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
144428
Product/Active constituent Name
Application Product Name
Disodium Copper EDTA
Application Date
Application Number
144428
Application Product Name
Disodium Copper EDTA
Application details
Product name:
Disodium Copper EDTA
Active name:
Disodium Copper EDTA
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Approval of Disodium Copper EDTA for use in veterinary products.
Description of data provided:
Data no
273030
Title
Part 2 - Chemistry & Manufacture
Study date
June 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Date
Application Date
Application No
Application Number
144338
Product/Active constituent Name
Application Product Name
TITAN Treflan Herbicide
Application Date
Application Number
144338
Application Product Name
TITAN Treflan Herbicide
Application details
Product name:
TITAN Treflan Herbicide
Product number:
87108
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Variation of product registration to add a new formulation and new formulation sites to the product's registration details.
Active constituents:
Active constituent name
45746 - TRIFLURALIN
Active constituent name
48271 - TRIFLURALIN
Active constituent name
59597 - TRIFLURALIN
Active constituent name
56169 - TRIFLURALIN
Description of data provided:
Data no
272635
Title
Chemistry and manufacture of Titan Trifluralin 480 EC
Study date
29 May 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
272633
Title
Titan Treflan Part 2 Chemistry and Manufacture
Study date
31 May 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
272634
Title
Manufacturers' specifications for the non-active constituents of Titan Treflan Herbicide
Study date
31 May 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
272636
Title
Storage stability of Titan Trifluralin 480 EC
Study date
17 May 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
272632
Title
Titan Treflan AA letter
Study date
31 May 2024
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
144412
Product/Active constituent Name
Application Product Name
FLUBENDIAMIDE
Application Date
Application Number
144412
Application Product Name
FLUBENDIAMIDE
Application details
Product name:
FLUBENDIAMIDE
Active name:
FLUBENDIAMIDE
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of Flubendiamide for use in agricultural chemical products.
Description of data provided:
Data no
272975
Title
Analysis Method for Flubendiamide Technical
Study date
09/05/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
272977
Title
Five Batch Analysis of Flubendiamide Technical - Study No 0022.C42.001.22
Study date
05/09/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
272974
Title
Method of Manufacture - Flubendiamide Tech
Study date
20/04/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
272976
Title
Declaration of Composition (DoC) - Flubendiamide Technical
Study date
10/05/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
272978
Title
Certificate of Analysis (CoA) - Flubendiamide Technical
Study date
Oct 2021
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
272979
Title
MSDS for Flubendiamide Technical
Study date
2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
272973
Title
PART 1 - EXECUTIVE SUMMARY; PART 2 - CHEMISTRY & MANUFACTURE SUMMARY
Study date
12/06/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
272980
Title
Letter of Support / Authorisation from Source - Flubendiamide Technical
Study date
20/04/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date
Application Date
Application No
Application Number
144424
Product/Active constituent Name
Application Product Name
Disodium Manganese EDTA
Application Date
Application Number
144424
Application Product Name
Disodium Manganese EDTA
Application details
Product name:
Disodium Manganese EDTA
Active name:
Disodium Manganese EDTA
Applicant Name:
VIRBAC (AUSTRALIA) PTY LTD
Application purpose and description of use:
Approval of Disodium Manganese EDTA for use in veterinary products.
Description of data provided:
Data no
273013
Title
Part 2 - Chemistry & Manufacture
Study date
June 2024
Auth party contact address
361 HORSLEY ROAD MILPERRA Australia
Date
Application Date
Application No
Application Number
144257
Product/Active constituent Name
Application Product Name
Spinosad
Application Date
Application Number
144257
Application Product Name
Spinosad
Application details
Product name:
Spinosad
Active name:
Spinosad
Applicant Name:
SINON AUSTRALIA PTY LIMITED
Application purpose and description of use:
Approval of spinosad for use in agricultural chemical products.
Description of data provided:
Data no
271884
Title
Five batches of Technical Grade Active Ingredient (TGAI) Study No: U303 Min-Chang Sinon Central Laboratory February 9, 2022
Study date
9 February 2022
Auth party contact address
Level 7 60 York Street SYDNEY Australia
Data no
271885
Title
Amended pages to SNCL Report No: U303
Study date
31 May 2022
Auth party contact address
Level 7 60 York Street SYDNEY Australia
Data no
271882
Title
Manufacturing Process
Study date
May 2022
Auth party contact address
Level 7 60 York Street SYDNEY Australia
Data no
271883
Title
Declaration of Composition
Study date
2024
Auth party contact address
Level 7 60 York Street SYDNEY Australia
Data no
271881
Title
Part 2 Chemistry and Manufacture
Study date
24 May 2024
Auth party contact address
Level 7 60 York Street SYDNEY Australia
Data no
271886
Title
IN VITRO MAMMALIAN CHROMOSOMAL ABERRATION TEST OF SPINOSAD 92% TECH IN HUMAN LYMPHOCYTES
Study date
3 November 2021
Auth party contact address
Level 7 60 York Street SYDNEY Australia
Data no
271887
Title
BACTERIAL REVERSE MUTATION TEST OF SPINOSAD 92% TECH USING SALMONELLA TYPHIMURIUM AND ESCHERICHIA COLI TESTER STRAINS
Study date
4 February 2022
Auth party contact address
Level 7 60 York Street SYDNEY Australia
Date
Application Date
Application No
Application Number
144414
Product/Active constituent Name
Application Product Name
Ethpyri Fungicide
Application Date
Application Number
144414
Application Product Name
Ethpyri Fungicide
Application details
Product name:
Ethpyri Fungicide
Product number:
94996
Applicant Name:
Shandong Rainbow International Co Ltd
Application purpose and description of use:
Registration of an 600 g/L Pyrimethanil in Suspension Concentrate (SC) formulation product for the control of grey mould (Botrytis cinerea) in grapevines, strawberries and tolerant ornamental species, yellow sigatoka, leaf speckle and cordana leaf spot in bananas and target spot in potatoes and tomatoes as per the Directions for Use
Reference details:
89974 - Campbell Pyper 600SC Fungicide
Active constituents:
Active constituent name
93424 - Pyrimethanil
Description of data provided:
Data no
272984
Title
RAWS Portfolio
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
272986
Title
analytical method and validation
Study date
2023
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
272982
Title
Formulation process, Specs, CoA
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
272985
Title
Low Temperature stability
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
272981
Title
Chemistry dossier
Study date
07/11/2023
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
272983
Title
Accelerated Storage Stability Study on Pyrimethanil 600G/L SC
Study date
September 15, 2023
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
272989
Title
Product label
Study date
2024
Auth party contact address
-
Data no
272990
Title
Pyrimethanil 600 SC in Banana
Study date
5/6/2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
272991
Title
Evaluation of Ethpyri 600SC fungicide for control of Grey Mould in Strawberry
Study date
May 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
272987
Title
Efficacy dossier
Study date
22/03/2023
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
272988
Title
Reference product Label and SDS
Study date
22/03/2023
Auth party contact address
-
Data no
272992
Title
Excutive summary and Additional Arguments
Study date
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
144398
Product/Active constituent Name
Application Product Name
Propyzamide
Application Date
Application Number
144398
Application Product Name
Propyzamide
Application details
Product name:
Propyzamide
Active name:
Propyzamide
Applicant Name:
AGOCEANIA PTY LTD
Application purpose and description of use:
Approval of Propyzamide for use in agricultural chemical products.
Description of data provided:
Data no
272881
Title
Five Batch of Propyzamide Technical-Agrifor-2016
Study date
April 1, 2016
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
272884
Title
DoC of Propyzamide TC
Study date
May 20, 2024
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
272887
Title
The statement of batch size of Propyzamide technical in 5-batch report
Study date
May 20, 2024
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
272882
Title
MANUFACTURE PROCESS OF PROPYZAMIDE TECHNICAL
Study date
May 20, 2024
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
272883
Title
The Justification of Impurities of Propyzamide TC-final
Study date
May 20, 2024
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
272885
Title
Physical and chemical properties of Propyzamide
Study date
May 20, 2024
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
272886
Title
Registration Data of Propyzamide
Study date
May 20, 2024
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Date
Application Date
Application No
Application Number
144399
Product/Active constituent Name
Application Product Name
Chlorantraniliprole
Application Date
Application Number
144399
Application Product Name
Chlorantraniliprole
Application details
Product name:
Chlorantraniliprole
Active name:
Chlorantraniliprole
Applicant Name:
AGOCEANIA PTY LTD
Application purpose and description of use:
Approval of Chlorantraniliprole for use in agricultural chemical products.
Description of data provided:
Data no
272890
Title
The statement of batch size of Chlorantraniliprole technical in 5-batch report
Study date
May 20, 2024
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
272888
Title
Five Batch report of Chlorantraniliprole Technical
Study date
Dec. 21, 2020
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
272889
Title
Manufacture Process and The Justification of Impurities of Chlorantraniliprole Technical
Study date
May 20, 2024
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
272891
Title
DoC of Chlorantraniliprole TC
Study date
May 20, 2024
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
272892
Title
Physical and chemical properties of Chlorantraniliprole
Study date
May 20, 2024
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Data no
272893
Title
Registration Data of Chlorantraniliprole
Study date
May 20, 2024
Auth party contact address
U106 24-26 Dumaresq Street Gordon Australia
Date
Application Date
Application No
Application Number
143964
Product/Active constituent Name
Application Product Name
Equibactin Oral Paste for Horses
Application Date
Application Number
143964
Application Product Name
Equibactin Oral Paste for Horses
Application details
Product name:
Equibactin Oral Paste for Horses
Product number:
62149
Applicant Name:
DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.
Application purpose and description of use:
Variation to product registration and label approval.
Active constituents:
Active constituent name
85855 - TRIMETHOPRIM
Active constituent name
85795 - SULFADIMIDINE
Description of data provided:
Data no
279288
Title
s159 Notice - response
Study date
04 October 2024
Auth party contact address
2 Cal Close Somersby Australia
Data no
271538
Title
Module 2.4
Study date
April 2024
Auth party contact address
2 Cal Close Somersby Australia
Data no
271539
Title
Degradation Analysis
Study date
April 2024
Auth party contact address
2 Cal Close Somersby Australia
Data no
271540
Title
Stability Tables
Study date
16 December 2013
Auth party contact address
2 Cal Close Somersby Australia
Date
Application Date
Application No
Application Number
144283
Product/Active constituent Name
Application Product Name
PREVICOX 57MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN & INFLAMMATION CONTROL
Application Date
Application Number
144283
Application Product Name
PREVICOX 57MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN & INFLAMMATION CONTROL
Application details
Product name:
PREVICOX 57MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN & INFLAMMATION CONTROL
Product number:
58093
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Variation of product registration to remove a manufacture site.
Variation of product label approval to align with global product label.
Description of data provided:
Data no
271946
Title
Eudra GMP Certificate
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271943
Title
Summary of Product Characteristics QRDv8
Study date
23 March 2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271944
Title
Summary of Product Characteristics QRDv9
Study date
23 October 2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271945
Title
58093_additional marketing label - draft
Study date
27 May 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date
Application Date
Application No
Application Number
144284
Product/Active constituent Name
Application Product Name
PREVICOX 227MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN & INFLAMMATION CONTROL FOR DOGS
Application Date
Application Number
144284
Application Product Name
PREVICOX 227MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN & INFLAMMATION CONTROL FOR DOGS
Application details
Product name:
PREVICOX 227MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN & INFLAMMATION CONTROL FOR DOGS
Product number:
57941
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Variation of product registration to remove a manufacture site.
Variation of product label approval to align with global product label.
Description of data provided:
Data no
271952
Title
Eudra GMP Certificate
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
276781
Title
Registrant's Declaration
Study date
21 August 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271950
Title
Summary of Product Characteristics QRDv8
Study date
30 March 2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
271951
Title
Summary of Product Characteristics QRDv9
Study date
23 October 2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date
Application Date
Application No
Application Number
144323
Product/Active constituent Name
Application Product Name
Cobalt EDTA
Application Date
Application Number
144323
Application Product Name
Cobalt EDTA
Application details
Product name:
Cobalt EDTA
Active name:
Cobalt EDTA
Applicant Name:
ABBEY LABORATORIES PTY LTD
Application purpose and description of use:
The purpose of this application is to approve active constituent Cobalt EDTA for use in our veterinary chemical
products.
Description of data provided:
Data no
272341
Title
Active chemistry dossier
Study date
June 24
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
272342
Title
Active chemistry dossier V1
Study date
June 24
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Date
Application Date
Application No
Application Number
144370
Product/Active constituent Name
Application Product Name
TRISTAR-M ORAL DRENCH FOR SHEEP
Application Date
Application Number
144370
Application Product Name
TRISTAR-M ORAL DRENCH FOR SHEEP
Application details
Product name:
TRISTAR-M ORAL DRENCH FOR SHEEP
Product number:
94979
Applicant Name:
VETPHARM LABORATORIES IP PTY LTD
Application purpose and description of use:
Registration of a 40 g/L levamisole hydrochloride, 25 g/L albendazole, 1 g/L moxidectin oral drench product for the treatment and control of sensitive strains of gastrointestinal nematodes in sheep.
Reference details:
83241 - Tridectin 3-Way Oral Drench For Sheep
Active constituents:
Active constituent name
85141 - MOXIDECTIN
Active constituent name
82829 - MOXIDECTIN
Active constituent name
84023 - LEVAMISOLE HYDROCHLORIDE
Active constituent name
84847 - ALBENDAZOLE
Description of data provided:
Data no
272678
Title
Product specifications
Study date
2024
Auth party contact address
7/20 St Johns Avenue GORDON Australia
Data no
277682
Title
Product specifications
Study date
2024
Auth party contact address
7/20 St Johns Avenue GORDON Australia
Date
Application Date
Application No
Application Number
143884
Product/Active constituent Name
Application Product Name
Primo Maxx HG Turf Growth Regulator
Application Date
Application Number
143884
Application Product Name
Primo Maxx HG Turf Growth Regulator
Application details
Product name:
Primo Maxx HG Turf Growth Regulator
Product number:
94862
Applicant Name:
SYNGENTA AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 120 g/L/ trinexapac-ethyl, micro emulsion product for regulation of leaf and stem growth of grass species and as an aid in turf management.
Reference details:
83378 - QUALI-PRO Marvel Ultra Plant Growth Regulator
Active constituents:
Active constituent name
64693 - TRINEXAPAC-ETHYL
Description of data provided:
Data no
271814
Title
Letter of Support (LoS) and Manufacturer?s Declaration
Study date
30 Mar 2024
Auth party contact address
Holder of confidential commercial information
Date
Application Date
Application No
Application Number
144334
Product/Active constituent Name
Application Product Name
BIXAFEN
Application Date
Application Number
144334
Application Product Name
BIXAFEN
Application details
Product name:
BIXAFEN
Active name:
BIXAFEN
Applicant Name:
IMTRADE AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of Bixafen for use in agricultural chemical products.
Description of data provided:
Data no
272595
Title
Analysis Method for Bixafen 98% TC
Study date
2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
272597
Title
Five Batch Analysis of Bixafen Technical - Study No 0161
Study date
23/09/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
272594
Title
Method of Manufacture - Bixafen Tech
Study date
20/07/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
272596
Title
Declaration of Composition (DoC) - Bixafen
Study date
25/07/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
272598
Title
Certificate of Analysis (CoA) - Bixafen Technical
Study date
2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
272599
Title
MSDS for Bixafen 98%TC
Study date
2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
272593
Title
PART 1 - EXECUTIVE SUMMARY; PART 2 - CHEMISTRY & MANUFACTURE SUMMARY
Study date
31/05/2024
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Data no
272600
Title
Letter of Support / Authorisation from Source - Bixafen 98% TC
Study date
30/08/2023
Auth party contact address
SUITE 22, 11 PRESTON ST COMO Australia
Date
Application Date
Application No
Application Number
144255
Product/Active constituent Name
Application Product Name
MATE ORAL PROGESTAGEN FOR PIGS
Application Date
Application Number
144255
Application Product Name
MATE ORAL PROGESTAGEN FOR PIGS
Application details
Product name:
MATE ORAL PROGESTAGEN FOR PIGS
Product number:
94937
Applicant Name:
Aurora Pharmaceutical, Inc
Application purpose and description of use:
Registration of a 4 mg/mL altrenogest oral solution product for the programming of oestrus in sexually mature gilts and primiparous sows intended for breeding.
Reference details:
45680 - REGUMATE ORAL PROGESTAGEN FOR PIGS
Active constituents:
Active constituent name
91850 - Altrenogest
Description of data provided:
Data no
276615
Title
Product specifications
Study date
2024
Auth party contact address
1196 Hwy. 3 South Northfield United States
Data no
278401
Title
Product specifications
Study date
2024
Auth party contact address
1196 Hwy. 3 South Northfield United States
Data no
271889
Title
Product specification
Study date
2024
Auth party contact address
1196 Hwy. 3 South Northfield United States
Data no
271891
Title
Declaration
Study date
2024
Auth party contact address
1196 Hwy. 3 South Northfield United States
Data no
272585
Title
GMP certificate
Study date
2024
Auth party contact address
1196 Hwy. 3 South Northfield United States
Data no
271890
Title
Report
Study date
2024
Auth party contact address
1196 Hwy. 3 South Northfield United States
Data no
276616
Title
Product list
Study date
2024
Auth party contact address
1196 Hwy. 3 South Northfield United States
Data no
276617
Title
GMP certificate
Study date
2024
Auth party contact address
1196 Hwy. 3 South Northfield United States
Data no
276618
Title
GMP declaration
Study date
2024
Auth party contact address
1196 Hwy. 3 South Northfield United States
Date
Application Date
Application No
Application Number
143318
Product/Active constituent Name
Application Product Name
TRI-SOLFEN WOUND ANAESTHETIC & ANTISEPTIC SOLUTION
Application Date
Application Number
143318
Application Product Name
TRI-SOLFEN WOUND ANAESTHETIC & ANTISEPTIC SOLUTION
Application details
Product name:
TRI-SOLFEN WOUND ANAESTHETIC & ANTISEPTIC SOLUTION
Product number:
88635
Applicant Name:
DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.
Application purpose and description of use:
Variation of product registration and label approval to extend use pattern, vary approved pack sizes and make minor amendments to Relevant Label Particulars.
Active constituents:
Active constituent name
85040 - Lignocaine hydrochloride
Active constituent name
85034 - BUPIVACAINE HYDROCHLORIDE
Active constituent name
84636 - Adrenaline Acid Tartrate
Active constituent name
85146 - CETRIMIDE
Description of data provided:
Data no
269190
Title
Interim stability data
Study date
2024
Auth party contact address
2 Cal Close Somersby Australia
Data no
269175
Title
Trial AE01-05: Dose Determination Study on a Topical Local Anaesthetic Preparation for Use in Sheep
Study date
2005
Auth party contact address
2 Cal Close Somersby Australia
Data no
269176
Title
Trial AE03-05: A Field Study to Evaluate the Safety and Efficacy of a Topical Local Anaesthetic Spray for Use in Sheep
Study date
2005
Auth party contact address
2 Cal Close Somersby Australia
Data no
269177
Title
Impact of topical anaesthesia on pain alleviation and wound healing in lambs after mulesing.
Study date
2008
Auth party contact address
-
Data no
269183
Title
AETC21203W: Safety and efficacy of Tri-Solfen when applied to cutaneous wounds in dogs - pilot study.
Study date
2023
Auth party contact address
2 Cal Close Somersby Australia
Data no
269184
Title
AETC22178W: Safety and efficacy of Tri-Solfen when applied to cutaneous wounds in dogs.
Study date
2023
Auth party contact address
2 Cal Close Somersby Australia
Data no
269253
Title
Topical Wound Anaesthesia in Children--a Temporary Postoperative Pain Relief.
Study date
1999
Auth party contact address
-
Data no
269180
Title
AECALFDBE1: Initial field trials to examine efficacy of topical anaesthesia for pain alleviation in dairy calves post disbudding / dehorning.
Study date
2017
Auth party contact address
2 Cal Close Somersby Australia
Data no
269185
Title
Part 8 summary
Study date
2024
Auth party contact address
2 Cal Close Somersby Australia
Data no
269186
Title
Part IV - Pre-Clinical and Clinical Documentation: gc-part IV-dogs-v5.0
Study date
2024
Auth party contact address
2 Cal Close Somersby Australia
Data no
269187
Title
Part IV.3.2 Rationale for Dosage / concentration: gd-432-dose devt-v1.1
Study date
2024
Auth party contact address
2 Cal Close Somersby Australia
Data no
269188
Title
Part IV.3.3 Target Animal Safety: gd-433-TAS-v1.1
Study date
2024
Auth party contact address
2 Cal Close Somersby Australia
Data no
269189
Title
Nocita FOI Summary FDA
Study date
2016
Auth party contact address
-
Data no
269191
Title
Reference list
Study date
2024
Auth party contact address
2 Cal Close Somersby Australia
Data no
269192
Title
Meta-Analysis: Does Lidocaine Gel before Flexible Cystoscopy Provide Pain Relief?
Study date
2009
Auth party contact address
-
Data no
269193
Title
Principles of Office Anaesthesia Part II: Topical Anaesthesia
Study date
2002
Auth party contact address
-
Data no
269194
Title
Bupivacaine: morphological effects on spinal cords of cats and durations of spinal anesthesia in sheep.
Study date
1977
Auth party contact address
-
Data no
269195
Title
Spinal anesthesia in sheep with local anesthetic solutions at pH 4 and pH 7
Study date
1984
Auth party contact address
-
Data no
269196
Title
THE COMPARATIVE POTENCY AND EFFECTIVENESS OF TOPICAL ANAESTHETICS IN MAN
Study date
1964
Auth party contact address
-
Data no
269197
Title
Postoperative Pain Relief Using Wound Infiltration With 0.5% Bupivacaine in Single- Incision Laparoscopic Surgery for an Appendectomy
Study date
2013
Auth party contact address
-
Data no
269198
Title
Wound Infiltration with Bupivacaine versus Ketorolac for Postoperative Pain Relief in Minor to Moderate Surgeries
Study date
2009
Auth party contact address
-
Data no
269199
Title
Onset of 1% Lidocaine for Skin Infiltrative Anaesthesia
Study date
2005
Auth party contact address
-
Data no
269200
Title
A Pharmacokinetic Study of a Topical Anaesthetic (EMLA) in Mouse Soft Tissue Laceration
Study date
2012
Auth party contact address
-
Data no
269201
Title
Blood Concentration of Prilocaine and Lidocaine after the Use of Topical Anaesthesia (Oraqix) in Lacerated Wounds
Study date
2016
Auth party contact address
-
Data no
269202
Title
Review of Lidocaine/Tetracaine Cream as a Topical Anaesthetic for Dermatologic Laser Procedures
Study date
2013
Auth party contact address
-
Data no
269203
Title
Trial of three methods of intraoperative bupivacaine analgesia for pain after paediatric groin surgery
Study date
1997
Auth party contact address
-
Data no
269204
Title
The Effect of Concentration on Vasoactivity of Bupivacaine and Lidocaine
Study date
1976
Auth party contact address
-
Data no
269205
Title
Time to Onset of Analgesia Following Local Infiltration of Liposome Bupivacaine in Healthy Volunteers: A Randomised, Single- Blind, Sequential Cohort, Crossover Study
Study date
2013
Auth party contact address
-
Data no
269206
Title
Effect of Epinephrine on Lidocaine Clearance In Vivo A Microdialysis Study in Humans
Study date
1999
Auth party contact address
-
Data no
269207
Title
THE SYSTEMIC ABSORPTION OF LOCAL ANALGESIC DRUGS
Study date
1965
Auth party contact address
-
Data no
269208
Title
Topical Lidocaine in the Treatment of Partial-Thickness Burns.
Study date
1989
Auth party contact address
-
Data no
269209
Title
Onset and Duration of Hypoalgesia Following Application of Lidocaine Spray on Genital Mucosa
Study date
1994
Auth party contact address
-
Data no
269210
Title
Epidural Anaesthesia with Lidocaine and Bupivacaine: Effects of Epinephrine on the Plasma Concentration Profiles
Study date
1986
Auth party contact address
-
Data no
269211
Title
Effects of Oral Meloxicam and Topical Lidocaine on Pain associated Behaviors of Piglets Undergoing Surgical Castration
Study date
2019
Auth party contact address
-
Data no
269212
Title
Evaluation of the Population Pharmacokinetic Properties of Lidocaine and Its Metabolites After Long-Term Multiple Applications of a Lidocaine Plaster in Post-Herpetic Neuralgia Patients
Study date
2017
Auth party contact address
-
Data no
269213
Title
Differential Onset of Median Nerve Block: Randomised, Double-Blind Comparison of Mepivacaine and Bupivacaine in Healthy Volunteers
Study date
1998
Auth party contact address
-
Data no
269214
Title
Evaluation of Intraperitoneal and Incisional Lidocaine or Bupivacaine for Analgesia Following Ovariohysterectomy in the Dog
Study date
2004
Auth party contact address
-
Data no
269215
Title
Systemic Absorption of Topical Lidocaine in Normal Volunteers, Patients with Post-Herpetic Neuralgia, and Patients with Acute Herpes Zoster
Study date
2002
Auth party contact address
-
Data no
269216
Title
A comparison between bupivacaine instillation versus ilioinguinal/iliohypogastric nerve block for postoperative analgesia following inguinal herniorrhaphy in children
Study date
1990
Auth party contact address
-
Data no
269217
Title
The effect of local/topical analgesics on incisional pain in a pig model.
Study date
2017
Auth party contact address
-
Data no
269218
Title
Pharmacokinetics of Lidocaine Hydrochloride Administered with or without Epinephrine for the Paravertebral Brachial Plexus Block in Dogs
Study date
2017
Auth party contact address
-
Data no
269219
Title
Onset and Duration of Intradermal Mixtures of Bupivacaine and Lidocaine with Epinephrine
Study date
2013
Auth party contact address
-
Data no
269220
Title
Pharmacology of Local Anaesthetic Agents
Study date
1986
Auth party contact address
-
Data no
269221
Title
The incidence and severity of complications and pain following periodontal surgery
Study date
1986
Auth party contact address
-
Data no
269222
Title
Effects of a topically applied anaesthetic on the behaviour, pain sentisitvity and weight gain of dairy calves following thermocautery disbudding with a local anaesthetic.
Study date
2019
Auth party contact address
-
Data no
269223
Title
A Comparison of the Pharmacodynamics and Pharmacokinetics of Bupivacaine, Ropivacaine (with Epinephrine) and Their Equal Volume Mixtures with Lidocaine Used for Femoral and Sciatic Nerve Blocks: A Double-Blind Randomised Study
Study date
2009
Auth party contact address
-
Data no
269224
Title
Urethral Anaesthesia with Topical Bupivacaine. A Role for a Longer-Acting Agent
Study date
1995
Auth party contact address
-
Data no
269225
Title
The Effect of a Topical Anaesthetic on the Sensitivity of Calf Dehorning Wounds.
Study date
2013
Auth party contact address
-
Data no
269226
Title
Evaluating the efficacy of a topical anaesthetic formulation and ketoprofen, alone and in combination on the pain sensitivity of dehorning wounds in Holstein-Friesian calves.
Study date
2015
Auth party contact address
-
Data no
269227
Title
Anaesthetic Properties and Toxicity of Bupivacaine and Lidocaine for Infiltration Anaesthesia.
Study date
1987
Auth party contact address
-
Data no
269228
Title
Treatment of acute systemic toxicity after the rapid intravenous injection of ropivacaine and bupivacaine in the conscious dog.
Study date
1991
Auth party contact address
-
Data no
269229
Title
Comparative local anesthetic efficacy and pharmacokinetics of epidurally administered ropivacaine and bupivacaine in the sheep.
Study date
1997
Auth party contact address
-
Data no
269230
Title
Pharmacokinetic and Clinical Effects of Two Bupivacaine Concentrations on Axillary Brachial Plexus Block.
Study date
2018
Auth party contact address
-
Data no
269231
Title
Time to Analgesia Onset and Pharmacokinetics After Separate and Combined Administration of Liposome Bupivacaine and Bupivacaine HCl: Considerations for Clinicians.
Study date
2016
Auth party contact address
-
Data no
269232
Title
Pharmacokinetics and Safety of Continuously Applied Lidocaine Patches 5%.
Study date
2002
Auth party contact address
-
Data no
269233
Title
A Double-Blind Randomised Controlled Trial Investigating the Effectiveness of Topical Bupivacaine in Reducing Distress in Children Following Extractions under General Anaesthesia.
Study date
2004
Auth party contact address
-
Data no
269234
Title
Penile Absorption of EMLA Cream in Piglets: Implications for Use of EMLA in Neonatal Circumcision.
Study date
1995
Auth party contact address
-
Data no
269235
Title
Differential Sensitivity of Fast and Slow Fibers in Mammalian Nerve. III. Effect of Etidocaine and Bupivacaine on Fast/Slow Fibers.
Study date
1982
Auth party contact address
-
Data no
269236
Title
Long-Acting Local Anaesthetics and Perioperative Pain Management.
Study date
2010
Auth party contact address
-
Data no
269237
Title
Pain alleviation during castration of piglets: a comparative study of different farm options.
Study date
2016
Auth party contact address
-
Data no
269238
Title
Effects of four analgesic treatments on the behavioural and cortisol responses of 3-week-old lambs to tail docking.
Study date
1997
Auth party contact address
-
Data no
269239
Title
Topical Bupivacaine for Pain Control Following Simple Dental Extractions.
Study date
1998
Auth party contact address
-
Data no
269240
Title
Lumb and Jones Veterinary Anesthesia and Analgesia.
Study date
2007
Auth party contact address
-
Data no
269241
Title
Veterinary Anesthesia and Analgesia: The Fifth Edition of Lumb and Jones.
Study date
2015
Auth party contact address
-
Data no
269242
Title
Topical Bupivacaine Compared to Bupivacaine Infiltration for Post-Tonsillectomy Pain Relief in Children: A Prospective Randomised Controlled Clinical Study.
Study date
2014
Auth party contact address
-
Data no
269243
Title
Effect of local anaesthesia and/or analgesia on pain responses induced by piglet castration.
Study date
2011
Auth party contact address
-
Data no
269244
Title
Assessment of Pain Induced by Castration in Piglets: Behavioral and Physiological Responses over the Subsequent 5 Days.
Study date
2003
Auth party contact address
-
Data no
269245
Title
Duration of Action of Bupivacaine Hydrochloride Used for Palatal Sensory Nerve Block in Infant Pigs.
Study date
2014
Auth party contact address
-
Data no
269246
Title
Evaluation of horn bud wound healing following cautery disbudding of pre-weaned dairy calves treated with aluminium-based aerosol bandage.
Study date
2017
Auth party contact address
-
Data no
269247
Title
Vasoconstrictors and Local Anaesthesia: A Review and Rationale for Use.
Study date
1983
Auth party contact address
-
Data no
269248
Title
Effect of Topical Local Anaesthetic Application to Skin Harvest Sites for Pain Management in Burn Patients Undergoing Skin-Grafting Procedures.
Study date
1999
Auth party contact address
-
Data no
269249
Title
Intravenous and Intra-Wound Local Anaesthesia.
Study date
2012
Auth party contact address
-
Data no
269250
Title
Continuous Local Anaesthetic Wound Infusion to Improve Postoperative Outcome Back to the Periphery?
Study date
2007
Auth party contact address
-
Data no
269251
Title
Topical Anaesthesia.
Study date
1998
Auth party contact address
-
Data no
269252
Title
Castration under anaesthesia and/or analgesia in commercial pig production.
Study date
2007
Auth party contact address
-
Data no
269254
Title
Lidocaine Patch (5%) Produces a Selective, but Incomplete Block of Ao and C Fibers.
Study date
2012
Auth party contact address
-
Data no
269255
Title
Cardiovascular and central nervous system effects of co-administered lidocaine and bupivacaine in piglets.
Study date
1991
Auth party contact address
-
Data no
269256
Title
Pharmacokinetics of Lidocaine with Epinephrine in Piglets Following Epidural Anaesthesia.
Study date
1996
Auth party contact address
-
Data no
269257
Title
Use of bupivacaine hydrochloride in oral surgery - clinical study.
Study date
1977
Auth party contact address
-
Data no
269258
Title
Triple-Blind Randomised Clinical Trial of Time Until Sensory Change Using 1.5% Mepivacaine With Epinephrine, 0.5% Bupivacaine, or an Equal Mixture of Both for Infraclavicular Block.
Study date
2012
Auth party contact address
-
Data no
269259
Title
Sheep: a model for testing spinal and epidural anesthetic agents.
Study date
1975
Auth party contact address
-
Data no
269261
Title
Efficacy of Continuous Wound Catheters Delivering Local Anesthetic for Postoperative Analgesia: A Quantitative and Qualitative Systematic Review of Randomized Controlled Trials.
Study date
2006
Auth party contact address
-
Data no
269262
Title
Aspects of The Pharmacology of Local Anaesthetic Agents
Study date
1970
Auth party contact address
-
Data no
269263
Title
Assessment and amelioration of pain for improved welfare during routine husbandry procedures in piglets.
Study date
2015
Auth party contact address
-
Data no
269264
Title
Topical anaesthesia alleviates short-term pain of castration and tail docking in lambs.
Study date
2010
Auth party contact address
-
Data no
269265
Title
Topical anaesthesia reduces sensitivity of castration wounds in neonatal piglets.
Study date
2017
Auth party contact address
-
Data no
269266
Title
Impact of topical anaesthesia on pain alleviation and wound healing in lambs after mulesing.
Study date
2008
Auth party contact address
-
Data no
269267
Title
Duration of action of a topical anaesthesia formulation for pain management of mulesing in sheep.
Study date
2013
Auth party contact address
-
Data no
269268
Title
Topical anesthesia mitigates the pain of castration in beef calves.
Study date
2013
Auth party contact address
-
Data no
269269
Title
Comparison between Instillation of Bupivacaine versus Caudal Analgesia for Postoperative Analgesia Following Inguinal Herniotomy in Children.
Study date
2003
Auth party contact address
-
Data no
269270
Title
Systematic Review and Metaanalysis of Intraperitoneal Instillation of Local Anaesthetics for Reduction of Pain after Gynecologic Laparoscopy.
Study date
2012
Auth party contact address
-
Data no
269271
Title
Effect of topically applied anaesthetic formulation on the sensitivity of scoop dehorning wounds in calves.
Study date
2016
Auth party contact address
-
Data no
269272
Title
Intra-Oral Topical Anaesthetics: A Review.
Study date
2000
Auth party contact address
-
Data no
269273
Title
Is Amalgamated Ligno-Bupivacaine an Answer to Complicated Minor Oral Surgical Anaesthesia? A Randomised Split-Mouth Double-Blind Clinical Trial.
Study date
2018
Auth party contact address
-
Data no
269274
Title
Bupivacaine: a long-lasting local anaesthetic for dentistry.
Study date
1984
Auth party contact address
-
Data no
269275
Title
Toxicity of lidocaine in adult, newborn, and fetal sheep.
Study date
1981
Auth party contact address
-
Data no
269276
Title
Effect of Surgical Castration on the Behavioral and Acute Phase Responses of 5-Day-Old Piglets.
Study date
2008
Auth party contact address
-
Data no
269277
Title
Antiseptics and disinfectants: activity, action, and resistance.
Study date
1999
Auth party contact address
-
Data no
269278
Title
Local and general anesthetic effects on behavior and performance of two- and seven-week-old castrated and uncastrated piglets.
Study date
1988
Auth party contact address
-
Data no
269279
Title
5% Lidocaine Medicated Plaster for the Treatment of Postherpetic Neuralgia: A Review of the Clinical Safety and Tolerability.
Study date
2015
Auth party contact address
-
Data no
269280
Title
Clinical Trials with Bupivacaine in Oral Surgery.
Study date
1976
Auth party contact address
-
Data no
269281
Title
Vasoactive Characteristics of Bupivacaine and Levobupivacaine with and without Adjuvant Epinephrine in Peripheral Human Skin.
Study date
2005
Auth party contact address
-
Data no
269282
Title
Comparison of Lidocaine with and without Bupivacaine for Local Dental Anaesthesia.
Study date
1997
Auth party contact address
-
Data no
269283
Title
Topical Bupivacaine Compared to Lidocaine with Epinephrine for Post-Tonsillectomy Pain Relief in Children: A Randomised Controlled Study.
Study date
2011
Auth party contact address
-
Data no
269284
Title
The Effect of Addition of Lidocaine to Bupivacaine on Anaesthesia Beginning Time, Block Time, and Block Quality in Lateral Sagittal Infraclavicular Block.
Study date
2013
Auth party contact address
-
Data no
269285
Title
The Effect of a Topical Anaesthetic Formulation, Systemic Flunixin and Carprofen, Singly or in Combination, on Cortisol and Behavioral Responses of Merino Lambs to Mulesing.
Study date
2007
Auth party contact address
-
Data no
269286
Title
Antimicrobial drug resistance in Staphylococcus aureus isolated from cattle in Brazil.
Study date
1995
Auth party contact address
-
Data no
269287
Title
Epinephrine with Lidocaine for Digital Nerve Blocks.
Study date
2015
Auth party contact address
-
Data no
269288
Title
Use of continuous, local infusion of bupivacaine for post- operative analgesia in dogs undergoing total ear canal ablation.
Study date
2005
Auth party contact address
-
Data no
269289
Title
Distribution of Radioactive Lidocaine Injected into the Testes in Piglets.
Study date
2005
Auth party contact address
-
Data no
269290
Title
Comparison of 1% Lidocaine with 0.5% Bupivacaine in Digital Ring Blocks.
Study date
1987
Auth party contact address
-
Data no
269291
Title
Local Anaesthetics. Is There an Advantage to Mixing Solutions?
Study date
1996
Auth party contact address
-
Data no
269292
Title
Pharmacokinetic Compatibility Study of Lidocaine with EXPAREL in Yucatan Miniature Pigs.
Study date
2011
Auth party contact address
-
Data no
269293
Title
Evaluating the effect of quaternary ammonium disinfectants on bacterial strains of animal origin
Study date
2020
Auth party contact address
-
Data no
269294
Title
Resistance of Enterobacteriacea to preservatives and disinfectants.
Study date
1988
Auth party contact address
-
Data no
269295
Title
Hemodynamic and central nervous system effects of intravenous bolus doses of lidocaine, bupivacaine and ropivacaine in sheep.
Study date
1989
Auth party contact address
-
Data no
269296
Title
Safety and Efficacy Outcomes of Long-Term Treatment up to 4 Years with 5% Lidocaine Medicated Plaster in Patients with Post-Herpetic Neuralgia.
Study date
2012
Auth party contact address
-
Data no
269297
Title
Lidocaine pharmacokinetics and toxicity in newborn pigs.
Study date
1997
Auth party contact address
-
Data no
269298
Title
A Comparison of the Efficacy of Topical Application of Lidocaine Hydrochloride 5% Gel and Bupivacaine Hydrochloride 5% Gel for Extraction of Teeth.
Study date
2010
Auth party contact address
-
Data no
269299
Title
Mechanisms of Local Anaesthetics on Voltage-Gated Sodium and Other Ion Chammels.
Study date
2002
Auth party contact address
-
Data no
269300
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
269301
Title
Topical wound anaesthesia: efficacy to mitigate piglet castration pain.
Study date
2020
Auth party contact address
-
Data no
269302
Title
Topical Application of Lidocaine and Bupivacaine to Disbudding Wounds in Dairy Calves: Safety, Toxicology and Wound Healing.
Study date
2021
Auth party contact address
-
Data no
269303
Title
Effect of Different Epinephrine Concentrations on Local Bleeding and Hemodynamics during Dermatologic Surgery.
Study date
2008
Auth party contact address
-
Data no
269304
Title
Duration and Efficacy of Different Local Anesthetics on the Palmar Digital Nerve Block in Horses.
Study date
2015
Auth party contact address
-
Data no
269305
Title
On the Mechanism by Which Epinephrine Potentiates Lidocaine - Peripheral Nerve Block
Study date
2003
Auth party contact address
-
Data no
269306
Title
Local and Regional Anaesthesia in Ruminants and Swine.
Study date
1996
Auth party contact address
-
Data no
269307
Title
A Randomised Field Study Evaluating the Effectiveness of Buccal Meloxicam and Topical Local Anaesthetic Formulations Administered Singly or in Combination at Improving Welfare of Female Merino Lambs Undergoing Surgical Mulesing and Hot Knife Tail Docking.
Study date
2018
Auth party contact address
-
Data no
269308
Title
A Pen Study Evaluation of Buccal Meloxicam and Topical Anaesthetic at Improving Welfare of Lambs Undergoing Surgical Mulesing and Hot Knife Tail Docking.
Study date
2018
Auth party contact address
-
Data no
269309
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
269310
Title
Efficacy of precisely injected single local bolus of lignocaine for alleviation of behavioural responses to pain during tail docking and castration of lambs with rubber rings.
Study date
2020
Auth party contact address
-
Data no
269311
Title
Comparison of Topical Anaesthetics without Cocaine to Tetracaine- Epinephrine-Cocaine and Lidocaine Infiltration during Repair of Lacerations: Bupivacaine-Norepinephrine Is an Effective New Topical Anaesthetic Agent.
Study date
1996
Auth party contact address
-
Data no
269312
Title
Effects of Transdermal Lidocaine or Lidocaine with Prilocaine or Tetracaine on Mechanical Superficial Sensation and Nociceptive Thermal Thresholds in Horses.
Study date
2018
Auth party contact address
-
Data no
269313
Title
A Comparison of Bupivacaine Instillation and Inguinal Field Block for Control of Pain after Herniorrhaphy.
Study date
1992
Auth party contact address
-
Data no
269314
Title
Use of topical local anesthetics to control pain during treatment of hoof lesions in dairy cows.
Study date
2019
Auth party contact address
-
Data no
269315
Title
Comparison of two topical treatments on wound healing 7 days after disbudding of calves using thermocautery.
Study date
2020
Auth party contact address
-
Data no
269316
Title
Physiology and Behavior of Pigs before and after Castration: Effects of Two Topical Anaesthetics
Study date
2010
Auth party contact address
-
Data no
269317
Title
The efficacy of alternative methods of disbudding in calves.
Study date
2018
Auth party contact address
-
Data no
269318
Title
Effect of the Addition of a Vasoconstrictor to Local Anaesthetic Solution on Operative and Postoperative Bleeding, Analgesia and Wound Healing.
Study date
1979
Auth party contact address
-
Data no
269319
Title
Hypoalgesic Effect of EMLA and Lidocaine Gel Applied on Human Oral Mucosa: Quantitative Evaluation by Sensory and Pain Thresholds to Argon Laser Stimulation.
Study date
1992
Auth party contact address
-
Data no
269320
Title
THE DURATION OF ACTION OF BUPIVACAINE, PRILOCAINE AND LIDOCAINE.
Study date
1970
Auth party contact address
-
Data no
269321
Title
Intratunical Bupivacaine and Methylprednisolone Instillation for Scrotal Pain after Testicular Sperm Retrieval Procedures.
Study date
2003
Auth party contact address
-
Data no
269322
Title
Lidocaine Concentration in Oral Tissue by the Addition of Epinephrine.
Study date
2016
Auth party contact address
-
Data no
269323
Title
A bioadhesive delivery system as an alternative to infiltration anaesthesia.
Study date
1997
Auth party contact address
-
Data no
269324
Title
Local Anaesthetic Wound Infusion for Acute Postoperative Pain: A Viable Option?
Study date
2011
Auth party contact address
-
Data no
269325
Title
A Comparative Neuro-Histological Assessment of Gluteal Skin Thickness and Cutaneous Nociceptor Distribution in Horses and Humans.
Study date
2020
Auth party contact address
-
Data no
269326
Title
Comparison of Bupivacaine and Lidocaine/Bupivacaine for Local Anaesthesia/Digital Nerve Block.
Study date
1996
Auth party contact address
-
Data no
269327
Title
Effects of Topical Anaesthetic and Buccal Meloxicam on Average Daily Gain, Behavior and Inflammation of Unweaned Beef Calves Following Surgical Castration.
Study date
2018
Auth party contact address
-
Data no
269328
Title
Effects of Topical Anaesthetic and Buccal Meloxicam Treatments on Concurrent Castration and Dehorning of Beef Calves.
Study date
2018
Auth party contact address
-
Data no
269329
Title
Evaluating Treatments with Topical Anaesthetic and Buccal Meloxicam for Pain and Inflammation Caused by Amputation Dehorning of Calves.
Study date
2018
Auth party contact address
-
Data no
269330
Title
Pharmacokinetics and efficacy of a novel long-acting bupivacaine formulation for cornual nerve block in calves.
Study date
2022
Auth party contact address
-
Data no
269331
Title
Clinical Trial of a New Local Anaesthetic (LAC-43) With the Aid of the Pin-Prick and Ninhydrin Methods in Finger Blocks.
Study date
1964
Auth party contact address
-
Data no
269332
Title
Injectable Sodium Chloride as a Local Anaesthetic for Skin Surgery.
Study date
1979
Auth party contact address
-
Data no
269333
Title
Clinical Pharmacokinetics of Local Anaesthetics.
Study date
1977
Auth party contact address
-
Data no
269334
Title
Efficacy and Safety of a Lidocaine Gel in Patients from 6 Months up to 8 Years with Acute Painful Sites in the Oral Cavity: A Randomised, Placebo-Controlled, Double-Blind, Comparative Study.
Study date
2015
Auth party contact address
-
Data no
269335
Title
Behavioural alterations in piglets after surgical castration: Effects of analgesia and anaesthesia.
Study date
2019
Auth party contact address
-
Data no
269260
Title
Determination of the toxic dose of lidocaine in dogs and its corresponding serum concentration.
Study date
2007
Auth party contact address
-
Data no
269178
Title
Trial AE02-05: Safety evaluation on a topical local anaesthetic preparation for use in sheep.
Study date
2005
Auth party contact address
2 Cal Close Somersby Australia
Data no
269179
Title
AETO3161: Target animal safety study to confirm the safety of TRI-SOLFEN a topical anaesthetic and antiseptic solution for pain relief in lambs following mulesing, tail docking and during castration when applied at 1x, 3x and 5x the recommended dose level in lambs.
Study date
2016
Auth party contact address
2 Cal Close Somersby Australia
Data no
269181
Title
AETB17000N: Target animal safety study to confirm the safety of TRI-SOLFEN a topical anaesthetic and antiseptic solution for pain relief in calves following disbudding when applied (single application) at 1x the recommended dose level and (repeat applications) at 3x and 5x the recommended dose level.
Study date
2018
Auth party contact address
2 Cal Close Somersby Australia
Data no
269182
Title
Topical application of lidocaine and bupivacaine to disbudding wounds in dairy calves: safety, toxicology and wound healing.
Study date
2021
Auth party contact address
-
Data no
269174
Title
PAA 133231-mtg written advice-FINAL
Study date
2022
Auth party contact address
2 Cal Close Somersby Australia
Date
Application Date
Application No
Application Number
144308
Product/Active constituent Name
Application Product Name
CLOSANTEL BASE
Application Date
Application Number
144308
Application Product Name
CLOSANTEL BASE
Application details
Product name:
CLOSANTEL BASE
Active name:
CLOSANTEL BASE
Applicant Name:
ABBEY LABORATORIES PTY LTD
Application purpose and description of use:
Approval of active Closantel base for Veterinary Purpose.
Description of data provided:
Data no
272069
Title
Active chemistry dossier
Study date
May 24
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Date
Application Date
Application No
Application Number
143771
Product/Active constituent Name
Application Product Name
Alginate
Application Date
Application Number
143771
Application Product Name
Alginate
Application details
Product name:
Alginate
Active name:
Alginate
Applicant Name:
GLOBAL BUSINESS CORPORATION PTY LTD
Application purpose and description of use:
Approval of Alginate for use in agricultural chemical products.
Description of data provided:
Data no
271941
Title
Alginate
Study date
2024
Auth party contact address
26 Coonawarra Drive St Clair Australia
Date
Application Date
Application No
Application Number
144304
Product/Active constituent Name
Application Product Name
Linuron
Application Date
Application Number
144304
Application Product Name
Linuron
Application details
Product name:
Linuron
Active name:
Linuron
Applicant Name:
Shandong Rainbow International Co Ltd
Application purpose and description of use:
Approval of LinuronTechnical for use in agricultural chemical products.
Description of data provided:
Data no
272307
Title
Linuron Technical: Complete Analysis of Five Batch Samples-1
Study date
19/03/2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
272308
Title
Linuron Technical: Complete Analysis of Five Batch Samples-2
Study date
19/03/2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
272309
Title
Linuron Technical: Complete Analysis of Five Batch Samples-3
Study date
19/03/2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
272310
Title
Linuron Technical: Complete Analysis of Five Batch Samples-4
Study date
19/03/2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
272313
Title
Doc
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
272314
Title
2 5 The Statement of Batch Size of Spiroxamine Technical in 5-Batch Report
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
272311
Title
MANUFACTURE PROCESS OFLINURON TECHNICAL
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
272306
Title
Chemistry &Manufacturing Dossier
Study date
29/05/2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
272312
Title
THE JUSTIFICATION OF IMPURITIES OF LINURON TECHNICAL
Study date
2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China