APVMA Gazette No. 23, 19 November 2013Nov 19, 2013  · Product Name: Timtech Azguard HF LOSP Wood...

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No. APVMA 23, Tuesday, 19 November 2013 Published by The Australian Pesticides & Veterinary Medicines Authority AGRICULTURAL AND VETERINARY CHEMICALS The Agricultural and Veterinary Chemical Code Act 1994 (the Act) commenced on 15 March 1995. The Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Act requires notices to be published in the Gazette containing details of the registration of agricultural and veterinary chemical products and other approvals granted by the Australian Pesticides and Veterinary Medicines Authority. The Agvet Code and related legislation also requires certain other notices to be published in the Gazette. A reference to Agvet Codes in this publication is a reference to the Agvet Code in each state and territory jurisdiction. ISSN 1837 7629

Transcript of APVMA Gazette No. 23, 19 November 2013Nov 19, 2013  · Product Name: Timtech Azguard HF LOSP Wood...

Page 1: APVMA Gazette No. 23, 19 November 2013Nov 19, 2013  · Product Name: Timtech Azguard HF LOSP Wood Preservative Concentrate Active Constituent/s: 16 g/L permethrin, 22.5 g/L propiconazole,

No. APVMA 23, Tuesday, 19 November 2013

Published by The Australian Pesticides & Veterinary Medicines Authority

AGRICULTURAL AND

VETERINARY CHEMICALS

The Agricultural and Veterinary Chemical Code Act 1994 (the Act) commenced on 15 March 1995.

The Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Act requires notices to be

published in the Gazette containing details of the registration of agricultural and veterinary chemical products

and other approvals granted by the Australian Pesticides and Veterinary Medicines Authority. The Agvet Code

and related legislation also requires certain other notices to be published in the Gazette. A reference to Agvet

Codes in this publication is a reference to the Agvet Code in each state and territory jurisdiction.

ISSN 1837 – 7629

Page 2: APVMA Gazette No. 23, 19 November 2013Nov 19, 2013  · Product Name: Timtech Azguard HF LOSP Wood Preservative Concentrate Active Constituent/s: 16 g/L permethrin, 22.5 g/L propiconazole,

Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 2

Commonwealth of Australia 2013

This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any

process without prior written permission from the Australian Pesticides and Veterinary Medicines Authority. Requests and

inquiries concerning reproduction and rights should be addressed to:

The Manager, Public Affairs and Communications

The Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

Kingston ACT 2604

Email: [email protected]

Website: www.apvma.gov.au.

GENERAL INFORMATION

The APVMA (Australian Pesticides and Veterinary Medicines Authority) Gazette is published fortnightly and contains details of

the registration of agricultural and veterinary chemicals products and other approvals granted by the APVMA, notices as requi red

by the Agricultural and Veterinary Chemicals Code (the Agvet Code) and related legislation and a range of regulatory material

issued by the APVMA.

Pursuant to section 53(1) of the Agvet Code, the APVMA has decided that it is unnecessary to publish details of applications

made for the purpose of notifying minor variations to registration details. The APVMA will however report notifications activity in

quarterly statistical reports.

DISTRIBUTION AND SUBSCRIPTION

The APVMA Gazette is published in electronic format only and is available from the APVMA website,

www.apvma.gov.au/publications/gazette/.

If you would like to receive email notification when a new edition is published, please subscribe on the APVMA website.

APVMA CONTACTS

For enquiries regarding the publishing and distribution of the APVMA Gazette: Telephone: +61 2 6210 4870

For enquiries on the APVMA Gazette content, please refer to the individual APVMA contacts listed under each notice.

Page 3: APVMA Gazette No. 23, 19 November 2013Nov 19, 2013  · Product Name: Timtech Azguard HF LOSP Wood Preservative Concentrate Active Constituent/s: 16 g/L permethrin, 22.5 g/L propiconazole,

Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 3

CONTENTS

Notice of Registrations 4 Agricultural Chemical Products .............................................................................................................................................. 4 Veterinary Chemical Products .............................................................................................................................................. 12

Other Notices 15 Licensing of Veterinary Chemical Manufacturers ................................................................................................................. 15 Addendum to the Record of Approved Active Constituents .................................................................................................. 20

Page 4: APVMA Gazette No. 23, 19 November 2013Nov 19, 2013  · Product Name: Timtech Azguard HF LOSP Wood Preservative Concentrate Active Constituent/s: 16 g/L permethrin, 22.5 g/L propiconazole,

Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 4

Notice of Registrations – Agricultural Chemical Products

NOTICE OF REGISTRATIONS

Agricultural Chemical Products

Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals

Code Act 1994, the APVMA hereby gives notice that it has registered or varied the registration in respect of the following

products, with effect from the dates shown.

1. RESTRICTED PRODUCT

Product Name: Termigreen Termite Barrier

Active Constituent/s: 5.2 g/kg bifenthrin

Applicant Name: The White Ant Co. Pty. Ltd.

Applicant ACN: 100 706 009

Summary of Use: For use as a termite-resistant physical barrier in buildings for the protection of structures from concealed termite entry

Date of Registration: 4 November 2013

Label Approval No: 69236/60324

Product Name: 4Farmers 1080 Impregnated Oats (Fox Control)

Active Constituent/s: 3 mg sodium fluoroacetate (1080) per oat

Applicant Name: 4Farmers Australia Pty Ltd

Applicant ACN: 160 092 428

Summary of Use: For the control of foxes

Date of Registration: 6 November 2013

Label Approval No: 68726/58962

2. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Product Name: Ecomist Enhancing Your Environment Insect Sniper Residual Surface Spray

Active Constituent/s: 2 g/kg cyphenothrin, 2 g/kg d-tetramethrin

Applicant Name: Damar Industries Pty Limited

Applicant ACN: 097 723 610

Summary of Use: For knockdown and residual control of household insects such as ants, carpet beetles, cockroaches, fleas, flies, millipedes, mosquitoes, adult moth & moth larvae, silverfish, slaters, spiders & wasps. Effective control of cockroaches & other crawling insects for up to 3 months

Date of Registration: 15 October 2013

Label Approval No: 69306/60449

Product Name: Vantal Upgrade Insecticide/Miticide

Active Constituent/s: 36 g/L abamectin

Applicant Name: Ospray Pty Ltd

Applicant ACN: 110 199 169

Summary of Use: For the control of certain mite and insect pests in various fruit and vegetable crops, cotton, hops and ornamentals

Date of Registration: 23 October 2013

Label Approval No: 67524/56279

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Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 5

Notice of Registrations – Agricultural Chemical Products

Product Name: Ilium Cephalexin 600 For Dogs

Active Constituent/s: Each tablet contains 600 mg cephalexin (as cephalexin monohydrate)

Applicant Name: Troy Laboratories Pty Ltd

Applicant ACN: 000 283 769

Summary of Use: For the treatment of bacterial infections of the skin, soft tissue, joint respiratory tract and urinary tract of dogs

Date of Registration: 25 October 2013

Label Approval No: 67796/56888

Product Name: Brumby 480 SC Fungicide

Active Constituent/s: 480 g/L prothioconazole

Applicant Name: Bayer CropScience Pty Ltd

Applicant ACN: 000 226 022

Summary of Use: For control of leaf diseases in peanuts

Date of Registration: 30 October 2013

Label Approval No: 68332/58132

Product Name: Tops Plant Growth Regulator

Active Constituent/s: 100 g/kg triclopyr

Applicant Name: Agriphar S.A.

Applicant ACN: N/A

Summary of Use: For thinning and increasing fruit size in oranges and mandarins and for reducing fruit drop in lychees

Date of Registration: 5 November 2013

Label Approval No: 66481/53736

Product Name: Kenso Agcare Gundy 240 Herbicide

Active Constituent/s: 240 g/L imazapic present as the ammonium salt

Applicant Name: Kenso Corporation (M) Sdn. Bhd.

Applicant ACN: N/A

Summary of Use: For the pre-emergence control of certain annual grass and broadleaf weeds in fallow

situations and sugarcane

Date of Registration: 5 November 2013

Label Approval No: 67108/55225

Product Name: Sinochem Intersect 200SC Insecticide

Active Constituent/s: 200 g/L imidacloprid

Applicant Name: Sinochem Agro Co., Ltd

Applicant ACN: N/A

Summary of Use: For the control of various insect pests of cotton, fruit, vegetables and ornamentals

Date of Registration: 6 November 2013

Label Approval No: 68892/59319

Product Name: Nufarm Weedmaster Argo Dual Salt Technology Herbicide

Active Constituent/s: 540 g/L glyphosate (present as the potassium and isopropylamine salts)

Applicant Name: Nufarm Australia Limited

Applicant ACN: 004 377 780

Summary of Use: For use as a non-selective herbicide for the control of various annual and perennial weeds

Date of Registration: 7 November 2013

Label Approval No: 68925/59392

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Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 6

Notice of Registrations – Agricultural Chemical Products

Product Name: Farmalinx Bazooka 800 SG Herbicide

Active Constituent/s: 800 g/kg glyphosate (present as the acid and ammonium salt)

Applicant Name: Farmalinx Pty Ltd

Applicant ACN: 134 353 245

Summary of Use: For control of annual and perennial weeds in a range of agricultural and non-agricultural situations

Date of Registration: 8 November 2013

Label Approval No: 69121/60015

Product Name: TimTech Azguard LOSP Wood Preservative Concentrate

Active Constituent/s: 16 g/L permethrin, 22.5 g/L propiconazole, 22.5 g/L tebuconazole

Applicant Name: TimTech Chemicals Pty Ltd

Applicant ACN: 096 245 108

Summary of Use: For the protection of softwood timber to be used for hazard level 3 situations (outside and above ground) against fungal decay and timber insects, such as borers and termites

Date of Registration: 8 November 2013

Label Approval No: 66270/58806

Product Name: Bard High Performance Surface Spray

Active Constituent/s: 0.7 g/kg imiprothrin, 2 g/kg cypermethrin

Applicant Name: Barr Glebe Group Pty Ltd

Applicant ACN: 119 998 435

Summary of Use: For use in domestic situations for control of crawling insects

Date of Registration: 8 November 2013

Label Approval No: 69482/60913

Product Name: Searles Trifend Complete Garden Spray

Active Constituent/s: 0.1 g/L tau-fluvalinate, 0.05 g/L myclobutanil

Applicant Name: J C & A T Searle Pty Ltd

Applicant ACN: 002 898 893

Summary of Use: For control of insects on plants in the home garden

Date of Registration: 8 November 2013

Label Approval No: 69363/60593

Product Name: Advion Fire Ant Bait

Active Constituent/s: 0.45 g/kg indoxacarb

Applicant Name: Du Pont (Australia) Pty Ltd

Applicant ACN: 000 716 469

Summary of Use: For the control of fire ants in a range of urban and agricultural situations

Date of Registration: 8 November 2013

Label Approval No: 66532/53830

Product Name: Apparent Propiconazole 250 EC Fungicide

Active Constituent/s: 250 g/L propiconazole

Applicant Name: Apparent Pty. Ltd.

Applicant ACN: 143 724 136

Summary of Use: For the control of certain fungal diseases of bananas, oats, peanuts, perennial ryegrass, pineapples, stone fruit, sugarcane, wheat and other crops

Date of Registration: 11 November 2013

Label Approval No: 69469/60895

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Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 7

Notice of Registrations – Agricultural Chemical Products

Product Name: Apparent Dicamba 700 Herbicide

Active Constituent/s: 700 g/kg dicamba present as the sodium salt

Applicant Name: Apparent Pty. Ltd.

Applicant ACN: 143 724 136

Summary of Use: For the control of certain broadleaf weeds in winter cereals, pastures, conservation tillage, sugarcane, rice, turf, grain sorghum and non-crop areas

Date of Registration: 11 November 2013

Label Approval No: 69471/60899

Product Name: Timtech Azguard HF LOSP Wood Preservative Concentrate

Active Constituent/s: 16 g/L permethrin, 22.5 g/L propiconazole, 22.5 g/L tebuconazole

Applicant Name: TimTech Chemicals Pty Ltd

Applicant ACN: 096 245 108

Summary of Use: For the protection of softwood timber to be used for hazard level H3 (outside and above ground) situations against fungal decay and timber insects, including lyctids, borers and termites

Date of Registration: 11 November 2013

Label Approval No: 68590/58650

Product Name: FMC Imazapic 240 Herbicide

Active Constituent/s: 240 g/L imazapic present as the ammonium salt

Applicant Name: FMC Australasia Pty Ltd

Applicant ACN: 095 326 891

Summary of Use: For the pre-emergence control of certain annual grass and broadleaf weeds in fallow situations, sugarcane and peanuts and early post-emergence control of certain annual grass and broadleaf weeds in peanuts and sugarcane

Date of Registration: 11 November 2013

Label Approval No: 69495/60935

Product Name: Fascinate 200 SL Herbicide

Active Constituent/s: 200 g/L glufosinate-ammonium

Applicant Name: United Phosphorus Ltd.

Applicant ACN: 066 391 384

Summary of Use: For use in various situations for non-residual control of broadleaf and grass weeds

Date of Registration: 11 November 2013

Label Approval No: 69545/61093

Product Name: AC Epoch 125 SC Fungicide

Active Constituent/s: 125 g/L epoxiconazole

Applicant Name: Axichem Pty Ltd

Applicant ACN: 131 628 594

Summary of Use: For the control of leaf rust, stripe rust and septoria nodorum blotch in wheat and leaf rust in barley

Date of Registration: 11 November 2013

Label Approval No: 69445/60811

Product Name: Enviromax Bromoxynil-MCPA Selective Herbicide

Active Constituent/s: 200 g/L bromoxynil as the octanoate, 200 g/L MCPA as the ethyl hexyl ester

Applicant Name: Enviromax Technologies Pty Ltd

Applicant ACN: 132 643 577

Summary of Use: For use in the control of weeds in wheat, oats, barley, cereal rye, triticale, l inseed, grass pastures and turf

Date of Registration: 12 November 2013

Label Approval No: 69397/60674

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Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 8

Notice of Registrations – Agricultural Chemical Products

Product Name: Kenso Agcare Bifenthrin Termiticide & Insecticide

Active Constituent/s: 100 g/L bifenthrin

Applicant Name: Kenso Corporation (M) Sdn Bhd

Applicant ACN: N/A

Summary of Use: For the protection of structures from subterranean termite damage, control of termites, other urban pests and various insect and mite pests in a variety of crops, including turf

Date of Registration: 12 November 2013

Label Approval No: 69277/60398

Product Name: Resource Gardening Rose Spray Insect Killer Ready To Use

Active Constituent/s: 0.1 g/L tau-fluvalinate, 0.05 g/L myclobutanil

Applicant Name: Amgrow Pty Ltd

Applicant ACN: 100 684 786

Summary of Use: For the control of various insects and fungal diseases on roses and ornamentals

Date of Registration: 12 November 2013

Label Approval No: 69376/60633

Product Name: Kenso Agcare Methomyl 225 Insecticide

Active Constituent/s: 225 g/L methomyl (an anti-cholinesterase compound)

Applicant Name: Kenso Corporation (M) Sdn. Bhd.

Applicant ACN: N/A

Summary of Use: For the control of insect pests in various crops

Date of Registration: 12 November 2013

Label Approval No: 69507/60956

Product Name: Agro-Gold Bifenthrin 2 Granule Insecticide

Active Constituent/s: 2 g/kg bifenthrin

Applicant Name: Agro-Alliance (Australia) Pty Ltd

Applicant ACN: 130 864 603

Summary of Use: For the control of certain pests in turf and ants, fleas and ticks in external surrounds of buildings and structures

Date of Registration: 13 November 2013

Label Approval No: 69435/60791

Product Name: Santalum Mosquito Repellent Incense Coils

Active Constituent/s: 15 g/kg citronella oil, 15 g/kg eucalyptus oil

Applicant Name: Mayo Hardware Pty Ltd

Applicant ACN: 071 517 176

Summary of Use: For repelling mosquitoes in outdoor domestic situations

Date of Registration: 13 November 2013

Label Approval No: 69451/60819

Product Name: Bard Fly And Insect Spray

Active Constituent/s: 6.36 g/kg N-octyl bicycloheptene dicarboximide, 4.34 g/kg piperonyl butoxide, 0.50 g/kg phenothrin 20:80, 2.16 g/kg tetramethrin 20:80

Applicant Name: Barr Glebe Group Pty Ltd

Applicant ACN: 119 998 435

Summary of Use: For household protection against flying insects

Date of Registration: 13 November 2013

Label Approval No: 69481/60912

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Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 9

Notice of Registrations – Agricultural Chemical Products

Product Name: IcON Phite 400 Systemic Fungicide

Active Constituent/s: 400 g/L phosphorous (phosphonic) acid present as mono (and) di potassium phosphite

Applicant Name: Sonic Essentials Pty Ltd

Applicant ACN: 127 016 406

Summary of Use: For the control of root rot in avocado and subterranean clover, root and collar rot in citrus, root and crown rot in ornamentals & root and heart rot in pineapples caused by phytophthora fungi and for the control of downy mildew in grapes

Date of Registration: 13 November 2013

Label Approval No: 69516/60992

Product Name: Amgrow Organosilicone Surfactant

Active Constituent/s: 1020 g/L polyether modified polysiloxane

Applicant Name: Amgrow Pty Ltd

Applicant ACN: 100 684 786

Summary of Use: For improved coverage, penetration and uptake of herbicides, fungicides, insecticides, miticides and foliar micro-nutrients

Date of Registration: 13 November 2013

Label Approval No: 69429/60773

Product Name: Agro-Gold Permethrin Insecticidal Dust

Active Constituent/s: 10 g/kg permethrin 25:75

Applicant Name: Agro-Alliance (Australia) Pty Ltd

Applicant ACN: 130 864 603

Summary of Use: For use as a ready to use dust treatment for the control of cockroaches, ants, fleas, silverfish, bedbugs, mushroom flies, potato moths, hide beetles and European Wasps

Date of Registration: 13 November 2013

Label Approval No: 69436/60792

Product Name: Apparent Imidacloprid 350 SC Insecticide

Active Constituent/s: 350 g/L imidacloprid

Applicant Name: Apparent Pty. Ltd.

Applicant ACN: 143 724 136

Summary of Use: For the control of Greyback and Childers canegrub in sugarcane and Silverleaf whitefly i n various vegetable crops

Date of Registration: 13 November 2013

Label Approval No: 69499/60944

Product Name: Sabakem Diclofop 375EC Selective Herbicide

Active Constituent/s: 375 g/L diclofop-methyl

Applicant Name: Sabakem Pty Ltd

Applicant ACN: 151 682 138

Summary of Use: For the post-emergent control of annual ryegrass, common barbgrass and wild oats in wheat, linseed, peas, turf and other crops

Date of Registration: 13 November 2013

Label Approval No: 69246/60336

Product Name: Avon Skin-So-Soft SSS Bug Guard Plus Picaridin Insect Repellent Aerosol With Vitamin E

Active Constituent/s: 97 g/kg picaridin

Applicant Name: Avon Products Pty Limited

Applicant ACN: 008 428 457

Summary of Use: For use as a personal insect repellent

Date of Registration: 13 November 2013

Label Approval No: 68813/59141

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Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 10

Notice of Registrations – Agricultural Chemical Products

Product Name: AC Caprice 570 EC Selective Herbicide

Active Constituent/s: 570 g/L MCPA present as the 2-ethyl hexyl ester

Applicant Name: Axichem Pty Ltd

Applicant ACN: 131 628 594

Summary of Use: For use in various agricultural crops

Date of Registration: 13 November 2013

Label Approval No: 69443/60809

Product Name: No Bugs Concentrate Insecticide

Active Constituent/s: 10 g/L deltamethrin

Applicant Name: Aussiecare Corporation Pty Limited

Applicant ACN: 051 456 038

Summary of Use: For the control of mosquitoes, houseflies and a range of other pest insects and mites in domestic, commercial, industrial and public buildings

Date of Registration: 14 November 2013

Label Approval No: 63358/45432

3. VARIATIONS

Product Name: Turf Culture Embargo Herbicide

Applicant Name: Turf Culture Pty Ltd

Applicant ACN: 117 986 615

Summary of Variation: To extend the use to include Queensland Blue Couch and for the suppression of Parramatta Grass and update the label

Date of Variation: 5 November 2013

Label Approval No: 65075/59274

Product Name: Transform Insecticide

Applicant Name: Dow AgroSciences Australia Limited

Applicant ACN: 003 771 659

Summary of Variation: To update the Relevant Label Particulars to include an additional statement ‘Do not use in covered or protected situations such as glass houses, green houses, shade houses or plastic tunnels’ as requested by the APVMA

Date of Variation: 6 November 2013

Label Approval No: 64101/61099

Product Name: Elanco AH0495 Elector PSP Animal Premise Spray

Applicant Name: Elanco Animal Health A Div Of Eli Lilly Aust Pty Ltd

Applicant ACN: 000 233 992

Summary of Variation: To amend spray application instructions by removing advice to use a ‘coarse, low pressure’ spray

Date of Variation: 7 November 2013

Label Approval No: 59422/61040

Product Name: LuciTrap Sheep Blowfly Attractant

Applicant Name: Insect Management Services Pty Ltd

Applicant ACN: 162 387 751

Summary of Variation: To change the product name from ‘LUCILURE SHEEP BLOWFLY ATTRACTANT’ to ‘LUCITRAP SHEEP BLOWFLY ATTRACTANT’, and update the Relevant Label Particulars

Date of Variation: 7 November 2013

Label Approval No: 51198/60728

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Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 11

Notice of Registrations – Agricultural Chemical Products

Product Name: Nufarm Weedmaster DST Dual Salt Technology Herbicide

Applicant Name: Nufarm Australia Limited

Applicant ACN: 004 377 780

Summary of Variation: To change the product name from ‘NUFARM WEEDMASTER DUAL SALT TECHNOLOGY HERBICIDE’ to ‘NUFARM WEEDMASTER DST DUAL SALT TECHNOLOGY HERBICIDE’ and to update to the Relevant Label Particulars

Date of Variation: 12 November 2013

Label Approval No: 62723/60498

Product Name: Hammer 400EC Herbicide

Applicant Name: FMC Australasia Pty Ltd

Applicant ACN: 095 326 891

Summary of Variation: To reduce the withholding period for pasture to nil

Date of Variation: 13 November 2013

Label Approval No: 63228/51559

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Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 12

Notice of Registrations – Veterinary Chemical Products

Veterinary Chemical Products

Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals

Code Act 1994, the APVMA hereby gives notice that it has registered or varied the registration in respect of the following

products, with effect from the dates shown.

1. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Product Name: Optiphos 10000 Microgranulate

Active Constituent/s: 6-phytase (I.U.B. 3.1.3.26): min 10000 FTU/g

Applicant Name: Huvepharma AD

Applicant ACN: N/A

Summary of Use: For use in pigs and poultry to improve the digestibility of feed

Date of Registration: 5 November 2013

Label Approval No: 66424/53612

Product Name: Optiphos 5000 Microgranulate

Active Constituent/s: 6-phytase (I.U.B. 3.1.3.26): min 5000 FTU/g

Applicant Name: Huvepharma AD

Applicant ACN: N/A

Summary of Use: For use in pigs and poultry to improve the digestibility of feed

Date of Registration: 5 November 2013

Label Approval No: 66558/53865

Product Name: Optiphos 10000 Coated

Active Constituent/s: 6-phytase (I.U.B. 3.1.3.26): min 10000 FTU/g

Applicant Name: Huvepharma AD

Applicant ACN: N/A

Summary of Use: For use in pigs and poultry to improve the digestibility of feed

Date of Registration: 5 November 2013

Label Approval No: 66425/53613

Product Name: Optiphos 5000 Coated

Active Constituent/s: 6-phytase (I.U.B. 3.1.3.26): min 5000 FTU/g

Applicant Name: Huvepharma AD

Applicant ACN: N/A

Summary of Use: For use in pigs and poultry to improve the digestibility of feed

Date of Registration: 5 November 2013

Label Approval No: 66557/53864

Product Name: Optiphos 5000 Liquid

Active Constituent/s: 6-phytase (I.U.B. 3.1.3.26): min 5000 FTU/g

Applicant Name: Huvepharma AD

Applicant ACN: N/A

Summary of Use: For use in pigs to improve digestibility of feed

Date of Registration: 5 November 2013

Label Approval No: 66556/53863

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Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 13

Notice of Registrations – Veterinary Chemical Products

Product Name: Optiphos 20000 Liquid

Active Constituent/s: 6-phytase (I.U.B. 3.1.3.26): min 20000 FTU/ml

Applicant Name: Huvepharma AD

Applicant ACN: N/A

Summary of Use: For use in pigs to improve digestibility of feed

Date of Registration: 5 November 2013

Label Approval No: 66426/53614

Product Name: Optiphos 10000 Liquid

Active Constituent/s: 6-phytase (I.U.B. 3.1.3.26): min 10000 FTU/mL

Applicant Name: Huvepharma AD

Applicant ACN: N/A

Summary of Use: For use in pigs to improve the digestibility of feed

Date of Registration: 5 November 2013

Label Approval No: 66555/53862

Product Name: Activyl Spot-On for Extra Large Dogs over 40 kg up to 60 kg

Active Constituent/s: 195 g/L indoxacarb (s-isomer)

Applicant Name: Intervet Australia Pty Limited

Applicant ACN: 008 467 034

Summary of Use: For the control of existing flea infestations and new flea infestations as well as flea allergy dermatitis on dogs

Date of Registration: 6 November 2013

Label Approval No: 64438/48354

Product Name: Vetsense Kilverm Poultry Wormer

Active Constituent/s: 14 g/L levamisole (equivalent to 16.5 g/L levamisole hydrochloride)

Applicant Name: Vetsense Pty Ltd

Applicant ACN: 150 968 871

Summary of Use: For use in treatment of sensitive strains of roundworms in poultry

Date of Registration: 6 November 2013

Label Approval No: 68060/57408

Product Name: Purevet Meloxicam Oral Suspension For Dogs

Active Constituent/s: 1.5 mg/mL meloxicam

Applicant Name: Zoetis Australia Pty Ltd

Applicant ACN: 156 476 425

Summary of Use: For alleviation of inflammation and pain of musculoskeletal disorders in dogs

Date of Registration: 8 November 2013

Label Approval No: 69372/60628

Product Name: Aristopet Animal Health Fly Repellent For Dogs

Active Constituent/s: 13 g/L n-octyl bicycloheptene dicarboximide, 17 g/L di-n-propyl isocinchomeronate, 8 g/L piperonyl butoxide, 17 g/L diethyl toluamide, 5 g/L citronella oil, 2 g/L pyrethrins

Applicant Name: Aristopet Pty Ltd

Applicant ACN: 145 418 882

Summary of Use: An external parasiticide for use on dogs to kill and repel flies

Date of Registration: 11 November 2013

Label Approval No: 69173/60130

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Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 14

Notice of Registrations – Veterinary Chemical Products

Product Name: Aristopet Animal Health Stop-Itch For Dogs & Cats

Active Constituent/s: 15 g/L povidone-iodine, 6 g/L iodophor (equivalent to 0.75% available iodine)

Applicant Name: Aristopet Pty Ltd

Applicant ACN: 145 418 882

Summary of Use: For the treatment of eczema, non-specific dermatoses and fungal infections, including ringworm (Microsporum spp. and Trichophyton spp.) in dogs and cats

Date of Registration: 11 November 2013

Label Approval No: 68944/59447

Product Name: Abbeyneo Antibiotic Feed Additive

Active Constituent/s: 600 g/kg neomycin (as neomycin sulphate)

Applicant Name: Abbey Laboratories Pty Ltd

Applicant ACN: 156 000 430

Summary of Use: For the treatment of bacterial scours caused by organisms sensitive to neomycin, including neomycin sensitive strains of E.coli, Salmonella spp., Pseudomonas spp., in poultry, pigs and cattle

Date of Registration: 12 November 2013

Label Approval No: 67805/56898

2. VARIATIONS

Product Name: Draxxin Injectable Solution

Applicant Name: Zoetis Australia Pty Ltd

Applicant ACN: 156 476 425

Summary of Variation: To extend the use of the product to include dairy heifers up to the point of first mating

Date of Variation: 1 November 2013

Label Approval No: 60018/52864

Product Name: Pastoral AG Ivermectin Pour-On for Cattle

Applicant Name: Titan AG Pty Ltd

Applicant ACN: 122 081 574

Summary of Variation: To change the product name from ‘ECOMECTIN CATTLE POUR-ON’ to ‘PASTORAL AG IVERMECTIN POUR-ON FOR CATTLE’

Date of Variation: 1 November 2013

Label Approval No: 52711/60038

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Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 15

* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer Other Notices – Licensing of Veterinary Chemical Manufacturers

OTHER NOTICES

Licensing of Veterinary Chemical Manufacturers

Pursuant to Part 8 of the Agricultural and Veterinary Chemical Codes scheduled to the Agricultural and Veterinary

Chemicals Code Act 1994, the APVMA hereby gives notice that it has taken action, with respect to the licensing of

the following veterinary chemical manufacturers, with effect from the dates shown.

For a comprehensive listing of all licensed manufacturers please see the APVMA’s website www.apvma.gov.au.

1. NEW LICENCES

BIOPROTON PTY LTD LICENCE NO: 4096

ACN: 059 093 417

55 Dulacca Street

ACACIA RIDGE QLD 4110

Product Types:*

Category 4: premix (powders)

Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation

including blending, packaging, labelling, analysis and testing (enzyme assay),

storage and release for supply.

Licence Issued: 2 October 2013

2. CHANGES TO EXISTING LICENCES

BALHAN INDUSTRIAL CO.

PROPRIETARY LIMITED

LICENCE NO: 2111

ACN: 004 705 435

81–89 Buckley Grove

MOOLAP VIC 3220

Product Types: *

Category 2: pastes, powders and liquids

Step(s) of Manufacture: Formulation including blending, filling, packaging,

labelling, analysis and testing (physical and chemical), storage and release for

supply.

Amended Licence Issued: 4 October 2013

Removal of Category 4

Page 16: APVMA Gazette No. 23, 19 November 2013Nov 19, 2013  · Product Name: Timtech Azguard HF LOSP Wood Preservative Concentrate Active Constituent/s: 16 g/L permethrin, 22.5 g/L propiconazole,

Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 16

* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer Other Notices – Licensing of Veterinary Chemical Manufacturers

THE STATE OF VICTORIA

ACTING THROUGH THE

DEPARTMENT OF

ENVIRONMENT AND PRIMARY

INDUSTRIES

LICENCE NO: 1071

ABN: 90 719 052 204

Pig Health and Research Unit

Corner Taylor Street and

Midland Highway

EPSOM VIC 3551

Product Types: *

Category 1: Bacterial vaccines

Step(s) of Manufacture: Quality assurance (QA) of raw materials, bacterial

fermentation, formulation including blending, aseptic filling, packaging, labelling,

sterilisation (heat), analysis and testing (physical, chemical, microbiological,

sterility, immunobiological, serological and haemolysin assay), storage and

release for supply

Amended Licence Issued: 2 October 2013

Amended company name, ABN and steps of manufacture

PHARMASYNTH PTY LTD

LICENCE NO: 1086

ACN: 074 656 509

2806 Ipswich Road

DARRA QLD 4076

Product Types: *

Category 1: Vaccine and sterile products

Step(s) of Manufacture: Quality assurance (QA) of raw materials, cell

propagation, virus cultivation, filling, packaging, labelling, sterilisation (heat and

filtration), microbiological reduction treatment (heat, filtration, chemical), analysis

and testing (physical), storage.

Amended Licence Issued: 9 October 2013

Amended steps of manufacture

NORTHERN SERUMS PTY LTD LICENCE NO: 1058

ACN: 003 809 318

1295 Hogarth Range Road

HOGARTH RANGE NSW 2469

Product Types: *

Category 1: Immunobiologicals (tick antiserum)

Step(s) of Manufacture: Quality assurance (QA) of raw materials, management

and immunisation of donor animals, serum collection, formulation including

blending, aseptic filling, packaging, labelling, sterilisation (heat, chemical and

filtration), microbiological reduction treatment (heat and filtration), analysis and

testing (physical), storage and release for supply.

Amended Licence Issued: 17 October 2013

Amendment to steps of manufacture

Page 17: APVMA Gazette No. 23, 19 November 2013Nov 19, 2013  · Product Name: Timtech Azguard HF LOSP Wood Preservative Concentrate Active Constituent/s: 16 g/L permethrin, 22.5 g/L propiconazole,

Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 17

* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer Other Notices – Licensing of Veterinary Chemical Manufacturers

RABAR PTY LTD LICENCE NO: 4051

ACN: 010 969 776

152 Enterprise Drive

BEAUDESERT QLD 4285

Product Types: *

Category 4: Supplements (liquids and powders) and premixes

Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation

including blending, wet milling, dry milling, filling, packaging, labelling, analysis

and testing (physical), storage and release for supply

Amended Licence Issued: 25 October 2013

Amended product types

ARISTOPET PTY LTD LICENCE NO: 2211

ACN: 145 418 882

118 Links Avenue South

EAGLE FARM QLD 4009

Product Types: *

Category 2: Tablets, creams/lotions, ointments, pastes, powders, sprays, liquids and suspensions

Category 3: Liquids, sprays, powders and tablets (soluble for aquarium)

Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation

including blending, dry milling, granulation, filling, packaging, labelling, blister

packaging, tableting, analysis and testing (physical), storage and release for

supply.

Amended Licence Issued: 31 October 2013

Amendment to steps of manufacture and key personnel

3. LICENCE CANCELLATIONS

The APVMA has cancelled the following licences under subsection 127(1) of the Agricultural and Veterinary

Chemicals Code [‘the Agvet Code’].

BRIAN F MILLAR TRADING

AS KILLYPTUS PRODUCTS

LICENCE NO: 3018

QLD BN: 5477773

Unit 21, Forest Glen

Shopping Centre

Mons Road

FOREST GLEN QLD 4556

Date Cancelled: 2 October 2013

Reason for Cancellation: s.127(1)(d)

FORT DODGE AUSTRALIA

PTY LIMITED

LICENCE NO: 1005

ACN: 000 074 902

2152 Castlereagh Road

PENRITH NSW 2750

Date Cancelled: 4 October 2013

Reason for Cancellation: s.127(1)(e)

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Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 18

* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer Other Notices – Licensing of Veterinary Chemical Manufacturers

HOSPIRA AUSTRALIA PTY

LTD

LICENCE NO: 1067

ACN: 097 064 330

1–5, 2–10, 7–23, 25–39

Lexia Place

MULGRAVE VIC 3170

Date Cancelled: 11 October 2013

Reason for Cancellation: s.127(1)(d)

BRUCE MALCOLM GRAHAM

TRADING AS: BRUCE

GRAHAM CONSULTING

LICENCE NO: 6143

ABN: 14 644 986 828

1/125-127 Bettington Road

OATLANDS NSW 2117

Date Cancelled: 17 October 2013

Reason for Cancellation: s.127(1)(d)

DEPARTMENT OF PRIMARY

INDUSTRIES AND FISHERIES,

BIOSECURITY SCIENCES

LABORATORY

LICENCE NO: 6146

ABN: 78 342 684 030

665 Fairfield Road

YEERONGPILLY QLD 4105

Date Cancelled: 24 October 2013

Reason for Cancellation: s.127(1)(d)

INTEC INDUSTRIES PTY LTD LICENCE NO: 3034

ACN: 115 361 834

17 Raymond Road

LAVERTON NORTH VIC 3026

Date Cancelled: 14 October 2013

Reason for Cancellation: s.127(1)(d)

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Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 19

* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer Other Notices – Licensing of Veterinary Chemical Manufacturers

4. REVOCATION OF LICENCE CANCELLATION

The APVMA has revoked the cancellation of the following licences under subsection 127(7) of the Agricultural and

Veterinary Chemicals Code [‘the Agvet Code’].

METROPOLITAN HEALTH

SERVICE TRADING AS

PHARMACEUTICAL TESTING

FACILITY (PTF),

DEPARTMENT OF

MICROBIOLOGY, PATHWEST

LABORATORY MEDICINE WA

LICENCE NO: 6097

ABN: 13 993 250 709

Level 3

Hay Street Building

Princess Margaret Hospital for

Children

Roberts Road

SUBIACO WA 6008

Date Cancellation Revoked: 4 October 2013

APVMA CONTACT

MQL Officer

Manufacturing, Quality and Licensing

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4899

Fax: +61 2 6210 4741

Email: [email protected]

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Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 20

Other Notices – Addendum to the Record of Approved Active Constituents

Addendum to the Record of Approved Active Constituents

The current Record of Approved Active Constituents for Registered Chemical Products is also accessible from the

APVMA website, www.apvma.gov.au.

APPROVED SINCE GAZETTE NO. 22

For use in agricultural and/or veterinary chemical products:

Common Name Approval Holder Manufacturer and Site of Manufacture Approval No.

PIRIMICARB SYNGENTA

AUSTRALIA PTY

LTD

Hunan Haili Chemical Industry Co., Ltd

Sujiadu Deshan

Changde

Hunan 415001

P. R. China

69007

BROMADIOLONE ACTIVA S.R.L. Dr Tezza Srl

Via Tre Ponti, 22-37050

S. Maria Di Zevio (VR)

Italy

67898

APVMA CONTACT

For further information please contact:

Application Management and Enquiries

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4701

Fax: +61 2 6210 4721

Email: [email protected]