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

145163
Product/Active constituent Name

Application Product Name

Skin2P Body

Application details

Product name:

Skin2P Body

Product number:

93559

Applicant Name:

CALLINGTON HAVEN PTY LTD

Application purpose and description of use:

Variation of product claims and label approval to "Up to 8 HOURS long lasting protection against mosquitoes Repels mosquitoes, flies, sandflies, ticks & other biting insects".

Reference details:

65744 - OFF! TROPICAL STRENGTH INSECT REPELLENT SPRAY

Active constituents:

Active constituent name
44493 - PICARIDIN
Date

Application Date

Application No

Application Number

145346
Product/Active constituent Name

Application Product Name

ACCENSI ABAMECTIN INSECTICIDE

Application details

Product name:

ACCENSI ABAMECTIN INSECTICIDE

Product number:

53080

Applicant Name:

ACCENSI PTY LTD

Application purpose and description of use:

Variation of label to amend unit of measurement and cancellation of selected non-statutory labels.

Active constituents:

Active constituent name
44497 - ABAMECTIN
Active constituent name
52801 - ABAMECTIN

Description of data provided:

Data no
278155
Author
Andrew O?Carrigan
Title
53080ELBL ACCENSI ABAMECTIN INSECTICIDE LABEL
Study date
10.09.2024
Authorising party
Applicant
Auth party contact address
Suite 201, Level 2 3 Rider Boulevard RHODES Australia
Data no
278156
Author
APVMA
Title
Invitation letter
Study date
04.09.2024
Authorising party
APVMA
Auth party contact address
APVMA
Date

Application Date

Application No

Application Number

145384
Product/Active constituent Name

Application Product Name

BIMECTIN ANTIPARASITIC INJECTION FOR CATTLE

Application details

Product name:

BIMECTIN ANTIPARASITIC INJECTION FOR CATTLE

Product number:

95371

Applicant Name:

BIMEDA (AUSTRALIA) PTY. LIMITED

Application purpose and description of use:

Registration of a 10 mg/mL ivermectin injectable product for the treatment and control of ivermectin sensitive internal and external parasites of cattle.

Reference details:

46570 - IVOMEC ANTIPARASITIC INJECTION FOR CATTLE

Active constituents:

Active constituent name
82759 - IVERMECTIN

Description of data provided:

Data no
277743
Author
Anon
Title
Product specifications
Study date
2024
Authorising party
Applicant
Auth party contact address
C/- KPMG, LEVEL 38,Tower Three International Towers 300 Barangaroo Avenue SYDNEY Australia
Data no
281171
Author
Anon
Title
Product specifications - Version 2
Study date
2024
Authorising party
Applicant
Auth party contact address
C/- KPMG, LEVEL 38,Tower Three International Towers 300 Barangaroo Avenue SYDNEY Australia
Data no
277744
Author
Anon
Title
GMP
Study date
2023
Authorising party
Applicant
Auth party contact address
C/- KPMG, LEVEL 38,Tower Three International Towers 300 Barangaroo Avenue SYDNEY Australia
Date

Application Date

Application No

Application Number

145109
Product/Active constituent Name

Application Product Name

BROMOTRIMIDINE PASTE

Application details

Product name:

BROMOTRIMIDINE PASTE

Product number:

46084

Applicant Name:

INTERNATIONAL ANIMAL HEALTH PRODUCTS PTY LTD

Application purpose and description of use:

Variation to approve additional pack size and vary manufacturing sites.

Active constituents:

Active constituent name
85585 - BROMHEXINE HYDROCHLORIDE
Active constituent name
85773 - SULPHADIMIDINE
Active constituent name
86033 - TRIMETHOPRIM

Description of data provided:

Data no
281189
Author
International Animal Health Products Pty Ltd
Title
Certificate of analysis
Study date
2022
Authorising party
Applicant
Auth party contact address
18 HEALEY CIRCUIT HUNTINGWOOD Australia
Data no
281190
Author
International Animal Health Products Pty Ltd
Title
Certificate of analysis
Study date
2022
Authorising party
Applicant
Auth party contact address
18 HEALEY CIRCUIT HUNTINGWOOD Australia
Data no
276677
Author
International Animal Health Products Pty Ltd
Title
Reference-2 Packaging specification of 500g Pack size
Study date
15/08/2024
Authorising party
Applicant
Auth party contact address
18 HEALEY CIRCUIT HUNTINGWOOD Australia
Data no
276678
Author
International Animal Health Products Pty Ltd
Title
Reference-3 Packaging specification of 1Kg Pack size
Study date
15/08/2024
Authorising party
Applicant
Auth party contact address
18 HEALEY CIRCUIT HUNTINGWOOD Australia
Data no
281186
Author
International Animal Health Products Pty Ltd
Title
IAHP Response - S159(1)(a) - Notice of requirement of information for Bromotrimdine Paste
Study date
26/11/24
Authorising party
Applicant
Auth party contact address
18 HEALEY CIRCUIT HUNTINGWOOD Australia
Data no
281187
Author
International Animal Health Products Pty Ltd
Title
Manufacturer details document
Study date
26/11/24
Authorising party
Applicant
Auth party contact address
18 HEALEY CIRCUIT HUNTINGWOOD Australia
Data no
281188
Author
APVMA
Title
APVMA approval document
Study date
26/11/24
Authorising party
APVMA
Auth party contact address
APVMA
Data no
276676
Author
International Animal Health Products Pty Ltd
Title
Reference-1 Risk assessment and justification for Bromotrimidine Paste 1kg Pack Size
Study date
15/08/2024
Authorising party
Applicant
Auth party contact address
18 HEALEY CIRCUIT HUNTINGWOOD Australia
Date

Application Date

Application No

Application Number

145243
Product/Active constituent Name

Application Product Name

Zinc Sulphate Monohydrate

Application details

Product name:

Zinc Sulphate Monohydrate

Active name:

Zinc Sulphate Monohydrate

Applicant Name:

ABBEY LABORATORIES PTY LTD

Application purpose and description of use:

The purpose of this application is to approve the active constituent Zinc Sulphate Monohydrate for use in our veterinary chemical products.

Description of data provided:

Data no
277235
Author
Abbey laboratories Pty Ltd
Title
Active chemistry dossier -1
Study date
Sep 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Data no
277236
Author
Abbey laboratories Pty Ltd
Title
Active chemistry dossier-2
Study date
Sep 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Date

Application Date

Application No

Application Number

145247
Product/Active constituent Name

Application Product Name

Cyromazine

Application details

Product name:

Cyromazine

Active name:

Cyromazine

Applicant Name:

ABBEY LABORATORIES PTY LTD

Application purpose and description of use:

The purpose of this application is to approve the active constituent cyromazine for use in our veterinary chemical products

Description of data provided:

Data no
277257
Author
Abbey laboratories Pty Ltd
Title
Active chemistry dossier
Study date
Sep 24
Authorising party
Applicant
Auth party contact address
Unit 27 1 Maitland Place Norwest Australia
Date

Application Date

Application No

Application Number

145294
Product/Active constituent Name

Application Product Name

Indoxacarb

Application details

Product name:

Indoxacarb

Active name:

Indoxacarb

Applicant Name:

Anhui Guangxin Agrochemical Co Ltd

Application purpose and description of use:

Approval of indoxacarb for use in agricultural chemical products.

Description of data provided:

Data no
277699
Author
Anhui Guangxin Agrochemical Co., Ltd.
Title
Qualitative and Quantitative Profile of the test substance Indoxacarb (Five Batch Analysis)_PART A
Study date
2024
Authorising party
Applicant
Auth party contact address
Pengcun village Xinhang Town Guangde County, Xuancheng City Anhui Province China
Data no
277700
Author
Anhui Guangxin Agrochemical Co., Ltd.
Title
Qualitative and Quantitative Profile of the test substance Indoxacarb (Five Batch Analysis)_PART B
Study date
2024
Authorising party
Applicant
Auth party contact address
Pengcun village Xinhang Town Guangde County, Xuancheng City Anhui Province China
Data no
277698
Author
Anhui Guangxin Agrochemical Co., Ltd.
Title
Synthesis and Impurities of Indoxacarb Technical
Study date
2023
Authorising party
Applicant
Auth party contact address
Pengcun village Xinhang Town Guangde County, Xuancheng City Anhui Province China
Data no
277697
Author
Anhui Guangxin Agrochemical Co., Ltd.
Title
Indoxacarb Chemistry and Manufacture
Study date
2024
Authorising party
Applicant
Auth party contact address
Pengcun village Xinhang Town Guangde County, Xuancheng City Anhui Province China
Data no
277701
Author
Anhui Guangxin Agrochemical Co., Ltd.
Title
Declaration of Composition (DoC) of Indoxacarb
Study date
2024
Authorising party
Applicant
Auth party contact address
Pengcun village Xinhang Town Guangde County, Xuancheng City Anhui Province China
Data no
277702
Author
Anhui Guangxin Agrochemical Co., Ltd.
Title
Indoxacarb Declaration of Manufacture and COAs
Study date
2024
Authorising party
Applicant
Auth party contact address
Pengcun village Xinhang Town Guangde County, Xuancheng City Anhui Province China
Data no
277703
Author
EFSA
Title
Indoxacarb EFSA Specification, 2018
Study date
2018
Authorising party
Public
Auth party contact address
-
Data no
277704
Author
Anhui Guangxin Agrochemical Co., Ltd.
Title
Indoxacarb SAFETY DATA SHEET
Study date
2024
Authorising party
Applicant
Auth party contact address
Pengcun village Xinhang Town Guangde County, Xuancheng City Anhui Province China
Date

Application Date

Application No

Application Number

145164
Product/Active constituent Name

Application Product Name

Kilblat

Application details

Product name:

Kilblat

Product number:

95274

Applicant Name:

CALLINGTON HAVEN PTY LTD

Application purpose and description of use:

Registration of Kilblat 250 (Aerosol) product containing 0.3 Cyphenothrin/ 0.1 d- tetramethrin product for CRAWLING INSECT (Cockroaches) for Indoor application.  

Reference details:

53419 - SUMIBLAST WATER-BASED AEROSOL 1.0/3.0 HOUSEHOLD INSECT RESIDUAL SPRAY

Active constituents:

Active constituent name
50874 - CYPHENOTHRIN
Active constituent name
50869 - TETRAMETHRIN [(1R)- ISOMERS]

Description of data provided:

Data no
293195
Author
Anon
Title
COAS of Active Ingredients
Study date
March 2023
Authorising party
Applicant
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
293197
Author
Anon
Title
5165_400_SNS Kilblat 400ml MPS Rev 8
Study date
06/05/2025
Authorising party
Applicant
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
293196
Author
Anon
Title
Declaration of the Composition Kilblat
Study date
8/10/2025
Authorising party
Applicant
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
277409
Author
Mr. Shyam Kale
Title
2024_Accelerated Stability Study Kilblat 50C 4 weeks
Study date
05/08/2024
Authorising party
Applicant
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
277410
Author
anon
Title
Kilblat 400g V7 130824
Study date
2024
Authorising party
Applicant
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Data no
293198
Author
Anon
Title
Raw material SDS for Kilblat
Study date
08/10/2025
Authorising party
Applicant
Auth party contact address
30 SOUTH ST RYDALMERE Australia
Date

Application Date

Application No

Application Number

145290
Product/Active constituent Name

Application Product Name

TRAMAT 500 SC SELECTIVE HERBICIDE

Application details

Product name:

TRAMAT 500 SC SELECTIVE HERBICIDE

Product number:

39508

Applicant Name:

BAYER CROPSCIENCE PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to extend the registration to all states.

Active constituents:

Active constituent name
44156 - ETHOFUMESATE
Date

Application Date

Application No

Application Number

145278
Product/Active constituent Name

Application Product Name

CONQUEST FASTER TG 200 HERBICIDE

Application details

Product name:

CONQUEST FASTER TG 200 HERBICIDE

Product number:

69725

Applicant Name:

CONQUEST CROP PROTECTION PTY LTD

Application purpose and description of use:

Variation of pack size and other particulars

Reference details:

39118 - BASTA NON-SELECTIVE HERBICIDE
62489 - BIFFO NON-SELECTIVE HERBICIDE
62489 - Nufarm Biffo Herbicide
68987 - FARMALINX COMMANDO 200 HERBICIDE

Active constituents:

Active constituent name
64779 - GLUFOSINATE-AMMONIUM

Description of data provided:

Data no
277623
Author
Kail Bastow
Title
01 - Application Overview
Study date
Aug 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Date

Application Date

Application No

Application Number

145063
Product/Active constituent Name

Application Product Name

INTRUDER INSECTICIDE

Application details

Product name:

INTRUDER INSECTICIDE

Product number:

58300

Applicant Name:

NIPPON SODA CO., LTD

Application purpose and description of use:

Variation of product registration and label approval to include control of silverleaf whitefly in cotton.

Reference details:

58558 - CROWN 225SL SYSTEMIC INSECTICIDE
67071 - PRIMAL INSECTICIDE
67783 - ECHEM ACETAM 225 INSECTICIDE
81486 - SKOPE INSECTICIDE
88016 - Genfarm Acetamiprid 225 Insecticide
89230 - Bingo SG Agricultural Insecticide
90435 - RELYON ACETAMIPRID 225 INSECTICIDE

Active constituents:

Active constituent name
54234 - ACETAMIPRID

Description of data provided:

Data no
276683
Author
Anon
Title
Part 8 Efficacy and Host Crop Safety
Study date
April 2024
Authorising party
Applicant
Data no
276684
Author
Westerhuis, D.
Title
ES1 Various Insecticides for Control of SLWF
Study date
28 Jan 2022
Authorising party
AgNova Technologies Pty Ltd
Auth party contact address
Unit 4, 482 Kingsford Smith Drive, Hamilton, Qld 4007
Data no
276685
Author
Horowitz, A.R., Medelson, Z., Weintraub, P.G. and Ishaaya, I
Title
ES2 Comparative toxicity of foliar and systemic applications of acetamiprid and imidacloprid against the cotton whitefly, Bemisia tabaci (Hemiptera: Aleyrodidae)
Study date
1998
Authorising party
Public
Auth party contact address
-
Data no
276686
Author
Macpherson, M
Title
ES3 Evaluation of Various Insecticides for use on Cotton
Study date
22 June 2022
Authorising party
Applicant
Date

Application Date

Application No

Application Number

145082
Product/Active constituent Name

Application Product Name

4FARMERS MetAzoxy Fungicide

Application details

Product name:

4FARMERS MetAzoxy Fungicide

Product number:

95249

Applicant Name:

4 FARMERS AUSTRALIA PTY LTD

Application purpose and description of use:

Registration of a 124g/L Metalaxyl-m + 322g/L SE Fungicide , for teh control of Rhizoctonia, Pythlum, Leaf Rust and Net Blotch in Barley, control of Rhizoctonia, Pythiium and Stribe Rust in Wheat, and suppression of Powdery Mildew in Barley and Yellow Spot in Wheat, as per DIRECTION FOR USE

Reference details:

69673 - UNIFORM FUNGICIDE

Active constituents:

Active constituent name
81437 - Metalaxyl-M
Active constituent name
66812 - AZOXYSTROBIN

Description of data provided:

Data no
277747
Author
Rod Jeffs/Peet Van Rensburg
Title
QCM-050-azoxystrobin and metalaxyl-M TGAC & formulated product by HPLC
Study date
09.08.24
Authorising party
Applicant
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
277748
Author
Rod Jeffs/Peet Van Rensburg
Title
Validation of method QCM for the assay of azoxystrobin and metalaxyl-M
Study date
09.08.24
Authorising party
Applicant
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
277745
Author
Rod Jeff/Peet Van Rensburg
Title
Part 2 Chemistry and Manufacture
Study date
09.08.24
Authorising party
Applicant
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
277746
Author
Rod Jeffs & Peet Van Rensburg
Title
stability data
Study date
09.08.24
Authorising party
Applicant
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
277751
Author
David Bell
Title
4 Farmers Barley fungicide metalaxyl-M & azoxystrobin trial report
Study date
2020
Authorising party
Applicant
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
277752
Author
David Bell
Title
4 Farmers Wheat fungicide metalaxyl-M & azoxystrobin trial report
Study date
2020
Authorising party
Applicant
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
277753
Author
Michael Lamond
Title
Metalaxyl-M for the control of rhizoctonia in spring barley
Study date
2018
Authorising party
Applicant
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
277754
Author
Michael Lamond
Title
metalaxyl-M for the control of Rhizoctonia in spring barley
Study date
2018
Authorising party
Applicant
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
277750
Author
Zhejiang Heben Group
Title
Certificate of Analysis
Study date
2024
Authorising party
Applicant
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
277749
Author
ANON
Title
Safety Data Sheets (SDS) for components
Study date
2024
Authorising party
Applicant
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Date

Application Date

Application No

Application Number

145277
Product/Active constituent Name

Application Product Name

SNAILEX SLUG AND SNAIL PELLETS

Application details

Product name:

SNAILEX SLUG AND SNAIL PELLETS

Product number:

68580

Applicant Name:

AGRIBAIT PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to increase the application rate in certain situations.

Reference details:

33252 - DAVID GRAYS SNAIL KILLER PELLETS
49586 - ALGI-KILL 250
64990 - IMTRADE METAKILL SNAIL & SLUG BAIT

Active constituents:

Active constituent name
58212 - METALDEHYDE

Description of data provided:

Data no
277646
Author
H Brodie, G Baker, L Salehi, M Nash, K Perry, N Cunningham
Title
Chapter 5: Caged field trials testing bait rates and snail densities
Study date
18/12/2017
Authorising party
Public
Auth party contact address
-
Data no
277648
Author
M Habner
Title
Snail & Slug Bait Comparison
Study date
13/05/2024
Authorising party
Applicant
Auth party contact address
Lot 33/46 Pine Freezers Road Port Lincoln Australia
Data no
277649
Author
Imtrade Pty Ltd
Title
Imtrade Metakill Snail & Slug Bait 64990/117488
Study date
21/01/2019
Authorising party
Public
Auth party contact address
-
Data no
277650
Author
David Gray & Co Pty Ltd
Title
David Grays Snail Killer Pellets
Study date
June 2006
Authorising party
Public
Auth party contact address
-
Data no
277651
Author
F Johnston
Title
Part 8 Summary
Study date
August 2024
Authorising party
Applicant
Auth party contact address
Lot 33/46 Pine Freezers Road Port Lincoln Australia
Data no
277647
Author
M Nash
Title
Successful crop protection from slugs
Study date
August 2022
Authorising party
Public
Auth party contact address
-
Data no
277644
Author
M Nash, H DeGraaf, G Baker
Title
Snail and slug baiting guidelines:
Study date
November 2016
Authorising party
Public
Auth party contact address
-
Data no
277645
Author
K Perry and L Nelson
Title
Nail the snails: A practical guide to integrated snail control for Australian grain growers.
Study date
May 2023
Authorising party
Public
Auth party contact address
-
Date

Application Date

Application No

Application Number

144993
Product/Active constituent Name

Application Product Name

DERMCARE OTOFLUSH

Application details

Product name:

DERMCARE OTOFLUSH

Product number:

60080

Applicant Name:

DERMCARE-VET PTY. LTD.

Application purpose and description of use:

Variation of product registration and label approval to make a change to the product formulation.

Active constituents:

Active constituent name
86007 - DISODIUM EDETATE

Description of data provided:

Data no
276318
Author
Dermcare-Vet
Title
PHMB API
Study date
November 2021
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
276319
Author
Dermcare-Vet
Title
EDTA API
Study date
March 2020
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
285742
Author
Dermcare-Vet Pty Ltd
Title
s159 (1)(a)_response_otoflush_01052025
Study date
2025
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
285743
Author
Dermcare-Vet Pty Ltd
Title
Appendix 3.0_Otoflush 0.1% Trending
Study date
2025
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
285744
Author
Dermcare-Vet Pty Ltd
Title
Appendix 4.0_CoA D0240A Otoflush 0.1%
Study date
2025
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
285745
Author
Dermcare-Vet Pty Ltd
Title
Appendix 1.0_FPS-051.03 Otoflush 0.1%_draft
Study date
2025
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
285746
Author
Dermcare-Vet Pty Ltd
Title
Appendix 2.0_ES-034.03 Otoflush 0.1%_draft
Study date
2025
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
276320
Author
Dermcare-Vet
Title
Excipients
Study date
November 2020
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
276321
Author
Dermcare-Vet
Title
Otoflush_manufacturing process
Study date
April 2016
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
276322
Author
Dermcare-Vet
Title
Manufacturing process
Study date
April 2024
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
276323
Author
Dermcare-Vet
Title
CoA
Study date
2022
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
276325
Author
Dermcare-Vet
Title
Analytical method validation_PHMB
Study date
2022
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
276326
Author
Dermcare-Vet
Title
Analytical method validation_PHMB
Study date
2022
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
276327
Author
Dermcare-Vet
Title
Analytical method validation_EDTA
Study date
2022
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
276328
Author
Dermcare-Vet
Title
Analytical method validation_EDTA
Study date
2022
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
276329
Author
Dermcare-Vet
Title
Analytical method validation_EDTA
Study date
2022
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
276330
Author
Dermcare-Vet
Title
microbial method validation_PET
Study date
2023
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
276331
Author
Dermcare-Vet
Title
Packaging specification
Study date
2022
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
276316
Author
Dermcare-Vet
Title
Chemistry and Manufacture
Study date
2024
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
276324
Author
Dermcare-Vet
Title
Interim 18m stability report_May2024
Study date
May 2024
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
280645
Author
Dermcare-vet
Title
Otoflush_additional information_15112024
Study date
2024
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
282527
Author
May ER, Ratliff BE, Bemis DA
Title
Antibacterial effect of N-acetylcysteine in combination with antimicrobials on common canine otitis externa bacterial isolates. Vet Dermatol. 2019 Dec;30(6):531-e161. doi: 10.1111/vde.12795. Epub 2019 Oct 31. PMID: 31670428.
Study date
2019
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
282528
Author
Luciani L, Stefanetti V, Rampacci E, Gobbi P, Valentini L, Capuozzo R, Passamonti F
Title
Comparison between clinical evaluations and laboratory findings and the impact of biofilm on antimicrobial susceptibility in vitro in canine otitis externa. Vet Dermatol. 2023 Dec;34(6):586-596. doi: 10.1111/vde.13197. Epub 2023 Aug 14. PMID: 37580811.
Study date
2023
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
282529
Author
Vercelli C, Pasquetti M, Giovannetti G, Visioni S, Re G, Giorgi M, Gambino G, Peano A
Title
In vitro and in vivo evaluation of a new phytotherapic blend to treat acute externa otitis in dogs. J Vet Pharmacol Ther. 2021 Nov;44(6):910-918. doi: 10.1111/jvp.13000. Epub 2021 Jul 13. PMID: 34258792; PMCID: PMC9290716.
Study date
2021
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
282530
Author
Saengchoowong S, Jitvaropas R, Poomipak W, Praianantathavorn K, Payungporn S
Title
Identification of bacteria associated with canine otitis externa based on 16S rDNA high-throughput sequencing. Braz J
Study date
2023
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
282531
Author
Nuttall T.
Title
Managing recurrent otitis externa in dogs: what have we learned and what can we do better? J Am Vet Med Assoc. 2023 Apr 7;261(S1):S10-S22. doi: 10.2460/javma.23.01.0002. PMID: 37019436
Study date
2023
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
282532
Author
N/A
Title
Microbiology of the Ear of the Dog and Cat | Veterian Key
Study date
2016
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
282533
Author
N/A
Title
Otitis Externa?Refractory and Recurrent Cases - WSAVA 2018 Congress - VIN
Study date
2018
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
282534
Author
Merja R
Title
DCV1.2018. Study report on A randomised, double -blinded efficacy study of Dermcare-Vet Otoflush in comparison of Tris-EDTA as an ear cleaner in canine chronic otitis.
Study date
2020
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
282535
Author
Drusano GL, Liu W, Kulawy R, Louie A.
Title
Impact of granulocytes on the antimicrobial effect of tedizolid in a mouse thigh infection model. Antimicrobial Agents and Chemotherapy. 2011; 55:5300-5.
Study date
2011
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
282536
Author
Drusano GL, Vanscoy B, Liu W, Fikes S, Brown D, Louie A
Title
Saturability of granulocyte kill of Pseudomonas aeruginosa in a murine model of pneumonia. Antimicrobial Agents and Chemotherapy. 2011; 55:2693-5.
Study date
2011
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
282537
Author
Drusano GL, Liu W, Fikes S, Cirz R, Robbins N, Kurhanewicz S
Title
Interaction of drug-and granulocyte-mediated killing of Pseudomonas aeruginosa in a murine pneumonia model. The Journal of Infectious Diseases. 2014; 210:1319-24.
Study date
2014
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
282538
Author
Mason, K.V., Wigg, J. Kenyon, F. and Doecke, J.
Title
The correlation of in vivo versus in vitro antibiotic susceptibility and kill rates after treatment with Otoflush? of Pseudomonas aeruginosa a pathogen found in chronic cases of Otitis Externa in the dog. Dermcare-Vet Pty Ltd. Trial DCV 2.2006.
Study date
2006
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
282539
Author
Shaw, S
Title
Pathogens in otitis externa: diagnostic techniques to identify secondary causes of ear disease. In Practice, 38: 12- 16. https://doi.org/10.1136/inp.i461
Study date
2016
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
282540
Author
Islam K, Sime FB, Wallis SC, Bauer MJ, Naicker S, Won H, Zowawi HM
Title
Pharmacodynamics of Piperacillin-Tazobactam/Amikacin Combination versus Meropenem against Extended-Spectrumb-Lactamase-Producing Escherichia coli in a Hollow Fiber Infection Model
Study date
2022
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
282541
Author
Foerster S, Unemo M, Hathaway LJ, Low N, Althaus CL
Title
Time-kill curve analysis and pharmacodynamic modelling for in vitro evaluation of antimicrobials against Neisseria gonorrhoeae. BMC Microbiol. 2016 Sep 17;16:216. doi: 10.1186/s12866-016-0838-9. PMID: 27639378; PMCID: PMC5027106.
Study date
2016
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
282542
Author
Akers KS, Cardile AP, Wenke JC, Murray CK
Title
Biofilm formation by clinical isolates and its relevance to clinical infections. Adv Exp Med Biol. 2015;830:1-28. doi: 10.1007/978-3-319-11038-7_1. PMID: 25366218.
Study date
2015
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
282543
Author
Kenneth.V.M
Title
The synergistic effect of PHMB and EDTA in Otoflush ? increasing the antibiotic susceptibility and kill rates after treatment with Otoflush of P.aeruginosa a pathogen found in chronic cases of Otitis externa in the dog.
Study date
2006
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
282544
Author
Dermcare-Vet
Title
Otoflush_summary table_02122024
Study date
2024
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
276317
Author
Dermcare-Vet
Title
In vitro efficacy of different Otoflush formulations_A dose-response of polihexanide
Study date
2024
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Data no
282526
Author
O?Neill, D.G., Volk, A.V., Soares, T. et al
Title
Frequency and predisposing factors for canine otitis externa in the UK ? a primary veterinary care epidemiological view. Canine Genet Epidemiol 8, 7 (2021). https://doi.org/10.1186/s40575-021-00106-1
Study date
2021
Authorising party
Applicant
Auth party contact address
7 Centenary Road SLACKS CREEK Australia
Date

Application Date

Application No

Application Number

144880
Product/Active constituent Name

Application Product Name

HYVAR X HERBICIDE WETTABLE GRANULE

Application details

Product name:

HYVAR X HERBICIDE WETTABLE GRANULE

Product number:

95183

Applicant Name:

AGNOVA TECHNOLOGIES PTY LTD

Application purpose and description of use:

Registration of a 800 g/kg bromacil wettable granule product for the control of certain annual broadleaved weeds and grasses in citrus, pineapple, asparagus and in commercial and industrial areas, rights of way and around agricultural buildings.

Reference details:

62760 - URAGAN WG HERBICIDE
85153 - 4Farmers Bromacil 800 WG Herbicide
87247 - IMTRADE BROMACIL 800 WG HERBICIDE
94196 - Farmalinx BroMax 800 WG Herbicide
31348 - HYVAR X HERBICIDE WETTABLE POWDER

Active constituents:

Active constituent name
62289 - BROMACIL
Active constituent name
44452 - BROMACIL

Description of data provided:

Data no
275783
Author
Anon
Title
C1 Manufacturing Process of Bromacil 80% WG, Yifan Biotechnology Group Co., Ltd.
Study date
2022
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
275786
Author
Anon
Title
Doc J Hyvar X Herbicide WG Document J Confidential Information.
Study date
July 2024
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
275782
Author
Anon
Title
Part 2 Chemistry and Manufacture
Study date
July 2024
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
275784
Author
Susie Wang, M.Y.
Title
C2 Physico-chemical Properties of Bromacil 80% WG
Study date
9 August 2021
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
275785
Author
Anon
Title
C3 Physical and Chemical Report of Bromacil 80% WG
Study date
April 2022
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
286651
Author
Zikic, O.
Title
C4 FR1068 Hyvar 800WG Stability Test
Study date
31 July 2023
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
275787
Author
Anon
Title
Part 8 Efficacy and Crop Safety
Study date
July 2024
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
275788
Author
David Kohler
Title
ES1 AV20109-1 Herbicide comparison trial on roadsides
Study date
24 May 2021
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
275789
Author
Mitchell Faint
Title
ES2 AV20109-2 Herbicide comparison trial in citrus
Study date
24 May 2021
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Data no
286652
Author
Anon
Title
C5 Response to S-159 Hyvar X
Study date
May 2025
Authorising party
Applicant
Auth party contact address
Unit 4, 482 Kingsford Smith Drive HAMILTON Australia
Date

Application Date

Application No

Application Number

145175
Product/Active constituent Name

Application Product Name

Skin2P Body No Perfume

Application details

Product name:

Skin2P Body No Perfume

Product number:

93558

Applicant Name:

CALLINGTON HAVEN PTY LTD

Application purpose and description of use:

Variation of product label to amend claims and correct active constituent on label

Reference details:

65744 - OFF! TROPICAL STRENGTH INSECT REPELLENT SPRAY

Active constituents:

Active constituent name
44493 - PICARIDIN
Date

Application Date

Application No

Application Number

145017
Product/Active constituent Name

Application Product Name

Pyrantel Embonate

Application details

Product name:

Pyrantel Embonate

Active name:

Pyrantel Embonate

Applicant Name:

JIANGSU JIYU BIO-PHARMACEUTICAL TECHNOLOGY CO., LTD.

Application purpose and description of use:

Approval of Pyrantel Embonate for use in veterinary chemical products.

Description of data provided:

Data no
276463
Author
European Pharmacopoeia
Title
Pyrantel embonate European Pharmacopoeia standard
Study date
January 2024
Authorising party
Public
Auth party contact address
-
Data no
276464
Author
US Pharmacopoeia
Title
Pyrantel Pamoate US Pharmacopoeia standard
Study date
2024
Authorising party
Public
Auth party contact address
-
Data no
276465
Author
Not identified
Title
Pyrantel Embonate COAs EP
Study date
2023
Authorising party
Applicant
Auth party contact address
No. 20, Yuhe Road, Pukou District NANJING China
Data no
276466
Author
Not identified
Title
Pyrantel Pamoate COAs USP
Study date
2023
Authorising party
Applicant
Auth party contact address
No. 20, Yuhe Road, Pukou District NANJING China
Date

Application Date

Application No

Application Number

145062
Product/Active constituent Name

Application Product Name

Eco Tec Solutions Insect Killer with Natural Pyrethrins

Application details

Product name:

Eco Tec Solutions Insect Killer with Natural Pyrethrins

Product number:

95241

Applicant Name:

ECO TEC SOLUTIONS PTY LTD

Application purpose and description of use:

Registration of a 9g/kg PYRETHRINS, 42.3 g/kg PIPERONYL BUTOXIDE, aerosol product for the control of most flying insects by releasing a controlled amount of natural pyrethrins at regular programmed intervals.

Reference details:

67789 - PY-ZAPP NATURAL PYRETHRUM METERED INSECTICIDE

Active constituents:

Active constituent name
45532 - PIPERONYL BUTOXIDE
Date

Application Date

Application No

Application Number

144634
Product/Active constituent Name

Application Product Name

eFume Active

Application details

Product name:

eFume Active

Product number:

94020

Applicant Name:

DRASLOVKA SERVICES PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to vary the range of the pack size, vary the DFU, add new manufacturing site and to add new situations/pests based on the reference product.

Reference details:

88523 - eFUME FUMIGANT

Description of data provided:

Data no
274077
Author
Anon
Title
Excutive Summary and Scientific Arguments
Study date
15/06/2024
Authorising party
Applicant
Auth party contact address
15-17 Second Avenue Sunshine Australia
Date

Application Date

Application No

Application Number

145230
Product/Active constituent Name

Application Product Name

YP Amoxycillin Soluble Powder

Application details

Product name:

YP Amoxycillin Soluble Powder

Product number:

88291

Applicant Name:

SOUTH YARRA PHARMA PTY LTD

Application purpose and description of use:

Variation of product registration and label approval to vary product particulars.

Active constituents:

Active constituent name
87889 - Amoxicillin trihydrate