 Mar 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288760
Title
Six pack Toxicity - combined report
Study date
24 Oct 2019
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288766
Title
Ref Market standard label
Study date
10 June 2025
Auth party contact address
-
Data no
288740
Title
Declaration of composition of Fluopyram technical
Study date
10 May 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288752
Title
Chromatogram Solvent- Fluopyram 500 g/L SC product
Study date
15 Oct 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288746
Title
Low Temperature storage stability - Fluopyram 500g/L SC
Study date
10 May 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288763
Title
Part 8 - Crop Efficacy and Safety
Study date
11 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288743
Title
Certificate of Analysis - Fluopyram 500g/L SC product
Study date
11 Feb 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288749
Title
Analysis of Method validation part 2- Fluopyram 500g/L SC product
Study date
15 Oct 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288758
Title
Part 3- Toxicity dossier
Study date
10 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288764
Title
Field trial report in Banana crop - Qld 2024
Study date
23 May 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288744
Title
GORNA FUNGICIDE - Manufacturing process
Study date
27 May 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288755
Title
Certificate of Analysis Fluopyram technical
Study date
22 Jul 2023
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288761
Title
Combined SDS- Product and ingredients
Study date
6 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288741
Title
Specifications of Fluopyram 500g/L SC Product
Study date
10 May 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
288747
Title
Method Validation - Fluopyram 500g/L SC product
Study date
15 Oct 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Date
Application Date
Application No
Application Number
149014
Product/Active constituent Name
Application Product Name
Indoxacarb
Application Date
Application Number
149014
Application Product Name
Indoxacarb
Application details
Product name:
Indoxacarb
Active name:
Indoxacarb
Applicant Name:
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
Application purpose and description of use:
Approval of Indoxacarb for use in veterinary chemical products.
Description of data provided:
Data no
307505
Title
Validation of the method for the determination of Impurities in Indoxacarb
Study date
10/03/2026
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
307508
Title
Declaration letter for Explanation and Amendment
Study date
12/03/2026
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
307502
Title
Analysis method for solvents of N,N-dimethylformamide (DMF) during the manufacturing process of Indoxacarb
Study date
03/2026
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
307503
Title
Description of formation of impurities in Indoxacarb
Study date
03/2026
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
289452
Title
Process Validation
Study date
06/2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
307506
Title
Validation of the method for the determination of active ingredient in Indoxacarb
Study date
10/03/2026
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
307501
Title
CERTIFICATE OF ANALYSIS
Study date
16/04/2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
289453
Title
DMF
Study date
06/2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
307507
Title
Composition of Indoxacarb
Study date
03/2026
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
289454
Title
Certificates of analysis
Study date
04/2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
307504
Title
Analysis method of impurities in Indoxacarb
Study date
03/2026
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Date
Application Date
Application No
Application Number
149176
Product/Active constituent Name
Application Product Name
Cefeject + KP Injection for Cattle
Application Date
Application Number
149176
Application Product Name
Cefeject + KP Injection for Cattle
Application details
Product name:
Cefeject + KP Injection for Cattle
Product number:
96396
Applicant Name:
ABBEY LABORATORIES PTY LTD
Application purpose and description of use:
Registration of Cefeject + KP Injection for Cattle containing Ceftiofur (as hydrochloride) 50 mg/mL and Ketoprofen 150 mg/mL for the treatment of respiratory infections in cattle associated with signs of inflammation or pyrexia.
For the treatment of bovine respiratory disease (BRD) caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni susceptible to ceftiofur and the reduction of associated clinical signs of inflammation or pyrexia.
Reference details:
83071 - CURACEF DUO Suspension for Injection for Cattle
Active constituents:
Active constituent name
84288 - CEFTIOFUR HYDROCHLORIDE
Active constituent name
55648 - KETOPROFEN
Active constituent name
94214 - Ketoprofen
Description of data provided:
Data no
310814
Title
Abbeylabs to APVMA chem letter V1 - Cefeject + KP Injection for Cattle
Study date
JUL26
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
289182
Title
Cefeject + KP Injection for Cattle
Study date
Jul 25
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Date
Application Date
Application No
Application Number
148314
Product/Active constituent Name
Application Product Name
ECOVACPLE - E.COLI / PARVOVIRUS / ERYSIPELAS / LEPTOSPIROSIS VACCINE FOR PIGS
Application Date
Application Number
148314
Application Product Name
ECOVACPLE - E.COLI / PARVOVIRUS / ERYSIPELAS / LEPTOSPIROSIS VACCINE FOR PIGS
Application details
Product name:
ECOVACPLE - E.COLI / PARVOVIRUS / ERYSIPELAS / LEPTOSPIROSIS VACCINE FOR PIGS
Product number:
46163
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product registration to add manufacturing sites.
Date
Application Date
Application No
Application Number
148315
Product/Active constituent Name
Application Product Name
ECOVACLE-E.COLI/ERYSIPELAS/LEPTOSPIROSIS VACCINE FOR PIGS
Application Date
Application Number
148315
Application Product Name
ECOVACLE-E.COLI/ERYSIPELAS/LEPTOSPIROSIS VACCINE FOR PIGS
Application details
Product name:
ECOVACLE-E.COLI/ERYSIPELAS/LEPTOSPIROSIS VACCINE FOR PIGS
Product number:
46409
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product registration to add manufacturing sites.
Date
Application Date
Application No
Application Number
148317
Product/Active constituent Name
Application Product Name
ECOVAC E COLI VACCINE FOR PIGS
Application Date
Application Number
148317
Application Product Name
ECOVAC E COLI VACCINE FOR PIGS
Application details
Product name:
ECOVAC E COLI VACCINE FOR PIGS
Product number:
35779
Applicant Name:
INTERVET AUSTRALIA PTY LIMITED
Application purpose and description of use:
Variation of product registration to add manufacturing sites.
Description of data provided:
Data no
307485
Title
VAL-2024-0094 validation report
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
307488
Title
F0304 antigen specifications
Study date
2026
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
307483
Title
VAL-2026-0006 validation report
Study date
2026
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
307486
Title
BTS-2024-2024 validation protocol
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
307487
Title
VAL-2025-0097 validation protocol
Study date
2025
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Data no
307484
Title
VAL-2024-0078-01 validation protocol
Study date
2024
Auth party contact address
Level 1 - Building A, 26 Talavera Road Macquarie Park Australia
Date
Application Date
Application No
Application Number
148930
Product/Active constituent Name
Application Product Name
Robenacoxib
Application Date
Application Number
148930
Application Product Name
Robenacoxib
Application details
Product name:
Robenacoxib
Active name:
Robenacoxib
Applicant Name:
INTAS PHARMACEUTICALS LIMITED
Application purpose and description of use:
Approval of new source of active.
Description of data provided:
Data no
287760
Title
DMF-32s41
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287754
Title
DMF-32s23
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287757
Title
DMF-32s26
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287751
Title
DMF-32s11
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287763
Title
DMF-32s44
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287758
Title
DMF-32s31
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287752
Title
DMF-32s21
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287766
Title
DMF-32s6
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287769
Title
DMF-32s73
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287749
Title
DMF-32s13
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287755
Title
DMF-32s24
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
288056
Title
Certificates of analysis
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287750
Title
DMF-32s12
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287764
Title
DMF-32s45
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287753
Title
DMF-32s22
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287767
Title
DMF-32s71
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287761
Title
DMF-32s42
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287756
Title
DMF-32s25
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287768
Title
DMF-32s72
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287762
Title
DMF-32s43
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287759
Title
DMF-32s32
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287765
Title
DMF-32s5
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Date
Application Date
Application No
Application Number
148989
Product/Active constituent Name
Application Product Name
Fresnil Herbicide
Application Date
Application Number
148989
Application Product Name
Fresnil Herbicide
Application details
Product name:
Fresnil Herbicide
Product number:
96336
Applicant Name:
Shandong Rainbow International Co Ltd
Application purpose and description of use:
Registration of a new Fresnil Herbicide 400g/L bromoxynil (present as bromoxynil octanoate) product label for the control of certain broadleaf weeds in cereals, linseed, clover, lucerne, turf, fallow and non-crop situations as specified in the Directions for use table.
Reference details:
80801 - BRONCO 400 HERBICIDE
Active constituents:
Active constituent name
94182 - Bromoxynil Octanoate
Description of data provided:
Data no
289374
Title
Fresnil Herbicide proposed draft label
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289366
Title
Packagaing specification of Bromoxynil as the Octanoate 400EC
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289357
Title
Recipe information of Bromoxynil present as Octanoate 400EC
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289360
Title
Declaration of Composition of Bromoxynil Octanoate Technical
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289377
Title
Bromoxynil 400 wheat trial Victoria.
Study date
20-10-2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289354
Title
Part 2- Chemistry and Manufacture
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289363
Title
CoA of Bromoxynil Octanoate Std.
Study date
18 Dec 2023
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289380
Title
Reference Market standard label
Study date
30 June 2025
Auth party contact address
-
Data no
289372
Title
Chromatogram of Solvet blank
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289355
Title
Specifications of Bromoxynil as the Octanoate 400 EC
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289369
Title
Chromatograms of Accuracy and Precision
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289375
Title
SDSs_Combined product and other ingredients
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289358
Title
Method Validation for Bromoxynil present as Octanoate 400 EC
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289361
Title
COA of Bromoxynil As the Octanoate 400 EC
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289378
Title
Bromoxynil 400 WHT Trial - Replicated Katanning
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289370
Title
Chromatogram of Bromoxynil content
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289376
Title
Bromoxynil 400 - BLW control in oats undersown to lucerne (SA)
Study date
28-04-2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289364
Title
Low Temperature Stability Report of Bromoxynil(As the Octanoate) 400 EC
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289373
Title
Part 8 - Crop efficacy and safety
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289367
Title
Nominated agent letter
Study date
26 May 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289368
Title
Analysis method of Bromoxynil as the Octanoate 400EC
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289359
Title
Storage Stability Study of Bromoxynil As the Octanoate) 400 EC
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289362
Title
SDS - Combined Product and other ingredients
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289379
Title
Market standard reference label
Study date
29 June 2025
Auth party contact address
-
Data no
289391
Title
Letter Justification
Study date
2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289371
Title
Chromatogram of Linearity
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289356
Title
Manufacturing Process of Bromoxynil 400EC
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
289365
Title
CoA of Bromoxynil Octanoate technical
Study date
30 June 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Date
Application Date
Application No
Application Number
148929
Product/Active constituent Name
Application Product Name
ROBENACOXIB 20 MG/ML SOLUTION FOR INJECTION
Application Date
Application Number
148929
Application Product Name
ROBENACOXIB 20 MG/ML SOLUTION FOR INJECTION
Application details
Product name:
ROBENACOXIB 20 MG/ML SOLUTION FOR INJECTION
Product number:
96322
Applicant Name:
INTAS PHARMACEUTICALS LIMITED
Application purpose and description of use:
Registration of a 20 mg/mL robenacoxib injectable product for the treatment of pain and inflammation associated with orthopaedic or soft tissue surgery in dogs and cats.
Reference details:
63112 - ONSIOR INJECTION FOR CATS AND DOGS
Description of data provided:
Data no
304454
Title
Response
Study date
2026
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
304462
Title
Dossier 3
Study date
2026
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
304460
Title
Validation report
Study date
2024
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
304457
Title
Dossier 1
Study date
2026
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
304463
Title
Dossier 4
Study date
2026
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
304458
Title
Batch record
Study date
2024
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
304455
Title
SPC
Study date
2023
Auth party contact address
-
Data no
304461
Title
Product specifications
Study date
2026
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287744
Title
Product specifications
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
304456
Title
DailyMed
Study date
2026
Auth party contact address
-
Data no
304459
Title
Dossier 2
Study date
2026
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Data no
287745
Title
Certificate
Study date
2025
Auth party contact address
Corporate House Near Sola Bridge S.G. Highway, Thaltej Ahmedabad, India
Date
Application Date
Application No
Application Number
148971
Product/Active constituent Name
Application Product Name
SULFOCROP 800 WG Fungicide and Miticide
Application Date
Application Number
148971
Application Product Name
SULFOCROP 800 WG Fungicide and Miticide
Application details
Product name:
SULFOCROP 800 WG Fungicide and Miticide
Product number:
96332
Applicant Name:
GENERAL CROP SCIENCE
Application purpose and description of use:
Registration of a 800 g/kg Sulphur, Water Dispersible Granule(WG) product for the control of certain fungal diseases in grape vines, ornamentals, pome and stone fruit and vegetables and for control of mites in citrus, grape vines, ornamentals and vegetables and white louse scale in citrus as per the Directions for Use table.
Reference details:
66641 - APPARENT SULFUR 800 WG FUNGICIDE/ MITICIDE/ INSECTICIDE
Date
Application Date
Application No
Application Number
148911
Product/Active constituent Name
Application Product Name
Vantacor Insecticide
Application Date
Application Number
148911
Application Product Name
Vantacor Insecticide
Application details
Product name:
Vantacor Insecticide
Product number:
89966
Applicant Name:
FMC AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of Vantacor Insecticide to add certain additional uses on new crops and against new pests, to the product label.
Reference details:
91353 - Altacor X-Force Insecticide
Active constituents:
Active constituent name
68633 - CHLORANTRANILIPROLE
Active constituent name
61539 - CHLORANTRANILIPROLE
Description of data provided:
Data no
290531
Title
Evaluation of E2Y45 for the control of Lephipoterous pests in Pome Fruit
Study date
2004
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290539
Title
Final Report - Evaluate crop safety and efficacy of Rynaxypyr formulations for Lepidopteran larvae control in brassica vegetables
Study date
2020
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290545
Title
Final Report - Evaluate the crop safety of DPX-E2Y45-SC-HS and DPX-E2Y45-890 +/- tank mixtures in fruiting vegetables (Z1)
Study date
2020
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290528
Title
Evaluation of DPX-E2Y45 for the control of Codling Moth in pears
Study date
2004
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290542
Title
Final Report - Evaluate the crop safety of DPX-E2Y45-SC-HS and DPX-E2Y45-890 +/- tank mixtures in fruiting vegetables (C1)
Study date
2020
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290548
Title
Trial Research Report - Evaluate the crop response and efficacy of Rynaxypyr (R) formualtions for Lepidopteran pest control in Mungbean
Study date
2024
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
288810
Title
Part 8 Dossier - Label registration
Study date
2025
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290537
Title
DPX-E2Y45 SC/WG-Lepidoptera insecticide in cabbage
Study date
2025
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290543
Title
Field Research Report - Evaluate crop safety of Rynaxypyr 600 SC & 320 OD +/- tank mixtures in fruiting vegetables (C)
Study date
2020
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
288811
Title
Vantacor Insecticide word label 2025 updated_JUN 2025
Study date
2025
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290526
Title
Final Report. Comaprison of FMC-001 600 SC and FMC-007 700 WG at dilute and concentrate water volumes FMC-002 200 SC, FMC-006 350 WG, FMC-010 400 SC and FMC-011 825 WG with Teppan 50 SL for the control of codling moth (Cydia pomonella) in apples cv. Royal Gala
Study date
2024
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290534
Title
Evaluation of DPX-E2Y45 for the ocntrol of lepidopteran larvae pests in cabbages
Study date
2003
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290540
Title
Final Report - To evaluate the crop safety of various insecticides in lettuce
Study date
2024
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290546
Title
Field Research Report - Evaluate crop safety of Rynaxypyr 600 SC & 320 OD +/- tank mixtures in fruiting vegetables (Z)
Study date
2020
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290535
Title
A report on the evaluation of insecticides for the ocntrol of heliothis and leaf miner in tomatoes
Study date
2003
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290529
Title
Evaluation of DPX-E2Y45 for the control of Codling Moth Cydia pomonella in Apples
Study date
2004
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290541
Title
Final Report - To evaluate the crop safety of various insecticides in cherry tomato
Study date
2024
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290549
Title
Final Report - To evaluate the crop safety of various insecticides in broccoli
Study date
2024
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290532
Title
Evaluation of the crop response and efficacy of Rynaxypyr formulations for the control of Heliothis in Lettuce.
Study date
2024
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
288809
Title
Part 8 Study reports and supporting data
Study date
2025
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290538
Title
Comparison of E2Y45 200 SC with E2Y45 350 WG and Avatar for the control of lepidopteran larvae in cabbages (cv. Neptune)
Study date
2004
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290533
Title
Comparison of E2Y45 35 WG and 200 SC with and without Agral 60, with Avatar 300 DF when applied on a 4 day spray schedule at 7 day intervals for the control of diamondback moth (Plutella xylostella), cabbage white butterfly (Pieris rapae) and cluster caterpillar (Spodoptera litura) in chinese cabbages cv. Ming Emperor
Study date
2003
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290547
Title
Evaluation of crop safety of foliar sprays of Rynaxypyr 600 SC, Rynaxypyr 320 OD, COragen 200 SC and Benevia 100 OD in tank-mixtures with Agral wetting agent, Bravo Weatherstik 720 SC and Amistar 250 SC on field grown cucumbers cv "Gremlin"
Study date
2021
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290536
Title
DPX-E2Y45 SC - Helicoverpa Insecticide in lettuce
Study date
2025
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290530
Title
Comparison of E2Y45 200 SC and E2Y45 350 WG with Gusathion 200 SC for the control of codling moth (Cydia pomonella) in Delicious apples
Study date
2004
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290544
Title
Field Research Report - Evaluate crop safety of Rynaxypyr 600 SC & 320 OD +/- tank mixtures in fruiting vegetables (R)
Study date
2020
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Data no
290527
Title
Evluate the crop response and efficacy of Rynaxypyr formulations for lepidopteran pest control in Australian vine crops.
Study date
2024
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Date
Application Date
Application No
Application Number
149154
Product/Active constituent Name
Application Product Name
LidoBand for Cattle and Sheep
Application Date
Application Number
149154
Application Product Name
LidoBand for Cattle and Sheep
Application details
Product name:
LidoBand for Cattle and Sheep
Product number:
96385
Applicant Name:
Alberta Veterinary Laboratories Ltd
Application purpose and description of use:
Registration of a 80 mg lidocaine elastration band product for use in castration of calves and lambs.
Active constituents:
Active constituent name
96387 - Lidocaine
Description of data provided:
Data no
289111
Title
Effect of band and knife castration of beef calves on welfare indicators of pain at three relevant industry ages: I. Acute pain
Study date
2017
Auth party contact address
-
Data no
288873
Title
Comparison of 4 topical anesthetic agents for effect and corneal toxicity in rabbits
Study date
1999
Auth party contact address
-
Data no
289088
Title
Transdermal Bioavailability in Rats of Lidocaine in the Forms of Ionic Liquids, Salts, and Deep Eutectic
Study date
2017
Auth party contact address
-
Data no
289134
Title
Efficacy of a Lidocaine-Impregnated Elastrator Band for Castration and Tail Docking in Lambs
Study date
2024
Auth party contact address
-
Data no
289105
Title
Dose Response of Topical Anesthetic on Laryngeal Neuromuscular Electrical Transmission
Study date
2005
Auth party contact address
-
Data no
288879
Title
The absence of teratogenic effects of some analgesics used in anaesthesia. Additional evidence from a mouse model
Study date
1992
Auth party contact address
-
Data no
289071
Title
Study Report 10
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288925
Title
App. 13: Validation report
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289011
Title
App. 6: Data summary
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288865
Title
Lignocaine and chlorhexidine toxicity in children resulting from mouth paint ingestion: a bottling problem
Study date
2006
Auth party contact address
-
Data no
289019
Title
Pharmacokinetics, residue kinetics and residue depletion studies for lignocaine and bupivacaine in sheep and cattle
Study date
2017
Auth party contact address
-
Data no
288965
Title
In vitro metabolism of lidocaine in subcellular post-mitochondrial fractions and precision cut slices from cattle liver
Study date
2021
Auth party contact address
-
Data no
289065
Title
Study Report 16 App 8
Study date
2022
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288919
Title
Evaluation of the cytotoxicity of orthodontic separating elastics
Study date
2010
Auth party contact address
-
Data no
288862
Title
What is 'excipient'?
Study date
2024
Auth party contact address
-
Data no
289028
Title
Are VETERINARY MEDICINES Causing Environmental Risks?
Study date
2003
Auth party contact address
-
Data no
288885
Title
Effects of local anesthetic agents on the uterine vasculatures and myometrium
Study date
1976
Auth party contact address
-
Data no
289148
Title
Study Report 3
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289122
Title
The welfare significance of the castration of cattle: A review
Study date
2005
Auth party contact address
-
Data no
288936
Title
App. 12: Method validation report
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288836
Title
Product specifications
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288905
Title
Preclinical safety assessment of antipyrine combined with lidocaine hydrochloride as ear drops
Study date
2019
Auth party contact address
-
Data no
288979
Title
App. 4: Analysis
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288956
Title
Behavioural and cortisol responses of lambs to castration and tailing using different methods
Study date
1996
Auth party contact address
-
Data no
289005
Title
App. 14: Statement
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289054
Title
Study Report 9 App Protocol
Study date
2022
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289128
Title
Topical anaesthesia alleviates short-term pain of castration and tail docking in lambs
Study date
2010
Auth party contact address
-
Data no
288856
Title
In-process controls
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288985
Title
Study report 16
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288999
Title
App. 9: Validation Report
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289048
Title
Study Report 17 App 16
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288942
Title
No Significant Risk Level (NSRL) for the Proposition 65 carcinogen 2,6-xylidine
Study date
2002
Auth party contact address
-
Data no
288948
Title
CVMP Opinion
Study date
2015
Auth party contact address
-
Data no
288842
Title
Risk assessment
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288893
Title
Changes in the antibody response with reference to prolonged treatment with local anaesthetics
Study date
1966
Auth party contact address
-
Data no
288991
Title
App. 2: Specification
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289042
Title
Study Report 17 App 8A
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289091
Title
Committee for Veterinary Medicinal Products - Lidocaine - Summary Report
Study date
1999
Auth party contact address
-
Data no
288945
Title
Extralabel use of tranquilizers and general anesthetics
Study date
1997
Auth party contact address
-
Data no
288922
Title
Final report on the safety assessment of substances
Study date
1982
Auth party contact address
-
Data no
289039
Title
Study Report 17 App 5
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288899
Title
Neurotoxicity of intrathecal local anaesthetics in rabbits
Study date
1985
Auth party contact address
-
Data no
289062
Title
Study Report 16 App 5
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288876
Title
Reproductive and teratogenic effects of lidocaine in sprague-dawley rats
Study date
1986
Auth party contact address
-
Data no
289085
Title
Biocompatibility of natural latex implanted into dental alveolus of rats
Study date
2006
Auth party contact address
-
Data no
288853
Title
Product development report
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289108
Title
Analgesic Synergy between Topical Lidocaine and Topical Opioids
Study date
2000
Auth party contact address
-
Data no
289131
Title
Validation of a method for assessment of an acute pain in lambs
Study date
2002
Auth party contact address
-
Data no
289022
Title
Study Report 1
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288916
Title
Epicutaneous substance sensitization induces T helper 2-type dermatitis and strong prohevein-specific IgE response
Study date
2003
Auth party contact address
-
Data no
288928
Title
App. 17: Approval SI
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288962
Title
Hazardous Substance Fact Sheet
Study date
2006
Auth party contact address
-
Data no
289114
Title
Pain in the weeks following surgical and rubber ring castration in dairy calves
Study date
2021
Auth party contact address
-
Data no
289068
Title
Study Report 16 App 15
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288968
Title
Maximum Residue Limits in Great Britain
Study date
2022
Auth party contact address
-
Data no
289051
Title
Assessment of the Pharmacokinetics and Pharmacodynamics of Injectable Lidocaine and a Lidocaine-Impregnated Latex Band for Castration and Tail Docking in Lambs
Study date
2024
Auth party contact address
-
Data no
289074
Title
Lidocaine VIN
Study date
2017
Auth party contact address
-
Data no
289145
Title
Study Report 2 App 2
Study date
2021
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288839
Title
Part 2 dossier
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288859
Title
Verification report 2
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289025
Title
PubChem 1
Study date
2024
Auth party contact address
-
Data no
289031
Title
The Use of Lidocaine-Infused Castration Bands to Castrate Beef?Dairy Calves and Its Effect on Animal Welfare and Performance
Study date
2025
Auth party contact address
-
Data no
289102
Title
Subarachnoid butorphanol augments lidocaine sensory anaesthesia in calves
Study date
2006
Auth party contact address
-
Data no
288959
Title
Influence of local anaesthesia on pain and distress induced by two bloodless castration methods in young lambs
Study date
2006
Auth party contact address
-
Data no
289002
Title
App. 11: Attestation
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289008
Title
App. 3: Facility description
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289125
Title
Does local anaesthetic reduce pain in rubber ring castration of neonatal lambs?
Study date
2024
Auth party contact address
-
Data no
288908
Title
Compound summary
Study date
2024
Auth party contact address
-
Data no
288982
Title
App. 7: Bioanalytical Report
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288833
Title
GMP 1
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288882
Title
Adverse effects of maternally administered lidocaine on the asphyxiated preterm fetal lamb
Study date
1989
Auth party contact address
-
Data no
288939
Title
Analytical Method Procedure Sheep
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289045
Title
Study Report 17 App 11
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289082
Title
Natural rubber latex-based biomaterials for drug delivery and regenerative medicine: Trends and directions
Study date
2024
Auth party contact address
-
Data no
289094
Title
Lidocaine Pharmacokinetics in Pregnant and Nonpregnant Sheep
Study date
1980
Auth party contact address
-
Data no
288902
Title
Toxicity of lidocaine in adult, newborn, and fetal sheep
Study date
1981
Auth party contact address
-
Data no
288988
Title
App. 17: Approval QA
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289137
Title
Toxicity of Lidocaine in Adult, Newborn, and Fetal Sheep
Study date
1981
Auth party contact address
-
Data no
288896
Title
Electrocorticographic description of the effects of anticonvulsant drugs used to treat lidocaine-induced seizures
Study date
2020
Auth party contact address
-
Data no
288845
Title
Test method 2
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289040
Title
Study Report 17 App 6
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289063
Title
Study Report 16 App 6
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288923
Title
Part 5A dossier
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289086
Title
Evidence in Practice of Tissue Healing with Latex Biomembrane: Integrative Review
Study date
2019
Auth party contact address
-
Data no
288900
Title
Toxicity of local anaesthetic agents
Study date
2013
Auth party contact address
-
Data no
289109
Title
Naloxone prolongs cutaneous nociceptive block by lidocaine in rats
Study date
2017
Auth party contact address
-
Data no
288877
Title
Relationship of fetal bradycardia to maternal administration of lidocaine in sheep
Study date
1979
Auth party contact address
-
Data no
289132
Title
Acute cortisol responses of lambs to ring castration and docking after the injection of lignocaine into the scrotal neck or testes at the time of ring application
Study date
1999
Auth party contact address
-
Data no
288854
Title
Certificates of analysis
Study date
2022
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288831
Title
Advice 3
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288963
Title
Risk assessment of lidocaine residues in food products from cattle, swine, sheep and goats: withdrawal periods for meat and milk
Study date
2005
Auth party contact address
-
Data no
289117
Title
Assessment of the Effective Tissue Concentrations of Injectable Lidocaine and a Lidocaine-Impregnated Latex Band for Castration in Calves
Study date
2024
Auth party contact address
-
Data no
289057
Title
Study Report 16
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289069
Title
Study Report 16 App 16
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289023
Title
Method Report 1
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288871
Title
Summary of toxicological studies - active
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288971
Title
App. 9: Validation Report
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288917
Title
Evaluation of percutaneous penetration of natural proteins
Study date
2000
Auth party contact address
-
Data no
289017
Title
Analytical Method Procedure Cattle
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288934
Title
App. 10: Bioanalytical report
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288840
Title
Validation protocol
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288911
Title
Murine models for natural substance allergy assessment
Study date
2002
Auth party contact address
-
Data no
289097
Title
Pharmacokinetics of Lidocaine in Nonpregnant and Pregnant Ewes
Study date
1988
Auth party contact address
-
Data no
289146
Title
Study Report 2 App 3
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288954
Title
Toxicology and Carcinogenesis studies of 2,6-xylidine (2,6-dimethylaniline) (CAS No. 87-62-7) in Charles River CD Rats (feed studies)
Study date
1990
Auth party contact address
-
Data no
288960
Title
Forward and reverse dosimetry for aniline and 2,6-dimethylaniline in humans extrapolated from humanized-liver mouse data using simplified physiologically based pharmacokinetic models
Study date
2022
Auth party contact address
-
Data no
289126
Title
PSX-29 Lidobands for Use in Lambs
Study date
2023
Auth party contact address
-
Data no
288860
Title
Part 3 dossier
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288977
Title
App. 2: Specification
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288983
Title
App. 8: CVs
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289026
Title
PubChem 2
Study date
2024
Auth party contact address
-
Data no
288834
Title
GMP 2
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289003
Title
App. 12: Attestation
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289077
Title
Pharmacokinetics of lidocaine in serum and milk of mature Holstein cows
Study date
2009
Auth party contact address
-
Data no
289103
Title
The Analgesic Response to Intravenous Lidocaine in the Treatment of Neuropathic Pain
Study date
1996
Auth party contact address
-
Data no
289034
Title
Study Report 17
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289046
Title
Study Report 17 App 14
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288891
Title
Inhibitory effect of membrane-binding drugs on excision repair of DNA damage in UV-irradiated Escherichia coli
Study date
1983
Auth party contact address
-
Data no
288903
Title
Toxicity of lidocaine in the fetal and newborn lamb and its relationship to asphyxia
Study date
1971
Auth party contact address
-
Data no
288940
Title
Validation Report Sheep
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288997
Title
App. 14: Calculations
Study date
2003
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289083
Title
Recent advances and perspectives on natural latex serum and its fractions for biomedical applications
Study date
2023
Auth party contact address
-
Data no
288848
Title
Verification report
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289089
Title
Pharmacokinetics of Lidocaine in Fetal and Neonatal Lambs and Adult Sheep
Study date
1979
Auth party contact address
-
Data no
289140
Title
Handbook of Pharmaceutical Excipients
Study date
2024
Auth party contact address
-
Data no
288874
Title
Cytotoxicity of lidocaine or bupivicaine on corneal endothelial cells in a rabbit model
Study date
2006
Auth party contact address
-
Data no
288897
Title
Lidocaine depolarizes the mitochondrial membrane potential by intracellular alkalization in rat dorsal root ganglion neurons
Study date
2011
Auth party contact address
-
Data no
288851
Title
Certificates of analysis
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288868
Title
Safety data sheet - 2
Study date
2016
Auth party contact address
-
Data no
288880
Title
Prolonged exposure to lidocaine disturbs preimplantation mouse embryo development
Study date
1996
Auth party contact address
-
Data no
289106
Title
Development and Field Validation of Lidocaine-Loaded Castration Bands for Bovine Pain Mitigation
Study date
2020
Auth party contact address
-
Data no
288914
Title
Proteins from Calotropis procera: Toxicity and immunological tolerance revisited
Study date
2017
Auth party contact address
-
Data no
288974
Title
App. 12: Approval SI
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289060
Title
Study Report 16 App 3
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289120
Title
Acute and chronic pain in calves after different methods of rubber-ring castration
Study date
2012
Auth party contact address
-
Data no
289014
Title
Report Lidocaine Residues
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289020
Title
Part 7 dossier
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288920
Title
Cytotoxicity of orthodontic elastomeric ligatures on L929 mouse fibroblasts
Study date
2010
Auth party contact address
-
Data no
289066
Title
Study Report 16 App 9
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288957
Title
Can Lambs in Pain Identify Medicated Feed?
Study date
2021
Auth party contact address
-
Data no
289123
Title
The most important local anesthetics in cattle: An overview
Study date
2003
Auth party contact address
-
Data no
289100
Title
Percutaneous Penetration of Local Anesthetic Bases: Pharmacodynamic Measurements
Study date
1999
Auth party contact address
-
Data no
288888
Title
Lidocaine potentiation of bleomycin A2 cytotoxicity and DNA strand breakage in L1210 and human A-253 cells
Study date
1985
Auth party contact address
-
Data no
289149
Title
Study Report 3 App Protocol
Study date
2022
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289006
Title
App. 1: Protocol
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289080
Title
Utility of lidocaine as a topical analgesic and improvements in patch delivery systems
Study date
2020
Auth party contact address
-
Data no
288857
Title
Method suitability report
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288931
Title
App. 2: Specification
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288980
Title
App. 5: Pathological findings
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288951
Title
Effects of Acute Pain Reduction Methods on the Chronic Inflammatory Lesions and Behaviour of Lambs Castrated and Tail Docked with Rubber Rings at less than Two Days of Age
Study date
2000
Auth party contact address
-
Data no
289129
Title
Influence of local anaesthesia on pain and distress induced by two bloodless castration methods in young lambs
Study date
2006
Auth party contact address
-
Data no
289000
Title
App. 9: Validation Report Addendum
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288937
Title
App. 12: Addendum
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288986
Title
App. 15: Custody record
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289037
Title
Study Report 17 App 3
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289043
Title
Study Report 17 App 8B
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289143
Title
Study Report 2
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288994
Title
App. 11: CVs
Study date
2022
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288894
Title
The convulsant potency of lidocaine and its n-dealkylated metabolites
Study date
1973
Auth party contact address
-
Data no
288943
Title
Primary aromatic amines in indoor dust from 10 countries and associated human exposure
Study date
2021
Auth party contact address
-
Data no
288898
Title
Lidocaine toxicity in primary afferent neurons from the rat
Study date
1998
Auth party contact address
-
Data no
288969
Title
Label
Study date
2021
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288946
Title
CVMP EPMAR
Study date
2021
Auth party contact address
-
Data no
288852
Title
Stability report
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288875
Title
Effects of commercial (pH ~3.5) and freshly prepared (pH ~6.5) lidocaine-adrenaline solutions of tissue pH
Study date
1982
Auth party contact address
-
Data no
288829
Title
Advice 1
Study date
2022
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288975
Title
App. 13: Approval QA
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288915
Title
Substance sensitization by dermal exposure can lead to airway hyperreactivity
Study date
2002
Auth party contact address
-
Data no
289009
Title
App. 4: Analysis
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289021
Title
VICH GL6
Study date
2023
Auth party contact address
-
Data no
289061
Title
Study Report 16 App 4
Study date
2022
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289015
Title
Report calculation - Cattle
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288869
Title
Safety data sheet - 3
Study date
2016
Auth party contact address
-
Data no
289115
Title
Unmitigated Surgical Castration in Calves of Different Ages: Cortisol Concentrations, Heart Rate Variability, and Infrared Thermography Findings
Study date
2021
Auth party contact address
-
Data no
288981
Title
App. 6: Data summary
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289052
Title
Study Report 8
Study date
2022
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288909
Title
Summary table of toxicology studies - excipient
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288958
Title
Castration of lambs: A welfare comparison of different castration techniques in lambs over 10 weeks of age
Study date
2007
Auth party contact address
-
Data no
289075
Title
Lidocaine Metabolism: Pathophysiology, Drug Interactions, and Surgical Implications
Study date
2004
Auth party contact address
-
Data no
289124
Title
Effect of ketoprofen, lidocaine local anesthesia, and combined xylazine and lidocaine caudal epidural anesthesia during castration of beef cattle on stress responses, immunity, growth, and behavior
Study date
2003
Auth party contact address
-
Data no
288883
Title
Effect of age on local anaesthetic central nervous system toxicity in mice
Study date
1983
Auth party contact address
-
Data no
289001
Title
App. 10: Custody Record
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289032
Title
Study Report 2305
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288932
Title
App. 3: Facility description
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289101
Title
Comparison of the application of lidocaine, lidocaine-dexamethasone and lidocaine-epinephrine for caudal epidural anesthesia in cows
Study date
2018
Auth party contact address
-
Data no
288952
Title
Further investigations into the genotoxicity of 2,6-xylidine and one of its key metabolites
Study date
2012
Auth party contact address
-
Data no
289081
Title
Drug-Eluting Rubber Bands for Tissue Ligation
Study date
2022
Auth party contact address
-
Data no
288938
Title
Validation Report Cattle
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289095
Title
AAWSG for Sheep
Study date
2016
Auth party contact address
-
Data no
288889
Title
A weight of evidence assessment of the genotoxicity of 2,6-xylidine based on existing and new data, with relevance to safety of lidocaine exposure
Study date
2021
Auth party contact address
-
Data no
288895
Title
Effect of local anaesthetics on human natural killer cell activity
Study date
1983
Auth party contact address
-
Data no
289138
Title
Study Report 1
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289144
Title
Study Report 2 App 1
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288989
Title
Letter
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288995
Title
App. 12: Validation Report
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289038
Title
Study Report 17 App 4
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288846
Title
Test method 3
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289064
Title
Study Report 16 App 7
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289135
Title
Letter of Attestation
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289112
Title
Effects of castration on behaviour and plasma cortisol concentrations in young lambs, kids and calves
Study date
1991
Auth party contact address
-
Data no
288849
Title
Validation report
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288855
Title
Specifications
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288832
Title
Meeting notes
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289058
Title
Study Report 16 App 1
Study date
2022
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289118
Title
Objective Measures for the Assessment of Post-Operative Pain in Bos indicus Bull Calves Following Castration
Study date
2017
Auth party contact address
-
Data no
288926
Title
App. 15: Custody record
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289012
Title
App. 7: Bioanalytical report
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289072
Title
EPMAR
Study date
2024
Auth party contact address
-
Data no
288966
Title
DNA Adduct Formation by 2,6-Dimethyl-, 3,5-Dimethyl-, and 3-Ethylaniline in Vivo in Mice
Study date
2006
Auth party contact address
-
Data no
288972
Title
App. 10: Custody Record
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288866
Title
LidoBand Castration Bands
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288872
Title
EPMAR - porcine
Study date
2024
Auth party contact address
-
Data no
289018
Title
Part 5B dossier
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288918
Title
Substance-induced dermal and pulmonary hypersensitivity in rabbits
Study date
1994
Auth party contact address
-
Data no
288886
Title
Chemical carcinogenesis studies in mouse epidermal cell cultures
Study date
1981
Auth party contact address
-
Data no
289147
Title
Study Report 2 App Protocol
Study date
2021
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288935
Title
App. 11: CVs
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289098
Title
The Influence of a Right-to-left Cardiac Shunt on Lidocaine Pharmacokinetics
Study date
1987
Auth party contact address
-
Data no
288863
Title
Toxicological information: dermal absorption
Study date
2023
Auth party contact address
-
Data no
288912
Title
Immunological responses of mice following administration of proteins by different routes of exposure
Study date
2000
Auth party contact address
-
Data no
289121
Title
Effect of local anaesthesia on short- and long-term pain induced by two bloodless castration methods in calves
Study date
2007
Auth party contact address
-
Data no
288978
Title
App. 3: Facility description
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289049
Title
Study Report 17 App 17
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289055
Title
Study Report 14
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288835
Title
GMP 3
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288929
Title
App. 18: Approval QA
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289104
Title
Onset and duration of hypoalgesia of lidocaine spray applied to oral mucosa - a dose response study
Study date
1992
Auth party contact address
-
Data no
288906
Title
Ocular toxicity following topical application of anesthetic cream to the eyelid skin
Study date
1996
Auth party contact address
-
Data no
288955
Title
Long-term hyperalgesia and traumatic neuroma formation in tail-docked lambs
Study date
2019
Auth party contact address
-
Data no
289029
Title
Part 8 dossier
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289078
Title
Pharmacokinetics of an intravenous constant rate infusion of a morphine-lidocaine-ketamine combination in Holstein calves undergoing umbilical herniorrhaphy
Study date
2019
Auth party contact address
-
Data no
289127
Title
Three Studies Evaluating the Potential for Lidocaine, Bupivacaine or Procaine to Reduce Pain-Related Behaviors following Ring Castration and/or Tail Docking in Lambs
Study date
2021
Auth party contact address
-
Data no
288892
Title
A study of the mutagenicity of anesthetics and their metabolites
Study date
1978
Auth party contact address
-
Data no
289141
Title
Allergic contact dermatitis of bovine teat skin caused by milking machine cluster rubber
Study date
2004
Auth party contact address
-
Data no
288949
Title
Concentrations of dimethylaniline and other metabolites in milk and tissues of dairy cows treated with lidocaine
Study date
2015
Auth party contact address
-
Data no
288998
Title
Study report 24
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289035
Title
Study Report 17 App 1
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289084
Title
AAWSG for Cattle
Study date
2016
Auth party contact address
-
Data no
288843
Title
Report determination
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289092
Title
Hepatic and Renal Clearances of Lidocaine in Conscious and Anesthetized Sheep
Study date
1986
Auth party contact address
-
Data no
288992
Title
App. 3: Facility description
Study date
2022
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289041
Title
Study Report 17 App 7
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288921
Title
Biocompatability studies of substances from different tree clones and collection methods
Study date
2014
Auth party contact address
-
Data no
289136
Title
Toxicity of lidocaine in the fetal and newborn lamb and its relationship to asphyxia
Study date
1972
Auth party contact address
-
Data no
288850
Title
Report recovery
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288927
Title
App. 16: Approval SD
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289107
Title
Potentiation of epidural lidocaine by co-administering tramadol by either intramuscular or epidural route in cats
Study date
2015
Auth party contact address
-
Data no
289119
Title
Anesthetic effects of different volumes of lidocaine for spermatic cord block in cattle
Study date
2017
Auth party contact address
-
Data no
288961
Title
NIOSH Summary
Study date
1994
Auth party contact address
-
Data no
288973
Title
App. 11: Approval SD
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289059
Title
Study Report 16 App 2
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288913
Title
In vitro neuronal cytotoxicity of orthodontic elastics
Study date
2004
Auth party contact address
-
Data no
289067
Title
Study Report 16 App 11
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289013
Title
App. 8: CVs
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288867
Title
Safety data sheet - 1
Study date
2024
Auth party contact address
-
Data no
289113
Title
Effect of band and knife castration of beef calves on welfare indicators of pain at three relevant industry ages: II. Chronic pain
Study date
2017
Auth party contact address
-
Data no
288967
Title
The long and short of it: A review of tail docking in farm animals
Study date
2011
Auth party contact address
-
Data no
289099
Title
Pharmacokinetics and pharmacodynamics of lignocaine: A review
Study date
2015
Auth party contact address
-
Data no
288864
Title
Effects of substance binary enhancers on in vitro transport of estradiol in human epidermis: a methanistic evaluation
Study date
2008
Auth party contact address
-
Data no
288887
Title
A new culture model facilitating rapid quantitative testing of mitotic spindle inhibition in mammalian cells
Study date
1976
Auth party contact address
-
Data no
288907
Title
Influence of topical anesthetics on oculocardiac reflex and corneal healing in rabbits
Study date
2010
Auth party contact address
-
Data no
289073
Title
A producer's guide to sheep husbandry practices
Study date
2022
Auth party contact address
-
Data no
289079
Title
In vitro metabolism of lidocaine in subcellular post-mitochondrial fractions and precision cut slices from cattle liver
Study date
2021
Auth party contact address
-
Data no
289007
Title
App. 2: Specifications
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289050
Title
Study Report 17 App 18
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289056
Title
Study Report 14 App Protocol
Study date
2022
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288858
Title
Verification report 1
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289030
Title
A guide to best practice husbandry in beef cattle
Study date
2023
Auth party contact address
-
Data no
288881
Title
The placental transfer of bupivicaine and lidocaine and their myocardial and cerebral uptake in the rabbit
Study date
1973
Auth party contact address
-
Data no
288930
Title
App. 1: Study protocol 17
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288987
Title
App. 16: Approval SD
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289093
Title
Risk assessment of lidocaine residues in food products from cattle, swine, sheep and goats: withdrawal periods for meat and milk
Study date
2005
Auth party contact address
-
Data no
289130
Title
Intra-articular lidocaine plus bupivacaine in sheep undergoing stifle arthrotomy
Study date
2004
Auth party contact address
-
Data no
289142
Title
Final Report on the Safety Assessment of Myristyl Myristate and Isopropyl Myristate
Study date
1982
Auth party contact address
-
Data no
288950
Title
IARC monograph
Study date
1993
Auth party contact address
-
Data no
289036
Title
Study Report 17 App 2
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289044
Title
Study Report 17 App 9
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288944
Title
Variability in Urinary Concentrations of Primary Aromatic Amines
Study date
2022
Auth party contact address
-
Data no
288844
Title
Test method 1
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288993
Title
App. 10: Bioanalytical Report
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288970
Title
Study report 22
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289087
Title
Lidocaine DrugBank
Study date
2025
Auth party contact address
-
Data no
288947
Title
Direct detection of glucuronide metabolites of lidocaine in sheep urine
Study date
2018
Auth party contact address
-
Data no
289110
Title
Synergistic Effects of Serotonin or Dopamine Combined With Lidocaine at Producing Nociceptive Block in Rats
Study date
2017
Auth party contact address
-
Data no
288924
Title
Study report 17
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289133
Title
Reduction in Pain Suffered by Lambs at Castration
Study date
1997
Auth party contact address
-
Data no
288830
Title
Advice 2
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288901
Title
Effect of procaine, carbocain and xylocaine on cutaneous muscle in rabbits and mice
Study date
1959
Auth party contact address
-
Data no
288878
Title
Toxicological assessment of lidocaine in the pregnant rat
Study date
1985
Auth party contact address
-
Data no
289070
Title
Study Report 16 App 17
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288964
Title
Welfare outcomes of calves of two ages castrated by rings
Study date
2012
Auth party contact address
-
Data no
288976
Title
App. 1: Protocol
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289024
Title
Method Report 2
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289010
Title
App. 5: Pathology report
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288870
Title
EPMAR - bovine
Study date
2021
Auth party contact address
-
Data no
289116
Title
Effect of meloxicam and lidocaine administered alone or in combination on indicators of pain and distress during and after knife castration in weaned beef calves
Study date
2018
Auth party contact address
-
Data no
289016
Title
Report calculation - Lambs
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288910
Title
Evaluation of cytotoxicity, oral toxicity, genotoxicity, and mutagenicity of the substance extracted from Himanthus drasticus (Mart.) Plumel (Apocynaceae)
Study date
2020
Auth party contact address
-
Data no
289076
Title
Pharmacokinetics of lidocaine after intravenous administration to cows
Study date
2011
Auth party contact address
-
Data no
288933
Title
App. 6: Analysis
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288861
Title
Cytochrome P450-mediated drug interactions affecting lidocaine
Study date
2009
Auth party contact address
-
Data no
288984
Title
The residues of lignocaine in sheep
Study date
2018
Auth party contact address
-
Data no
288884
Title
Transfer of lidocaine across the sheep placenta to the placenta. Hemodynamic and acid-base responses of the fetal lamb
Study date
1975
Auth party contact address
-
Data no
288953
Title
A weight of evidence assessment of the genotoxicity of 2,6-xylidine based on existing and new data, with relevance to safety of lidocaine exposure
Study date
2021
Auth party contact address
-
Data no
289027
Title
PubChem 3
Study date
2024
Auth party contact address
-
Data no
289004
Title
App. 13: Attestation
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289053
Title
Study Report 9
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288904
Title
Lidocaine, 2-chlorprocaine and hepatic necrosis
Study date
1966
Auth party contact address
-
Data no
289033
Title
Study Report 2305 CV
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289047
Title
Study Report 17 App 15
Study date
2024
Auth party contact address
7226 107 Ave Calgary Canada
Data no
289096
Title
Pharmacokinetics of sulphobromophthalein, lidocaine and indocyanine green in the course of subclinical fascioliasis in sheep
Study date
1987
Auth party contact address
-
Data no
288990
Title
App. 1: Protocol
Study date
2022
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288996
Title
App. 13: Validation Report
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288841
Title
Packaging
Study date
2025
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288847
Title
Specification report
Study date
2023
Auth party contact address
7226 107 Ave Calgary Canada
Data no
288890
Title
Determining the DNA-modifying activity of chemicals using DNA-polymerase-deficient Escherichia coli
Study date
1980
Auth party contact address
-
Data no
288941
Title
Trade Advice Notice on lignocaine and bupivacaine in the product Tri-Solfen Wound Anaesthetic & Antiseptic Solution for use on sheep
Study date
2023
Auth party contact address
-
Data no
289090
Title
Utility of lidocaine as a topical analgesic and improvements in patch delivery systems
Study date
2020
Auth party contact address
-
Data no
289139
Title
Study Report 1 App Protocol
Study date
2021
Auth party contact address
7226 107 Ave Calgary Canada
Date
Application Date
Application No
Application Number
149226
Product/Active constituent Name
Application Product Name
Ceftiofur hydrochloride
Application Date
Application Number
149226
Application Product Name
Ceftiofur hydrochloride
Application details
Product name:
Ceftiofur hydrochloride
Active name:
Ceftiofur hydrochloride
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Approval of ceftiofur hydrochloride for use in veterinary chemical products.
Description of data provided:
Data no
289338
Title
ASMF Ceftiofur hydrochloride
Study date
Jun 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Data no
289339
Title
CoA's Ceftiofur hydochloride
Study date
Nov 2023
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Date
Application Date
Application No
Application Number
148686
Product/Active constituent Name
Application Product Name
Storm Ultra Rodenticide
Application Date
Application Number
148686
Application Product Name
Storm Ultra Rodenticide
Application details
Product name:
Storm Ultra Rodenticide
Product number:
96259
Applicant Name:
BASF AUSTRALIA LTD.
Application purpose and description of use:
Registration of a 0.025 g/kg flocoumafen ready-to-use bait (RB) used for the control of rats and mice in and around industrial, commercial, agricultural and domestic buildings. Controls rats and mice resistant to warfarin.
Reference details:
54191 - STORM SECURE WAX BLOCK RODENTICIDE
80663 - Storm Soft Bait Rodenticide
Active constituents:
Active constituent name
65328 - FLOCOUMAFEN
Description of data provided:
Data no
287817
Title
Comparison of Days to Death Following Choice Feeding (Palatability) Studies on Storm?? Ultra Bait (BAS 322 20 I) and Storm Block Bait (BAS 322 05 I) Rodenticide Baits Against Rattus norvegicus and Mus musculus.
Study date
Mar 2019
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
287823
Title
Comparison of Days to Death Following Pen Trial Studies on Storm?? Ultra Bait (BAS 322 20 I) and Storm Block Bait (BAS 322 05 I) Rodenticide Baits Against Wild-Derived Mus musculus.
Study date
Apr 2019
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
287811
Title
Part 6 Worker Health & Safety - Summary
Study date
June 2025
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
287803
Title
Part 2 Chemistry & Manufacture - Summary
Study date
Jun 2025
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
287820
Title
Choice Feeding (Palatability) Study on Heat Stressed (Post one Week at 77??C) Storm?? Ultra Secure (BAS 322 20 I) Against Male Rattus norvegicus.
Study date
Feb 2019
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
287814
Title
Part 8 Efficacy - Summary
Study date
June 2025
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
287806
Title
Additional validation of Analytical Method AFL0199/04 for the Determination of Active Ingredient in BAS 322 20 I.
Study date
Jun 2015
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
287821
Title
Comparison of Choice Feeding (Palatability) Studies on Storm?? Ultra Bait (BAS 322 20 I) Against Competitor Rodenticide Baits using Rattus norvegicus and Mus musculus.
Study date
Feb 2019
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
287809
Title
Physical and Chemical Properties of BAS 322 20 I: Accelerated Storage Stability for up to 156 weeks at 25??C stored in flexible bags.
Study date
Nov 2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
287815
Title
Comparison of The Cumulative Amount of Bait Ingested During Choice Feeding (Palatability) Studies on Storm?? Ultra (BAS 322 20 I) and Storm Secure (BAS 322 05 I) Rodenticide Block Baits Against Male and Female Rattus norvegicus.
Study date
Apr 2019
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
287818
Title
CHOICE FEEDING (PALATABILITY) TESTS ON 25ppm Flocoumafen Block Bait, Storm?? Ultra (No Luconyl dye), AGAINST male Wister Han Rats.
Study date
Nov 2024
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
287812
Title
The In Vitro Percutaneous Absorption of Radiolabelled Flocoumafen in the Block Bait Formulation BAS 322 20 I Through Human Split-Thickness Skin
Study date
Apr 2022
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
287804
Title
Document J - Confidential Data and Information
Study date
May 2025
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
287813
Title
Part 7 Environmenatal Safety - Summary
Study date
June 2025
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
287807
Title
Physical and Chemical Properties of BAS 322 20 I: Accelerated Storage Stability for up to 2 weeks at 54??C stored in flexible bags.
Study date
Jan 2020
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
287810
Title
Physical and Chemical Properties of BAS 322 20 I: Storage Stability for 104 weeks at 25??C stored in a polypropylene bucket.
Study date
Jul 2017
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
287808
Title
Physical and Chemical Properties of BAS 322 20 I: Storage Stability for up to 2 weeks at 54??C stored in a stand-up pouch made from Polyethylene terephthalate (PET)/Polyethylene (PEE)(12/80um)
Study date
Apr 2020
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
287819
Title
Choice Feeding (Palatability) Study on Fresh and Cold Stressed (Post One Week At -18??C) Storm?? Ultra Secure (BAS 322 20 I) Against Male Rattus norvegicus.
Study date
Feb 2019
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
287805
Title
Validation of the Analytical Method AFL0199/04 HPLC method for the determination of BAS 322 07 I. Weatherhead P. Aug 2011.
Study date
Aug 2011
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
287822
Title
Effect of Extreme Heat (77??C) on Storm?? Ultra Secure Bait (BAS 322 20 I) and Five Competitor Wax Block Baits.
Study date
Feb 2019
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Data no
287816
Title
Comparison of Mould Stability of Storm?? Ultra (BAS 322 20 I) and Storm?? 4G (BAS 322 05 I) Block Baits at High Temperature (35??C) and High Humidity (???90%RH).
Study date
Apr 2019
Auth party contact address
Level 23 40 City Road SOUTHBANK Australia
Date
Application Date
Application No
Application Number
148772
Product/Active constituent Name
Application Product Name
Albaugh Zipper 200 Herbicide
Application Date
Application Number
148772
Application Product Name
Albaugh Zipper 200 Herbicide
Application details
Product name:
Albaugh Zipper 200 Herbicide
Product number:
81319
Applicant Name:
ALBAUGH AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of product registration to vary registered particulars.
Reference details:
66314 - GENFARM GLUFOSINATE 200 HERBICIDE
Active constituents:
Active constituent name
61903 - GLUFOSINATE-AMMONIUM
Description of data provided:
Data no
287992
Title
Albaugh Zipper Bioequivalence Fallow Report 2024
Study date
10 Jan 2025
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
287986
Title
SDS for Non-Active Constituents
Study date
Mar 2021
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
287989
Title
Dilution Stability & Persistent foam report
Study date
May 2025
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
287987
Title
Manufacturing process
Study date
May 2025
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
287984
Title
Executive summary
Study date
June 2025
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
287990
Title
Method Validation Study Report
Study date
Jan 2016
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
287993
Title
Albaugh Zipper bioequivalence Duboisia 2025 report
Study date
12 Mar 2025
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
287988
Title
Physico-Chemical Study Report
Study date
March 2016
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
287985
Title
Chemistry Dossier_Albaugh Zipper
Study date
June 2025
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Data no
287991
Title
Efficacy Dossier_Albaugh Zipper 200 Herbicide_02june25
Study date
June 2025
Auth party contact address
Level 1, 530 Little Collins Street MELBOURNE Australia
Date
Application Date
Application No
Application Number
149062
Product/Active constituent Name
Application Product Name
Monepantel
Application Date
Application Number
149062
Application Product Name
Monepantel
Application details
Product name:
Monepantel
Active name:
Monepantel
Applicant Name:
AGRO-ALLIANCE (AUSTRALIA) PTY LTD
Application purpose and description of use:
Approval of Monepantel for use in veterinary chemical products.
Description of data provided:
Data no
288046
Title
Specification
Study date
2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
288040
Title
Manufacturer
Study date
2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
288052
Title
Stability date
Study date
2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
288043
Title
control of critical steps and intermediates
Study date
2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
288049
Title
Batch analysis
Study date
2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
288044
Title
Elucidation of Structure
Study date
2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
288038
Title
Certificates of analysis
Study date
08/2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
288050
Title
Stability summary and conclusion
Study date
2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
289295
Title
Container Closure System
Study date
2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
288041
Title
manuf-process-and-controls
Study date
2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
288047
Title
Analytical procedures
Study date
2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
288042
Title
Control of materials
Study date
2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
288039
Title
General Information
Study date
2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
288053
Title
cGMP statement
Study date
2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
288048
Title
Analytical Method Validation
Study date
2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
288045
Title
Impurities
Study date
2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia
Data no
288051
Title
Post approval stability protocol and stability commitment
Study date
2025
Auth party contact address
11 CONDOR STREET HAWTHORN EAST Australia