apvma gazette no. 8, 23 april 2019 · web viewpovidone-iodine applicant name: aristopet pty ltd...

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No. APVMA 8, Tuesday, 23 April 2019 Published by The Australian Pesticides and 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.

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Page 1: APVMA Gazette No. 8, 23 April 2019 · Web viewPovidone-Iodine Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products

No. APVMA 8, Tuesday, 23 April 2019Published by The Australian Pesticides and 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. 8, 23 April 2019 · Web viewPovidone-Iodine Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products

Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Commonwealth of Australia 2023

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:

Assistant Director, Communications

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 required

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 8J(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/news-and-publications/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 4812

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

Page 3: APVMA Gazette No. 8, 23 April 2019 · Web viewPovidone-Iodine Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products

Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

CONTENTS

Agricultural Chemical Products and Approved Labels.............................................................................................................Veterinary Chemical Products and Approved Labels............................................................................................................Approved Active Constituents................................................................................................................................................Frequency Herbicide containing topramezone and cloquintocet-methyl...............................................................................Cancellation of Product Label Approvals at the Request of the Holder.................................................................................

Page 4: APVMA Gazette No. 8, 23 April 2019 · Web viewPovidone-Iodine Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products

Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Agricultural Chemical Products and Approved Labels

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 relevant particulars or conditions of the registration in respect of the following products and has approved the label or varied the relevant particulars or conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.

1. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Application no.: 118727

Product name: Inego 100 EC Herbicide

Active constituent/s: 100 g/L pinoxaden, 25 g/L cloquintocet-mexyl

Applicant name: Adama Australia Pty Ltd

Applicant ACN: 050 328 973

Summary of use: For the control of key grass weeds and selective spray topping of wild oats in wheat and barley

Date of registration: 4 April 2019

Product registration no.:

87594

Label approval no.: 87594/118727

Application no.: 118749

Product name: Yates Home Pest Ant & Nest Kill Gel Bait

Active constituent/s: 0.5 g/kg indoxacarb (S:R 3:1)

Applicant name: Syngenta Australia Pty Ltd

Applicant ACN: 002 933 717

Summary of use: For control of ants in domestic situations

Date of registration: 4 April 2019

Product registration no.:

87602

Label approval no.: 87602/118749

Application no.: 118940

Product name: F.S.A. Imazamox 700 WG Herbicide

Active constituent/s: 700 g/kg imazamox

Applicant name: Four Seasons Agribusiness Pty Ltd

Applicant ACN: 115 133 189

Summary of use: For the post-emergent control of certain annual grass and broadleaf weeds in field peas, legume-based pastures, lucerne, peanuts and soybean

Date of registration: 4 April 2019

Product registration no.:

87676

Label approval no.: 87676/118940

Application no.: 119068

Product name: 4Farmers Terbuthylazine 875 Herbicide

Active constituent/s: 875 g/kg terbuthylazine

Applicant name: 4 Farmers Australia Pty Ltd

Applicant ACN: 160 092 428

Summary of use: For the control of weeds in chickpeas, faba beans, fallows, field peas, lentils, lupins, sorghum and triazine tolerant canola

Date of registration: 4 April 2019

Product registration no.:

87718

Label approval no.: 87718/119068

Agricultural Chemical Products and Approved Labels

Page 5: APVMA Gazette No. 8, 23 April 2019 · Web viewPovidone-Iodine Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products

Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Application no.: 115196

Product name: Atlas Kill & Protect Fast Knockdown Flying Insect Spray

Active constituent/s: 1.0 g/kg esbiothrin, 0.5 g/kg permethrin, 0.2 g/kg imiprothrin

Applicant name: Pascoe's Pty Ltd

Applicant ACN: 055 220 463

Summary of use: For use to control crawling and flying insects around the home and garden

Date of registration: 4 April 2019

Product registration no.:

86269

Label approval no.: 86269/115196

Application no.: 118889

Product name: Koppers H2F Timber Preservative

Active constituent/s: 100 g/L bifenthrin

Applicant name: Koppers Performance Chemicals Australia Pty Ltd

Applicant ACN: 088 260 575

Summary of use: For the protection of timber and timber based products from damage by borers and termites

Date of registration: 8 April 2019

Product registration no.:

87654

Label approval no.: 87654/118889

Application no.: 119259

Product name: IA Acephate 970 SG Insecticide

Active constituent/s: 970 g/kg acephate (an anticholinesterase compound)

Applicant name: Imtrade Australia Pty Ltd

Applicant ACN: 090 151 134

Summary of use: For the control of certain insect pests on bananas, crucifiers, macadamias, ornamentals, potatoes, tomatoes and tobacco

Date of registration: 8 April 2019

Product registration no.:

87788

Label approval no.: 87788/119259

Application no.: 118888

Product name: Gardenline Weed Killer 1-Hour Action

Active constituent/s: 20.5 g/L nonanoic acid, 16 g/L glyphosate present as ammonium salt

Applicant name: Brunnings Garden Products Pty Ltd

Applicant ACN: 050 655 760

Summary of use: For the control of weeds on paths, drives and hard surfaces

Date of registration: 8 April 2019

Product registration no.:

87653

Label approval no.: 87653/118888

Application no.: 119120

Product name: AEC Gibberellic Acid Growth Regulant

Active constituent/s: 200 g/kg gibberellic acid

Applicant name: Australia East Coast Resources Pty Ltd

Applicant ACN: 630 533 916

Summary of use: For foliar spray application to certain varieties of grapes, citrus and prunes to promote desirable harvest effects

Date of registration: 8 April 2019

Product registration no.:

87734

Label approval no.: 87734/119120

Agricultural Chemical Products and Approved Labels

Page 6: APVMA Gazette No. 8, 23 April 2019 · Web viewPovidone-Iodine Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products

Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Application no.: 119074

Product name: Spa Clear Active Spa Sanitiser

Active constituent/s: 504 g/kg available chlorine (Cl) present as sodium dichloroisocyanurate

Applicant name: M I International Pty Ltd

Applicant ACN: 002 869 089

Summary of use: For the control of algae and bacteria in spas and hot tubs

Date of registration: 8 April 2019

Product registration no.:

87724

Label approval no.: 87724/119074

Application no.: 119520

Product name: Spalding Quiz 200 EC Herbicide

Active constituent/s: 200 g/L quizalofop-p-ethyl

Applicant name: Spalding Holdings Pty Ltd

Applicant ACN: 010 155 852

Summary of use: For the control of certain grass weeds in broadleaf crops

Date of registration: 8 April 2019

Product registration no.:

87837

Label approval no.: 87837/119520

2. VARIATIONS OF REGISTRATION

Application no.: 119056

Product name: David Grays Bifenthrin Aqua Termite and Insect Treatment

Active constituent/s: 100 g/L bifenthrin

Applicant name: David Gray & Co Pty Ltd

Applicant ACN: 008 671 127

Summary of variation:

To remove the uses of pre-construction and reticulation from the instructions

Date of variation: 8 February 2019

Product registration no.:

87266

Label approval no.: 87266/119056

Application no.: 119697

Product name: Pool Algaecide Banish

Active constituent/s: 40 g/L copper present as copper sulfate pentahydrate

Applicant name: Biolab Australia Pty Ltd

Applicant ACN: 005 878 017

Summary of variation:

To change the distinguishing product name and the name that appears on the label from ‘Pool Algaecide MSA Extreme’ to ‘Pool Algaecide Banish’

Date of variation: 21 March 2019

Product registration no.:

70178

Label approval no.: 70178/119697

Agricultural Chemical Products and Approved Labels

Page 7: APVMA Gazette No. 8, 23 April 2019 · Web viewPovidone-Iodine Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products

Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Application no.: 119698

Product name: Pool Algaecide MSA Extreme

Active constituent/s: 40 g/L copper as copper (II) sulphate pentahydrate

Applicant name: Biolab Australia Pty Ltd

Applicant ACN: 005 878 017

Summary of variation:

To change the distinguishing product name and the name that appears on the label from ‘Pool Algaecide MSA III’ to ‘Pool Algaecide MSA Extreme’

Date of variation: 21 March 2019

Product registration no.:

49527

Label approval no.: 49527/119698

Application no.: 119848

Product name: F.S.A. Wetter 1040 TX Surfactant

Active constituent/s: 1040 g/L octyl phenol ethoxylate

Applicant name: Four Seasons Agribusiness Pty Ltd

Applicant ACN: 115 133 189

Summary of variation:

To change the distinguishing product name and the name that appears on the label from ‘F.S.A. Wetter 1040 Surfactant’ to ‘F.S.A. Wetter 1040 TX Surfactant’

Date of variation: 29 March 2019

Product registration no.:

87450

Label approval no.: 87450/119848

Application no.: 118632

Product name: Smart Ace 100 Insecticide

Active constituent/s: 100 g/L alpha-cypermethrin

Applicant name: Crop Smart Pty Ltd

Applicant ACN: 093 927 961

Summary of variation:

To update the first aid instructions and storage and disposal statements

Date of variation: 2 April 2019

Product registration no.:

84410

Label approval no.: 84410/118632

Application no.: 118257

Product name: Nufarm Champ Dry Prill WG Fungicide

Active constituent/s: 375 g/kg copper (Cu) present as cupric hydroxide

Applicant name: Nufarm Australia Limited

Applicant ACN: 004 377 780

Summary of variation:

To amend the rate in walnuts

Date of variation: 8 April 2019

Product registration no.:

53935

Label approval no.: 53935/118257

Agricultural Chemical Products and Approved Labels

Page 8: APVMA Gazette No. 8, 23 April 2019 · Web viewPovidone-Iodine Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products

Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Application no.: 113665

Product name: Titan Glyphosate 540 K Salt Herbicide

Active constituent/s: 540 g/L glyphosate present as the potassium salt

Applicant name: Titan Ag Pty Ltd

Applicant ACN: 122 081 574

Summary of variation:

To update signal headings, constituent statements, safety directions and first aid instructions

Date of variation: 8 April 2019

Product registration no.:

65104

Label approval no.: 65104/113665

Application no.: 119426

Product name: Kenso Agcare Ken-Ester LV 680 Selective Herbicide

Active constituent/s: 680 g/L 2,4-D present as the ethylhexyl ester

Applicant name: Kenso Corporation (M) Sdn Bhd

Applicant ACN: N/A

Summary of variation:

To incorporate spray drift instructions from the APVMA’s reconsideration action on 2,4-D

Date of variation:Product registration no.:

8 April 201965224

Label approval no.: 65224/119426

Application no.: 118933

Product name: Richgro Ant Killa

Active constituent/s: 2 g/kg bifenthrin

Applicant name: A Richards Pty Ltd

Applicant ACN: 008 734 852

Summary of variation:

To add a new commercial pack size range (5 kg - 20 kg) and corresponding label statements

Date of variation: 9 April 2019

Product registration no.:

59354

Label approval no.: 59354/118933

Application no.: 115421

Product name: Foragemax Herbicide

Active constituent/s: 100 g/L halauxifen-methyl, 50 g/L aminopyralid present as triisopropanolamine salt

Applicant name: Dow Agrosciences Australia Limited

Applicant ACN: 003 771 659

Summary of variation:

To extend the use to canola and add new weeds

Date of variation: 9 April 2019

Product registration no.:

68249

Label approval no.: 68249/115421

Agricultural Chemical Products and Approved Labels

Page 9: APVMA Gazette No. 8, 23 April 2019 · Web viewPovidone-Iodine Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products

Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Application no.: 119219

Product name: Spalding Chlorothalonil 720 SC Fungicide

Active constituent/s: 720 g/L chlorothalonil

Applicant name: Spalding Holdings Pty Ltd

Applicant ACN: 010 155 852

Summary of variation:

To include uses on pulses and turf

Date of variation: 10 April 2019

Product registration no.:

83251

Label approval no.: 83251/119219

Application no.: 119023

Product name: Titan Pinoxaden 100EC Herbicide

Active constituent/s: 100 g/L pinoxaden, 25 g/L cloquintocet-mexyl

Applicant name: Titan Ag Pty Ltd

Applicant ACN: 122 081 574

Summary of variation:

To add claims to the directions for use

Date of variation: 10 April 2019

Product registration no.:

85289

Label approval no.: 85289/119023

Application no.: 119427

Product name: Premise 200 SC Termiticide

Active constituent/s: 200 g/L imidacloprid

Applicant name: Bayer Cropscience Pty Ltd

Applicant ACN: 000 226 022

Summary of variation:

To amend the general instructions to provide information on termite management practices

Date of variation: 10 April 2019

Product registration no.:

49098

Label approval no.: 49098/119427

Application no.: 118162

Product name: Havoc Herbicide

Active constituent/s: 240 g/L clethodim

Applicant name: Nufarm Australia Limited

Applicant ACN: 004 377 780

Summary of variation:

To extend the use of the product to adzuki beans, broad beans, pasture legumes & seed crops of pasture legumes (lucerne, clover and medic) as well as pastures including lucerne, clover, medic, serradella, chicory and plantain. Other changes include varying the net contents, re-structuring the directions for use, increasing the maximum application rate to 500 mL/ha for all weeds in all crops, as well as including appropriate crop safety and application timing statements

Date of variation: 11 April 2019

Product registration no.:

64796

Label approval no.: 64796/118162

Agricultural Chemical Products and Approved Labels

Page 10: APVMA Gazette No. 8, 23 April 2019 · Web viewPovidone-Iodine Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products

Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Application no.: 119266

Product name: Titan Terbuthylazine 875 WG Herbicide

Active constituent/s: 875 g/kg terbuthylazine

Applicant name: Titan Ag Pty Ltd

Applicant ACN: 122 081 574

Summary of variation:

To add uses in faba beans, field peas, lupins, triazine tolerant canola, lentils, sorghum, fallows, wheat, oats and barley

Date of variation: 11 April 2019

Product registration no.:

84781

Label approval no.: 84781/119266‘Application no.: 118898

Product name: Hit 'Em with the Old Pea Beu Fast Kill Flying Insect Killer Lemon Fresh

Active constituent/s: 3.18 g/kg n-octyl bicycloheptene dicarboximide, 2.17 g/kg piperonyl butoxide, 1.08 g/kg tetramethrin 20:80, 0.25 g/kg phenothrin 20:80

Applicant name: RB (Hygiene Home) Australia Pty Ltd

Applicant ACN: 629 549 506

Summary of variation:

To change the distinguishing product name and the name that appears on the label from ‘Pea Beu Flying Insect Killer Fast Kill Low Irritant Lemon Fresh’ to ‘Hit ‘Em With The Old Pea Beu Fast Kill Flying Insect Killer Lemon Fresh’

Date of variation: 11 April 2019

Product registration no.:

53238

Label approval no.: 53238/118898

Application no.: 119670

Product name: Whitestar Metribuzin WG Herbicide

Active constituent/s: 750 g/kg metribuzin

Applicant name: Agricultural Product Services Pty Ltd

Applicant ACN: 092 350 279

Summary of variation:

To update the poison scheduling from 5 to 6 and update the signal heading from caution to poison

Date of variation: 11 April 2019

Product registration no.:

60976

Label approval no.: 60976/119670

Application no.: 117186

Product name: Manic WG Fungicide Plus

Active constituent/s: 625 g/kg mancozeb

Applicant name: UPL Australia Limited

Applicant ACN: 066 391 384

Summary of variation:

To extend the product shelf life to 36 months

Date of variation: 12 April 2019

Product registration no.:

80787

Label approval no.: 80787/117186

Agricultural Chemical Products and Approved Labels

Page 11: APVMA Gazette No. 8, 23 April 2019 · Web viewPovidone-Iodine Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products

Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Veterinary Chemical Products and Approved Labels

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 relevant particulars or conditions of the registration in respect of the following products and has approved the label or varied the relevant particulars or conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.

1. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Application no.: 116574

Product name: Tranquil Neuroleptic Injection for Pigs

Active constituent/s: 40 mg/mL azaperone

Applicant name: Abbey Laboratories Pty Ltd

Applicant ACN: 156 000 430

Summary of use: For use in pigs with predictable psychomotor sedation

Date of registration: 2 April 2019

Product registration no.:

86787

Label approval no.: 86787/116574

Application no.: 118075

Product name: AbbeyMox SA Amoxycillin Injection

Active constituent/s: 200 mg/mL amoxycillin trihydrate (equivalent to 174.6 mg/mL amoxycillin base)

Applicant name: Abbey Laboratories Pty Ltd

Applicant ACN: 156 000 430

Summary of use: For the treatment of infections susceptible to amoxycillin in cattle, sheep and pigs

Date of registration: 2 April 2019

Product registration no.:

87309

Label approval no.: 87309/118075

Application no.: 118569

Product name: Abantel 35 Broad Spectrum Wormer For Large Dogs

Active constituent/s: 1907 mg/Tb oxantel embonate, 490 mg/Tb pyrantel embonate, 175 mg/Tb praziquantel

Applicant name: Abbey Laboratories Pty Ltd

Applicant ACN: 156 000 430

Summary of use: For the treatment and control of roundworms, hookworms, whipworms and adult tapeworms in dogs

Date of registration: 3 April 2019

Product registration no.:

87509

Label approval no.: 87509/118569

Application no.: 110276

Product name: Cardisure Oral Solution

Active constituent/s: 1.5 mg/mL pimobendan

Applicant name: Dechra Veterinary Products (Australia) Pty Ltd

Applicant ACN: 614 716 700

Summary of use: For the treatment of canine congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid regurgitation)

Date of registration: 4 April 2019

Product registration no.:

84375

Label approval no.: 84375/110276

Veterinary Chemical Products and Approved Labels

Page 12: APVMA Gazette No. 8, 23 April 2019 · Web viewPovidone-Iodine Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products

Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Application no.: 118828

Product name: Purina Totalcare Heartwormer, Allwormer & Flea Control For Cats

Active constituent/s: 60 mg/mL selamectin

Applicant name: Nestle Purina Petcare A Div Of Nestle Australia Ltd

Applicant ACN: 000 011 316

Summary of use: For the treatment and control of flea infestation, ear mites, intestinal hookworm, roundworm in cats, prevention of heartworm disease and treatment of biting lice in cats of 2.6 -7.5 kg body weight. Treatment of ear mites, sarcoptic mange and cheyletiellosis in rabbits of 2.6 -7.5 kg body weight

Date of registration: 5 April 2019

Product registration no.:

87627

Label approval no.: 87627/118828

Application no.: 118932

Product name: Moxi LA Long Acting Injection for Cattle

Active constituent/s: 100 mg/mL moxidectin

Applicant name: Abbey Laboratories Pty Ltd

Applicant ACN: 156 000 430

Summary of use: For the treatment and control of moxidectin-sensitive internal and external parasites in cattle

Date of registration: 5 April 2019

Product registration no.:

87671

Label approval no.: 87671/118932

Application no.: 119469

Product name: Covine Emperor Pour-On For Beef And Dairy Cattle And Deer

Active constituent/s: 5 mg/mL eprinomectin

Applicant name: Ruralco Holdings Limited

Applicant ACN: 009 660 879

Summary of use: For the treatment and control of internal and external parasites of beef and dairy cattle and internal parasites of deer

Date of registration: 8 April 2019

Product registration no.:

87813

Label approval no.: 87813/119469

Application no.: 119139

Product name: Independents Own Sureshot Duo Combination Pour-On For Cattle

Active constituent/s: 200 mg/mL levamisole, 10 mg/mL abamectin

Applicant name: Vetpharm Pty Ltd

Applicant ACN: 629 894 086

Summary of use: For treatment and control of roundworms including macrocyclic lactone or levamisole resistant strains and external parasites in cattle

Date of registration: 9 April 2019

Product registration no.:

87741

Label approval no.: 87741/119139

Veterinary Chemical Products and Approved Labels

Page 13: APVMA Gazette No. 8, 23 April 2019 · Web viewPovidone-Iodine Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products

Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Application no.: 119491

Product name: Nutriject Injection for Cattle

Active constituent/s: 40 g/L zinc as disodium zinc EDTA, 15 g/L copper as disodium copper EDTA,10 g/L manganese as disodium manganese EDTA, 5 g/L selenium as sodium selenite

Applicant name: Virbac Australia Pty Ltd

Applicant ACN: 003 268 871

Summary of use: For use in beef and dairy cattle deficient in and/or responsive to manganese, zinc, selenium and/or copper supplementation

Date of registration: 11 April 2019

Product registration no.:

87829

Label approval no.: 87829/119491

2. VARIATIONS OF REGISTRATION

Application no.: 119727

Product name: Omoguard Defender Oral Paste for Horses

Active constituent/s: 92.5 mg/g omeprazole

Applicant name: Ceva Animal Health Pty Ltd

Applicant ACN: 002 692 426

Summary of variation:

To change the distinguishing product name and the name that appears on the label from ‘Omoshield Oral Paste For Horses’ to ‘Omoguard Defender Oral Paste For Horses’

Date of variation: 26 March 2019

Product registration no.:

85518

Label approval no.: 85518/119727

Application no.: 119781

Product name: Randlab TMPS Oral Paste For Horses

Active constituent/s: 400 mg/g sulfadiazine, 86 mg/g trimethoprim

Applicant name: Randlab Australia Pty Ltd

Applicant ACN: 114 948 837

Summary of variation:

To change the distinguishing product name and the name that appears on the label from ‘Sulfatrim Oral Paste’ to ‘Randlab TMPS Oral Paste For Horses’

Date of variation: 28 March 2019

Product registration no.:

83452

Label approval no.: 83452/119781

Application no.: 118738

Product name: Elanco AH0487 Demize Pour-On for Cattle

Active constituent/s: 25 g/L zeta-cypermethrin

Applicant name: Elanco Australasia Pty Ltd

Applicant ACN: 076 745 198

Summary of variation:

To update an approved warning statement and to update the label in accordance with the vet labelling code

Date of variation: 1 April 2019

Product registration no.:

50781

Label approval no.: 50781/118738

Veterinary Chemical Products and Approved Labels

Page 14: APVMA Gazette No. 8, 23 April 2019 · Web viewPovidone-Iodine Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products

Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Application no.: 116173

Product name: Clik Spray-On Sheep Blowfly Treatment

Active constituent/s: 50 g/L dicyclanil

Applicant name: Elanco Australasia Pty Ltd

Applicant ACN: 076 745 198

Summary of variation:

To amend the export slaughter interval

Date of variation: 5 April 2019

Product registration no.:

50005

Label approval no.: 50005/116173

Application no.: 119524

Product name: Razor Equine Wormer

Active constituent/s: 100 mg/g praziquantel, 8 mg/g ivermectin

Applicant name: Virbac (Australia) Pty Ltd

Applicant ACN: 003 268 871

Summary of variation:

To add a pack size containing 100 x 30mL multi-dose syringes in a carton

Date of variation: 9 April 2019

Product registration no.:

59467

Label approval no.: 59467/119524

Application no.: 116508

Product name: Apomorphine Emetic Tablets

Active constituent/s: 6.5 mg/Tb apomorphine hydrochloride

Applicant name: Jurox Pty Ltd

Applicant ACN: 000 932 230

Summary of variation:

To change safety statements to directions for use contraindications, precautions and side effects statements

Date of variation: 10 April 2019

Product registration no.:

48380

Label approval no.: 48380/116508

Application no.: 117070

Product name: Metacam 0.5 mg/mL Oral Suspension For Cats

Active constituent/s: 0.5 mg/mL meloxicam

Applicant name: Boehringer Ingelheim Animal Health Australia Pty Ltd

Applicant ACN: 071 187 285

Summary of variation:

To extend product use to guinea pigs

Date of variation: 11 April 2019

Product registration no.:

61575

Label approval no.: 61575/117070

Veterinary Chemical Products and Approved Labels

Page 15: APVMA Gazette No. 8, 23 April 2019 · Web viewPovidone-Iodine Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products

Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Approved Active Constituents

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 approved or varied the relevant particulars or conditions of the approval of the following active constituents, with effect from the dates shown.

1. ACTIVE CONSTITUENT

Application no.: 116303

Active constituent/s:

gibberellic acid

Applicant name: Fine Agrochemicals Limited

Applicant ACN: N/A

Summary of use: For use in agricultural chemical products

Date of approval: 8 April 2019

Approval no.: 86659

Application no.: 117538

Active constituent/s:

Monensin Sodium

Applicant name: Phibro Animal Health Pty Limited

Applicant ACN: 093 869 991

Summary of variation:

Variation of relevant particulars or conditions of an approved active constituent

Date of variation: 19 February 2019

Approval no.: 82398

Application no.: 117538

Active constituent/s:

Monensin Sodium

Applicant name: Phibro Animal Health Pty Limited

Applicant ACN: 093 869 991

Summary of variation:

Variation of relevant particulars or conditions of an approved active constituent

Date of variation: 19 February 2019

Approval no.: 82398

Application no.: 118160

Active constituent/s:

Flunixin Meglumine

Applicant name: Randlab Australia Pty Ltd

Applicant ACN: 114 948 837

Summary of use: For use in veterinary chemical products

Date of approval: 22 February 2019

Approval no.: 87344

Application no.: 118504

Active constituent/s:

Povidone-Iodine

Applicant name: Aristopet Pty Ltd

Applicant ACN: 145 418 882

Summary of use: For use in veterinary chemical products

Date of approval: 22 February 2019

Approval no.: 87493

Approved Active Constituents

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Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Application no.: 118322

Active constituent/s:

Albendazole

Applicant name: Virbac (Australia) Pty Ltd

Applicant ACN: 003 268 871

Summary of use: For use in veterinary chemical products

Date of approval: 22 February 2019

Approval no.: 87421

Application no.: 117218

Active constituent/s:

Cloxacillin benzathine

Applicant name: Bayer Australia Ltd (Animal Health)

Applicant ACN: 000 138 714

Summary of use: For use in veterinary chemical products

Date of approval: 22 February 2019

Approval no.: 86979

Application no.: 118326

Active constituent/s:

Albendazole

Applicant name: Virbac (Australia) Pty Ltd

Applicant ACN: 003 268 871

Summary of use: For use in veterinary chemical products

Date of approval: 26 February 2019

Approval no.: 87425

Application no.: 118266

Active constituent/s:

Monensin Sodium

Applicant name: Phibro Animal Health Pty Limited

Applicant ACN: 093 869 991

Summary of use: For use in veterinary chemical products

Date of approval: 26 February 2019

Approval no.: 87397

Application no.: 119000

Active constituent/s:

Isoflurane

Applicant name: Zoetis Australia Pty Ltd

Applicant ACN: 156 476 425

Summary of use: For use in veterinary chemical products

Date of approval: 27 February 2019

Approval no.: 87697

Application no.: 118855

Active constituent/s:

Chlorfenvinphos

Applicant name: Zoetis Australia Pty Ltd

Applicant ACN: 156 476 425

Summary of use: For use in veterinary chemical products

Date of approval: 28 February 2019

Approval no.: 87641

Approved Active Constituents

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Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Application no.: 118258

Active constituent/s:

Oxibendazole

Applicant name: Virbac (Australia) Pty Ltd

Applicant ACN: 003 268 871

Summary of use: For use in veterinary chemical products

Date of approval: 28 February 2019

Approval no.: 87394

Application no.: 114071

Active constituent/s:

Oxytetracycline Hydrochloride

Applicant name: Alltech Lienert Australia Pty. Ltd.

Applicant ACN: 008 293 007

Summary of use: For use in veterinary chemical products

Date of approval: 1 March 2019

Approval no.: 85793

Application no.: 116572

Active constituent/s:

Azaperone

Applicant name: Abbey Laboratories Pty Ltd

Applicant ACN: 156 000 430

Summary of use: For use in veterinary chemical products

Date of approval: 1 March 2019

Approval no.: 86785

Application no.: 118280

Active constituent/s:

Tylosin

Applicant name: Huvepharma EOOD

Applicant ACN: 156 000 430

Summary of use: For use in veterinary chemical products

Date of approval: 5 March 2019

Approval no.: 87403

Application no.: 115595

Active constituent/s:

Chlortetracycline Hydrochloride

Applicant name: Dox-Al Australia Pty Ltd

Applicant ACN: 079 454 265

Summary of use: For use in veterinary chemical products

Date of approval: 6 March 2019

Approval no.: 86373

Application no.: 118411

Active constituent/s:

Abamectin

Applicant name: Randlab Australia Pty Ltd

Applicant ACN: 114 948 837

Summary of use: For use in veterinary chemical products

Date of approval: 8 March 2019

Approval no.: 87463

Approved Active Constituents

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Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Application no.: 118649

Active constituent/s:

Isoflurane

Applicant name: Kahu Veterinary Equipment Limited

Applicant ACN: 609 611 109

Summary of use: For use in veterinary chemical products

Date of approval: 21 March 2019

Approval no.: 87551

Application no.: 118660

Active constituent/s:

Lincomycin Hydrochloride

Applicant name: South Yarra Pharma Pty Ltd

Applicant ACN: 629 173 351

Summary of use: For use in veterinary chemical products

Date of approval: 21 March 2019

Approval no.: 87556

Application no.: 118302

Active constituent/s:

Butorphanol Tartrate

Applicant name: Randlab Australia Pty Ltd

Applicant ACN: 114 948 837

Summary of use: For use in veterinary chemical products

Date of approval: 27 March 2019

Approval no.: 87404

Application no.: 119148

Active constituent/s:

Oxytetracycline Hydrochloride

Applicant name: Zoetis Australia Pty Ltd

Applicant ACN: 156 476 425

Summary of use: For use in veterinary chemical products

Date of approval: 27 March 2019

Approval no.: 87747

Application no.: 118928

Active constituent/s:

Doramectin

Applicant name: Norbrook Laboratories Australia Pty Limited

Applicant ACN: 080 972 596

Summary of use: For use in veterinary chemical products

Date of variation: 16 April 2019

Approval no.: 87669

2. VARIATIONS OF ACTIVE CONSTITUENT

Application no.: 118343

Active constituent/s:

Thiamine Disulfide Nitrate

Applicant name: Ceva Animal Health Pty Ltd

Applicant ACN: 002 692 426

Summary of variation:

Variation of relevant particulars or conditions of an approved active constituent

Date of variation: 26 February 2019

Approval no.: 83469

Approved Active Constituents

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Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Application no.: 118847

Active constituent/s:

Thiamine Disulfide Nitrate

Applicant name: Troy Laboratories Pty Ltd

Applicant ACN: 000 283 769

Summary of variation:

Variation of relevant particulars or conditions of an approved active constituent

Date of variation: 15 April 2019

Approval no.: 85657

Approved Active Constituents

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Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Frequency Herbicide containing topramezone and cloquintocet-methyl

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for registration of a new product containing a new active constituent topramezone, in combination with the active cloquintocet-mexyl. The product is FREQUENCY HERBICIDE.

PARTICULARS OF THE APPLICATION

Proposed product name(s): FREQUENCY HERBICIDE

Applicant company: BASF Australia Ltd

Name of active constituent: Topramezone and cloquintocet-mexyl

Signal heading: Schedule 5 (Caution)

Summary of proposed use: For post-emergence weed control in winter wheat, barley and durum.

Pack sizes: 5 L, 10 L, 15 L, 20 L, 110 L and 1000 L

Withholding period: Harvest: Not required when used as directedGrazing: DO NOT graze or cut for stock food for 6 weeks after application. When applying with a tank mix product, observe the grazing withholding period for the tank mix product if this is longer than 6 weeks.

SUMMARY OF THE APVMA’S EVALUATION OF FREQUENCY HERBICIDE IN ACCORDANCE WITH THE REQUIREMENTS OF SECTION 14(1)(C) OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE (THE ‘AGVET CODE’), SCHEDULED TO THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994

1. The APVMA has evaluated the application and in its assessment in relation to whether the safety criteria have been met in accordance with the definition set out in section 5A of the Agvet Code, and proposes to determine that:

(i) The APVMA is satisfied that the proposed use of FREQUENCY HERBICIDE would not be an undue hazard to the safety of people exposed to it during its handling and use.

(ii) The APVMA is satisfied that the proposed use of FREQUENCY HERBICIDE will not be an undue hazard to the safety of people using anything containing its residues.

(iii) The APVMA is satisfied that the proposed use of FREQUENCY HERBICIDE containing the active constituent topramezone and cloquintocet-mexyl is not likely to be harmful to human beings if used according to the product label directions.

(iv) The APVMA is satisfied that the proposed use of FREQUENCY HERBICIDE containing the active constituent topramezone and cloquintocet-mexyl is not likely to have an unintended effect that is harmful to animals, plants or the environment if used according to the product label directions.

2. The APVMA has evaluated the application and in its assessment in relation to whether the efficacy criteria have been met in accordance with the definition set out in section 5B of the Agvet Code, and proposes to determine that:

Frequency Herbicide containing topramezone and cloquintocet-methyl

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Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

(i) In relation to its assessment of efficacy under section 14(3)(f), the APVMA is satisfied that data from trials supporting the efficacy of the product adequately demonstrate that if used according to the product label directions, the product is effective for its proposed uses.

3. The APVMA has evaluated the application and in its assessment in relation to whether the trade criteria have been met in accordance with the definition set out in section 5C of the Agvet Code, and proposes to determine that:

(ii) The APVMA is satisfied that the proposed use of FREQUENCY HERBICIDE would not adversely affect trade between Australia and places outside Australia.

FURTHER INFORMATION

A Public Release Summary (PRS) of the evaluation of this product is available from the APVMA website’s ‘Public Consultation’ page, www.apvma.gov.au/consultation/public or by contacting the APVMA via details listed below.

MAKING A SUBMISSION

In accordance with section13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether FREQUENCY HERBICIDE should be registered. Submissions should relate only to matters that are required by the APVMA to be taken into consideration in determining whether the safety, efficacy or trade criteria have been met. Submissions should state the grounds on which they are based.

Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.

Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered and in determining appropriate conditions of registration and product labelling.

When making a submission please include:

contact name company or group name (if relevant) email or postal address the date you made the submission.

All personal and confidential commercial information (CCI) material contained in submissions will be treated confidentially.

Written submissions should be addressed in writing to:

Case Management and Administration Unit

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]

Frequency Herbicide containing topramezone and cloquintocet-methyl

Page 22: APVMA Gazette No. 8, 23 April 2019 · Web viewPovidone-Iodine Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products

Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Cancellation of Product Label Approvals at the Request of the Holder

At the request of the holder, the APVMA has cancelled the product label approvals for the following products:

Product no. Product name Registrant Product label approval number

Date of effect

30613 Antracol Fungicide Spray

Bayer Cropscience Pty Ltd

30613/1202 14 December 2018

The following instructions set out how a person can deal with the product bearing the cancelled product label.

SUPPLY

A person may supply or cause to be supplied the above product(s) bearing the cancelled label manufactured prior to 14 December 2018 at wholesale and retail level, until 14 December 2019.

After 14 December 2019 it will be an offence against the Agvet Codes to have possession or custody of the product(s) bearing the cancelled label with the intention to supply, or to supply the product.

USE

A person may continue to use the product(s) bearing the cancelled label according to its label instructions until 14 December 2019.

Any person who possesses, has custody of, uses, or otherwise deals with the listed product bearing the cancelled label in accordance with the above instructions is taken to have been issued with a permit under the Agvet Codes to so possess, have custody of, use or otherwise deal with the product(s) bearing the cancelled label until 14 December 2019.

The supply and use of the product(s) bearing the cancelled label must be in accordance with the conditions of registration or approval, including any conditions relating to the shelf life or expiry date.

It is an offence to possess, have custody of, use, or deal with the product(s) bearing the cancelled label listed in the table in a manner that contravenes the above instructions.

APVMA CONTACT

For any enquiries or further information about this matter, please contact:

Chemical ReviewAustralian Pesticides and Veterinary Medicines AuthorityPO Box 6182SYMONSTON ACT 2609

Phone: +61 2 6210 4779Fax: +61 2 6210 4776Email: [email protected]

Cancellation of Product Label Approvals at the Request of the Holder

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Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Cancellation of Product Label Approvals at the Request of the Holder

At the request of the holder, the APVMA has cancelled the product label approvals for the following products:

Product no. Product name Registrant Product label approval number

Date of effect

63123 Cheminova Pirimicarb WG Aphicide

FMC Australasia Pty Ltd

63123/61833

63123/0608

30 January 2019

The following instructions set out how a person can deal with the product bearing the cancelled product label.

SUPPLY

A person may supply or cause to be supplied the above product(s) bearing the cancelled label manufactured prior to 30 January 2019 at wholesale and retail level, until 30 January 2020.

After 30 January 2020 it will be an offence against the Agvet Codes to have possession or custody of the product(s) bearing the cancelled label with the intention to supply, or to supply the product.

USE

A person may continue to use the product(s) bearing the cancelled label according to its label instructions until 30 January 2020.

Any person who possesses, has custody of, uses, or otherwise deals with the listed product bearing the cancelled label in accordance with the above instructions is taken to have been issued with a permit under the Agvet Codes to so possess, have custody of, use or otherwise deal with the product(s) bearing the cancelled label until 30 January 2020.

The supply and use of the product(s) bearing the cancelled label must be in accordance with the conditions of registration or approval, including any conditions relating to the shelf life or expiry date.

It is an offence to possess, have custody of, use, or deal with the product(s) bearing the cancelled label listed in the table in a manner that contravenes the above instructions.

APVMA CONTACT

For any enquiries or further information about this matter, please contact:

Chemical ReviewAustralian Pesticides and Veterinary Medicines AuthorityPO Box 6182SYMONSTON ACT 2609

Phone: +61 2 6210 4779Fax: +61 2 6210 4776Email: [email protected]

Cancellation of Product Label Approvals at the Request of the Holder

Page 24: APVMA Gazette No. 8, 23 April 2019 · Web viewPovidone-Iodine Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products

Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Cancellation of Product Label Approvals at the Request of the Holder

At the request of the holder, the APVMA has cancelled the product label approvals for the following products:

Product no.

Product name Registrant Product label approval number

Date of effect

68502 Virkon S Tablets Broad Spectrum Virucidal Bacterial Fungicidal Disinfectant

Alltech Lienert Australia Pty Ltd

68502/100655 31 January 2019

56946 Imtrade Assassinator 400 Insecticide

Imtrade Australia Pty Ltd

56946/0715 31 January 2019

The following instructions set out how a person can deal with the product(s) bearing the cancelled product label.

SUPPLY

A person may supply or cause to be supplied the above product(s) bearing the cancelled label manufactured prior to 31 January 2019 at wholesale and retail level, until 31 January 2020.

After 31 January 2020 it will be an offence against the Agvet Codes to have possession or custody of the product(s) bearing the cancelled label with the intention to supply, or to supply the product(s).

USE

A person may continue to use the product(s) bearing the cancelled label according to its label instructions until 31 January 2019.

Any person who possesses, has custody of, uses, or otherwise deals with the listed product bearing the cancelled label in accordance with the above instructions is taken to have been issued with a permit under the Agvet Codes to so possess, have custody of, use or otherwise deal with the product bearing the cancelled label until 31 January 2019.

The supply and use of the product(s) bearing the cancelled label must be in accordance with the conditions of registration or approval, including any conditions relating to the shelf life or expiry date.

It is an offence to possess, have custody of, use, or deal with the product(s) bearing the cancelled label listed in the table in a manner that contravenes the above instructions.

APVMA CONTACT

For any enquiries or further information about this matter, please contact:

Chemical Review

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

SYMONSTON ACT 2609

Phone: +61 2 6210 4779

Fax: +61 2 6210 4776

Email: [email protected]

Cancellation of Product Label Approvals at the Request of the Holder

Page 25: APVMA Gazette No. 8, 23 April 2019 · Web viewPovidone-Iodine Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products

Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Cancellation of Product Label Approvals at the Request of the Holder

At the request of the holder, the APVMA has cancelled the product label approvals for the following products:

Product no. Product name Registrant Product label approval number

Date of effect

65405 Titan Fenamiphos 400 Nematicide Liquid

Titan Ag Pty Ltd 65405/0715 11 April 2019

53306 Echem Abamectin Insecticide / Miticide

Echem (Aust) Pty Limited

53306/0204

53306/0900

11 April 2019

54934 Blitzem! Insect Killer Concentrate

Duluxgroup (Australia) Pty Ltd

54934/1107

54934/0402

11 April 2019

68038 Kenso Agcare Abaken 18 Insecticide / Miticide

Kenso Corporation (M) SDN BHD

68038/57331 11 April 2019

53511 Cropro Stealth Miticide and Insecticide

PCT Holdings Pty Ltd

53511/0907

53511/1000

11 April 2019

69011 Farmalinx Neptune 400 EC Nematicide and Insecticide

Farmalinx Pty Ltd 69011/0715 11 April 2019

63204 Accensi Chlorothalonil 720 Fungicide

Accensi Pty Ltd 63204/0708

63204/59876

11 April 2019

68767 Sunphosate 680 WG Herbicide

Zhejiang Xinan Chemical Industrial Group Co., Ltd

68767/59039 11 April 2019

70284 Imtrade Nosclex 800 WG Fungicide

Imtrade Australia Pty Ltd

70284/105484

70284/62931

11 April 2019

67759 Pacific Tri-Allate 500 Selective Herbicide

Pacific Agriscience Pty Ltd

67759/56811 11 April 2019

58704 Rebound WP Fungicide

Kiwi Rural Trading Pty Ltd

58704/61751

58704/0206

11 April 2019

The following instructions set out how a person can deal with the product bearing the cancelled product label.

SUPPLY

A person may supply or cause to be supplied the above product(s) bearing the cancelled label manufactured prior to 11 April 2019 at wholesale and retail level, until 11 April 2020.

Cancellation of Product Label Approvals at the Request of the Holder

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Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

After 11 April 2020 it will be an offence against the Agvet Codes to have possession or custody of the product bearing the cancelled label with the intention to supply, or to supply the product.

USE

A person may continue to use the product bearing the cancelled label according to its label instructions until 11 April 2020.

Any person who possesses, has custody of, uses, or otherwise deals with the listed product bearing the cancelled label in accordance with the above instructions is taken to have been issued with a permit under the Agvet Codes to so possess, have custody of, use or otherwise deal with the product(s) bearing the cancelled label until 12 April 2020.

The supply and use of the product bearing the cancelled label must be in accordance with the conditions of registration or approval, including any conditions relating to the shelf life or expiry date.

It is an offence to possess, have custody of, use, or deal with the product(s) bearing the cancelled label listed in the table in a manner that contravenes the above instructions.

APVMA CONTACT

For any enquiries or further information about this matter, please contact:

Chemical Review Australian Pesticides and Veterinary Medicines AuthorityPO Box 6182SYMONSTON ACT 2609

Phone: +61 2 6210 4779Fax: +61 2 6210 4776

Email: [email protected]

Cancellation of Product Label Approvals at the Request of the Holder

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Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Cancellation of Product Label Approvals at the Request of the Holder

At the request of the holder, the APVMA has cancelled the product label approvals for the following products:

Table 1 Product no. (A)

Product name (B) Registrant (C) Product label approval number (D)

Date of effect (E)

63494 Accensi Procymidone 500 Fungicide

Accensi Pty Ltd 63494/59812

63494/1008

12 April 2019

65691 Viralfx the broad spectrum virucidal, bacterial, fungicidal disinfectant and cleaner

Spick N Clean Products Pty Ltd

65691/51590 10 April 2019

The following instructions set out how a person can deal with the product bearing the cancelled product label.

SUPPLY

A person may supply or cause to be supplied the above product(s) bearing the cancelled label manufactured prior to the date in Column E in table 1, at wholesale and retail level, until 12 months from the date listed in Column E of Table 1.

After 12 months from the date listed in Column E Table 1, it will be an offence against the Agvet Codes to have possession or custody of the product(s) bearing the cancelled label with the intention to supply, or to supply the product.

USE

A person may continue to use the product(s) bearing the cancelled label according to its label instructions until 12 months after the date listed in Column E of Table 1.

Any person who possesses, has custody of, uses, or otherwise deals with the listed product bearing the cancelled label in accordance with the above instructions is taken to have been issued with a permit under the Agvet Codes to so possess, have custody of, use or otherwise deal with the product(s) bearing the cancelled label until 12 months from the date listed in Column E of Table 1.

The supply and use of the product(s) bearing the cancelled label must be in accordance with the conditions of registration or approval, including any conditions relating to the shelf life or expiry date.

It is an offence to possess, have custody of, use, or deal with the product(s) bearing the cancelled label listed in the table in a manner that contravenes the above instructions.

Cancellation of Product Label Approvals at the Request of the Holder

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Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

APVMA CONTACT

For any enquiries or further information about this matter, please contact:

Chemical ReviewAustralian Pesticides and Veterinary Medicines AuthorityPO Box 6182SYMONSTON ACT 2609

Phone: +61 2 6210 4779Fax: +61 2 6210 4776Email: [email protected]

Cancellation of Product Label Approvals at the Request of the Holder

Page 29: APVMA Gazette No. 8, 23 April 2019 · Web viewPovidone-Iodine Applicant name: Aristopet Pty Ltd Applicant ACN: 145 418 882 Summary of use: For use in veterinary chemical products

Commonwealth of Australia GazetteNo. APVMA 8, Tuesday, 23 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Cancellation of Product Label Approvals at the Request of the Holder

At the request of the holder, the APVMA has cancelled the product label approvals for the following products:

Product no. Product name Registrant Product label approval number

Date of effect

48870 Spreadwet 600 Wetting Agent

SST Australia Pty Ltd 48870/01 12 April 2019

The following instructions set out how a person can deal with the product bearing the cancelled product label.

SUPPLY

A person may supply or cause to be supplied the above product(s) bearing the cancelled label manufactured prior to 12 April 2019 at wholesale and retail level, until 12 April 2020.

After 12 April 2020 it will be an offence against the Agvet Codes to have possession or custody of the product bearing the cancelled label with the intention to supply, or to supply the product.

USE

A person may continue to use the product bearing the cancelled label according to its label instructions until 12 April 2020.

Any person who possesses, has custody of, uses, or otherwise deals with the listed product bearing the cancelled label in accordance with the above instructions is taken to have been issued with a permit under the Agvet Codes to so possess, have custody of, use or otherwise deal with the product(s) bearing the cancelled label until 12 April 2020.

The supply and use of the product bearing the cancelled label must be in accordance with the conditions of registration or approval, including any conditions relating to the shelf life or expiry date.

It is an offence to possess, have custody of, use, or deal with the product(s) bearing the cancelled label listed in the table in a manner that contravenes the above instructions.

APVMA CONTACT

For any enquiries or further information about this matter, please contact:

Chemical ReviewAustralian Pesticides and Veterinary Medicines AuthorityPO Box 6182SYMONSTON ACT 2609

Phone: +61 2 6210 4779Fax: +61 2 6210 4776Email: [email protected].

Cancellation of Product Label Approvals at the Request of the Holder