apvma gazette no. 2, 24 january 2017. apvma 2, tuesday, 24 january 2017 agricultural and veterinary...

No. APVMA 2, Tuesday, 24 January 2017 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.

ISSN 1837 - 7629

Commonwealth of Australia Gazette No. APVMA 2, Tuesday, 24 January 2017 Agricultural and Veterinary Chemicals Code Act 1994 2

Commonwealth of Australia 2017

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:

Director, Public Affairs and 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

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www.apvma.gov.au/news-and-publications/publications/gazette

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APVMA CONTACTS

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

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http://www.apvma.gov.au/news-and-publications/publications/gazette


CONTENTS

Agricultural Chemical Products and Approved Labels..................................................................................................... 4 Veterinary Chemical Products and Approved Labels .................................................................................................... 12 Approved Active Constituents ....................................................................................................................................... 18 Licensing of Veterinary Chemical Manufacturers .......................................................................................................... 20


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.: 107266 Product name: Biosmarte Trash Bin Fly Killer Active constituent/s: 7.8 g/kg transfluthrin Applicant name: Smartec Solutions Ltd Applicant ACN: N/A Summary of use For the control of flies in industrial bins Date of registration: 21 December 2016 Product registration no.: 82988 Label approval no.: 82988/107266

Application no.: 101299 Product name: Infinito SC Fungicide Active constituent/s: 625 g/L propamocarb hydrochloride, 62.5 g/L fluopicolide Applicant name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of use For control of late blight in potatoes and downy mildew in lettuce, cucurbits, bulb vegetables

and poppies Date of registration: 23 December 2016 Product registration no.: 80625 Label approval no.: 80625/101299

Application no.: 109014 Product name: Mortein Home Expert Multi Insect Killer Active constituent/s: 1.5 g/kg imiprothrin, 1 g/kg esbiothrin, 0.3 g/kg permethrin Applicant name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of use For control of crawling and flying insects in household situations Date of registration: 23 December 2016 Product registration no.: 83812 Label approval no.: 83812/109014

Application no.: 102762 Product name: Macphersons Protea 800 EC Herbicide Active constituent/s: 800 g/L prosulfocarb Applicant name: TGAC Australia Pty. Ltd Applicant ACN: 134 570 700 Summary of use For the control of annual ryegrass (lolium rigidum) in barley and wheat Date of registration: 23 December 2016 Product registration no.: 81295 Label approval no.: 81295/102762



Application no.: 108107 Product name: International Trilux Antifouling For Aluminium Active constituent/s: Red Label

136 g/L copper (cu) present as cuprous thiocyanate, 57 g/L zinc pyrithione Black Label 141 g/L copper (cu) present as cuprous thiocyanate, 57 g/L zinc pyrithione Blue Label 140 g/L copper (cu) present as cuprous thiocyanate, 57 g/L zinc pyrithione White Label 138 g/L copper (cu) present as cuprous thiocyanate, 56 g/L zinc pyrithione Gray Label 156 g/L copper (cu) present as cuprous thiocyanate, 63 g/L zinc pyrithione

Applicant name: Akzo Nobel Pty Limited Applicant ACN: 000 119 424 Summary of use For use as an antifouling paint for the control of marine growth below the waterline on

vessels Date of registration: 4 January 2017 Product registration no.: 83351 Label approval no.: 83351/108107

Application no.: 107260 Product name: Titan Lambda-Cyhalothrin 250 CS Insecticide Active constituent/s: 250 g/L lambda-cyhalothrin Applicant name: Titan Ag Pty Ltd Applicant ACN: 122 081 574 Summary of use For the control of certain insect pests in cotton, wheat, barley and other crops Date of registration: 5 January 2017 Product registration no.: 82982 Label approval no.: 82982/107260

Application no.: 107383 Product name: Relyon Diz 38 Cotton Growth Regulator Active constituent/s: 38 g/L mepiquat (present as the chloride) Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of use For the management of fruiting and excessive vegetative growth in cotton Date of registration: 5 January 2017 Product registration no.: 83048 Label approval no.: 83048/107383

Application no.: 107507 Product name: Relyon Flash 240 Herbicide Active constituent/s: 240 g/L imazapic present as the ammonium salt Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 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: 5 January 2017 Product registration no.: 83090 Label approval no.: 83090/107507



Application no.: 107732 Product name: Relyon Suspectin 18EC Insecticide/Miticide Active constituent/s: 18 g/L abamectin Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of use For the control of pest mites on pears, apples, tomatoes, citrus, hops, strawberries and

ornamentals. For the control of pest mites and native budworm on cotton Date of registration: 5 January 2017 Product registration no.: 83210 Label approval no.: 83210/107732

Application no.: 107639 Product name: Genfarm Prosulfocarb 800 EC Herbicide Active constituent/s: 800 g/L prosulfocarb Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of use For control of annual ryegrass in wheat and barley Date of registration: 5 January 2017 Product registration no.: 83150 Label approval no.: 83150/107639

Application no.: 109071 Product name: First Force Multi Purpose Insect Killer Active constituent/s: 0.9 g/kg d-allethrin 20:80, 0.9 g/kg d-phenothrin, 4.05 g/kg tetramethrin 20:80 Applicant name: Aaron Laboratories Proprietary Limited Applicant ACN: 004 856 848 Summary of use For protection against ants, cockroaches, flies, mosquitoes, moths, silverfish, spiders and

wasps Date of registration: 5 January 2017 Product registration no.: 83847 Label approval no.: 83847/109071

Application no.: 109072 Product name: First Force Crawling Insect Killer High Performance Active constituent/s: 0.7 g/kg imiprothrin, 2 g/kg cypermethrin Applicant name: Aaron Laboratories Proprietary Limited Applicant ACN: 004 856 848 Summary of use For protection against crawling insects Date of registration: 5 January 2017 Product registration no.: 83848 Label approval no.: 83848/109072

Application no.: 102669 Product name: Avithor Bird Away Visual & Olfactory Bird Repellent Active constituent/s: 30 g/kg peppermint oil, 50 g/kg white pepper Applicant name: Ensystex Australasia Pty Ltd Applicant ACN: 102 221 965 Summary of use For repelling nuisance birds (including feral pigeons, starlings, barn swallows and common

mynas) in and around buildings Date of registration: 9 January 2017 Product registration no.: 81246 Label approval no.: 81246/102669



Application no.: 100114 Product name: Farmalinx Axyturf-M Fungicide Active constituent/s: 240 g/L metalaxyl-M Applicant name: Farmalinx Pty Ltd Applicant ACN: 134 353 245 Summary of use For the control of pythium in turf Date of registration: 9 January 2017 Product registration no.: 80045 Label approval no.: 80045/100114

Application no.: 107730 Product name: Yastar 330EC Herbicide Active constituent/s: 330 g/L pendimethalin Applicant name: Jiangsu Yongan Chemical Co., Ltd Applicant ACN: N/A Summary of use For the control of annual ryegrass and wireweed in wheat, barley and peas and annual

grasses and certain broadleaf weeds in various crops Date of registration: 10 January 2017 Product registration no.: 83209 Label approval no.: 83209/107730

Application no.: 108139 Product name: HomeGuard Total Termite Management System and Damp Proof Course Active constituent/s: 1 g/kg bifenthrin Applicant name: FMC Australasia Pty Ltd Applicant ACN: 095 326 891 Summary of use For the protection of structures from concealed termite entry Date of registration: 12 January 2017 Product registration no.: 83370 Label approval no.: 83370/108139

Application no.: 103787 Product name: Protect-Us Mineral Snail and Slug Killer Active constituent/s: 10 g/kg iron powder Applicant name: Ensystex Australasia Pty Ltd Applicant ACN: 102 221 965 Summary of use For the control of slugs and snails in agricultural and horticultural situations Date of registration: 13 January 2017 Product registration no.: 81712 Label approval no.: 81712/103787

Application no.: 105884 Product name: KDPC Mectin Insecticide/Miticide Active constituent/s: 18 g/L abamectin Applicant name: KD Plant Care Pty Ltd Applicant ACN: 134 592 804 Summary of use For the control of certain mites on apples, capsicums, citrus, cotton, hops, ornamentals, pears,

tomatoes and strawberries and native budworm on cotton Date of registration: 13 January 2017 Product registration no.: 82498 Label approval no.: 82498/105884



Application no.: 107303 Product name: Relyon Dimex 400EC Insecticide Active constituent/s: 400 g/L dimethoate (an anticholinesterase compound) Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of use For the control of a wide range of insect pests on fruit trees, certain vegetables, citrus, pastures,

cotton, lucerne, peanuts and ornamentals Date of registration: 16 January 2017 Product registration no.: 83009 Label approval no.: 83009/107303

2. VARIATIONS OF REGISTRATION

Application no: 108070 Product name: Huilong Propiconazole 250 EC Fungicide Active constituent/s: 250 g/L propiconazole Applicant name: Huilong Agrochemicals Australia Pty Ltd Applicant ACN: 165 921 031 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘AGSPRAY PROPICONAZOLE 250 EC FUNGICIDE’ to ‘HUILONG PROPICONAZOLE 250 EC FUNGICIDE’

Date of variation: 27 September 2016 Product registration no.: 66298 Label approval no.: 66298/108070

Application no: 107993 Product name: Huilong Abamectin Miticide/Insecticide Active constituent/s: 18 g/L abamectin Applicant name: Huilong Agrochemicals Australia Pty Ltd Applicant ACN: 165 921 031 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘AGSPRAY ABAMECTIN MITICIDE/INSECTICIDE’ to ‘HUILONG ABAMECTIN MITICIDE/INSECTICIDE’

Date of variation: 27 September 2016 Product registration no.: 60612 Label approval no.: 60612/107993

Application no: 107991 Product name: Huilong DSMA 500 Herbicide Active constituent/s: 500 g/L DSMA Applicant name: Huilong Agrochemicals Australia Pty Ltd Applicant ACN: 165 921 031 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘AGSPRAY DSMA 500 HERBICIDE’ to ‘HUILONG DSMA 500 HERBICIDE’ Date of variation: 27 September 2016 Product registration no.: 47559 Label approval no.: 47559/107991



Application no: 108245 Product name: Macro Protect Quizalofop 99.5EC Herbicide Active constituent/s: 99.5 g/L quizalofop-p-ethyl Applicant name: Macrofertil Australia Pty Ltd Applicant ACN: 166 370 976 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘RAVENSDOWN SANCTION 99.5EC HERBICIDE’ to ‘MACRO PROTECT QUIZALOFOP 99.5EC HERBICIDE’

Date of variation: 17 October 2016 Product registration no.: 58610 Label approval no.: 58610/108245

Application no: 108336 Product name: Apparent Affray 300 Herbicide Active constituent/s: 300 g/L 2,4-D Applicant name: Apparent Pty. Ltd Applicant ACN: 143 724 136 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘AGRICROP AFFRAY 300 HERBICIDE’ to ‘APPARENT AFFRAY 300 HERBICIDE’ Date of variation: 26 October 2016 Product registration no.: 56510 Label approval no.: 56510/108336

Application no: 104493 Product name: AC Fearsome 500 Fungicide Active constituent/s: 500 g/L flutriafol Applicant name: Axichem Pty Ltd Applicant ACN: 131 628 594 Summary of variation: To increase the application rate for use in wheat to control various diseases Date of variation: 4 January 2017 Product registration no.: 68744 Label approval no.: 68744/104493

Application no: 108092 Product name: Rifle 440 Herbicide Active constituent/s: 440 g/L pendimethalin Applicant name: Crop Care Australasia Pty Ltd Applicant ACN: 061 362 347 Summary of variation: To include a pack size range and update label Date of variation: 11 January 2017 Product registration no.: 54599 Label approval no.: 54599/108092

Application no: 107533 Product name: Magnathor Magnetic Insecticide with Magthanite Active constituent/s: 0.5 g/kg fipronil Applicant name: Ensystex Australasia Pty Ltd Applicant ACN: 102 221 965 Summary of variation: To extend use to include control of ants in urban situations and direct control of termites in nests

and other active workings Date of variation: 11 January 2017 Product registration no.: 66106 Label approval no.: 66106/107533



Application no: 106408 Product name: Ultraforce Crawling Insect Powder Active constituent/s: 5 g/kg fipronil Applicant name: Sherwood Chemicals Public Company Limited Applicant ACN: N/A Summary of variation: To change name from ‘ULTRAFORCE COCKROACH POWDER’ to ‘ULTRAFORCE CRAWLING

INSECT POWDER’ and to extend use to include internal and external control of nuisance ants in and around premises

Date of variation: 12 January 2017 Product registration no.: 80043 Label approval no.: 80043/106408

Application no: 106923 Product name: Roundup Ultra Max Herbicide Active constituent/s: 570 g/L glyphosate present as the potassium salt Applicant name: Monsanto Australia Ltd Applicant ACN: 006 725 560 Summary of variation: To add a new preharvest use in canola as a harvest aid and for weed control Date of variation: 12 January 2017 Product registration no.: 68506 Label approval no.: 68506/106923

Application no: 103469 Product name: Revus Fungicide Active constituent/s: 250 g/L mandipropamid Applicant name: Syngenta Australia Pty Ltd Applicant ACN: 002 933 717 Summary of variation: To extend use to include control of downy mildew of lettuce and leafy vegetables (including

brassica leafy vegetables) Date of variation: 9 January 2017 Product registration no.: 63052 Label approval no.: 63052/103469

3. LABEL APPROVAL

Application no.: 108392 Product name: Zenithor Gel Ant Bait Active constituent/s: 0.5 g/kg indoxacarb Applicant name: Ensystex Australasia Pty Ltd Applicant ACN: 102 221 965 Summary of use: To approve a new label for the product with the label name ‘PROTECT-US FORMEX GEL ANT BAIT’ Date of approval: 4 January 2017 Label approval no.: 81920/108392



4. VARIATION OF LABEL APPROVAL

Application no.: 107575 Product name: Brunnings Feed'n Weed Active constituent/s: 2.3 g/L dicamba present as the dimethylamine salt, 15 g/L MCPA present as the dimethylamine salt Applicant name: Brunnings Garden Products Pty Ltd Applicant ACN: 050 655 760 Summary of variation: To change the label particulars to amend the how to use section and other minor changes Date of variation: 9 January 2017 Label approval no.: 60968/107575

Application no: 107576 Product name: Brunnings Bindii Kill For Lawns Active constituent/s: 2.3 g/L dicamba present as the dimethylamine salt, 15 g/L MCPA present as the dimethylamine

salt Applicant name: Brunnings Garden Products Pty Ltd Applicant ACN: 050 655 760 Summary of variation: To vary label approval to amend label statements Date of variation: 10 January 2017 Product registration no.: 63036 Label approval no.: 63036/107576



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 NEW ACTIVE CONSTITUENTS

Application no.: 62085 Product name: Osurnia Ear Gel For Dogs Active constituent/s: 10 mg/1.2 g tube terbinafine, 10 mg/1.2 g tube florfenicol, 1 mg/1.2 g tube betamethasone

acetate Applicant name: Elanco Australasia Pty Ltd Applicant ACN: 076 745 198 Summary of use For the treatment of acute otitis externa and acute exacerbation of recurrent otitis externa Date of registration/approval: 16 December 2016 Product registration no.: 69931 Label approval no.: 69931/62085

Application no.: 101991 Product name: SIMPARICA Chews For Dogs 1.3–2.5KG Active constituent/s: 5 mg/tablet sarolaner Applicant name: Zoetis Australia Pty Ltd Applicant ACN: 156 476 425 Summary of use For the treatment and prevention of flea infestations and the treatment and control of ticks

on dogs and puppies. Also for the treatment and control of ear mites, demodex mites, and sarcoptic mange

Date of registration/approval: 22 December 2016 Product registration no.: 80951 Label approval no.: 80951/101991

Application no.: 101990 Product name: SIMPARICA Chews For Dogs 2.6–5 KG Active constituent/s: 10 mg/tablet sarolaner Applicant name: Zoetis Australia Pty Ltd Applicant ACN: 156 476 425 Summary of use For the treatment and prevention of flea infestations and the treatment and control of ticks











Application no.: 101984 Product name: SIMPARICA Chews For Dogs 20.1–40 KG

Active constituent/s: 80 mg/tablet sarolaner Applicant name: Zoetis Australia Pty Ltd Applicant ACN: 156 476 425 Summary of use For the treatment and prevention of flea infestations and the treatment and control of ticks



Application no.: 101980 Product name: SIMPARICA Chews For Dogs 40.1–60KG Active constituent/s: 120 mg/tablet sarolaner Applicant name: Zoetis Australia Pty Ltd Applicant ACN: 156 476 425 Summary of use For the treatment and prevention of flea infestations and the treatment and control of ticks





2. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Application no.: 104815 Product name: Gonadiol Active constituent/s: 1 mg/mL oestradiol benzoate Applicant name: Boehringer Ingelheim Pty Limited, Vetmedica Division Applicant ACN: 000 452 308 Summary of use For use in oestrus synchronization programmes in cycling cattle and for use in the

treatment of anoestrus cattle Date of registration: 23 December 2016 Product registration no.: 82023 Label approval no.: 82023/104815

Application no.: 62810 Product name: Temedip Sheep Dip Active constituent/s: 350 g/L temephos (an anticholinesterase compound) Applicant name: The Hunter River Company Pty Limited Applicant ACN: 133 798 615 Summary of use For use in the control of body lice on wet and dry short wool sheep by plunge or shower

dipping Date of registration: 23 December 2016 Product registration no.: 70244 Label approval no.: 70244/62810

Application no.: 104481 Product name: Zamichlor Soluble Active constituent/s: 950 g/kg chlortetracycline hydrochloride Applicant name: Zamira Life Sciences Pty Ltd Applicant ACN: 130 641 502 Summary of use For the control or treatment of diseases of poultry and pigs caused by micro-organisms

sensitive to chlortetracycline Date of registration: 23 December 2016 Product registration no.: 81953 Label approval no.: 81953/104481

Application no.: 105340 Product name: Zeromec Soluble Wormer For Pigs Active constituent/s: 10 g/L ivermectin Applicant name: Abbey Laboratories Pty Ltd Applicant ACN: 156 000 430 Summary of use For the treatment and control of gastrointestinal; roundworms, kidney worms and

lungworms in pigs Date of registration: 10 January 2017 Product registration no.: 82271 Label approval no.: 82271/105340



Application no.: 105369 Product name: Zeromec SC Oral Concentrate Parasiticide for Sheep Active constituent/s: 10 g/L ivermectin Applicant name: Abbey Laboratories Pty Ltd Applicant ACN: 156 000 430 Summary of use For use in the treatment of internal parasites and control of internal parasites, nasal bot

and itch mite of sheep Date of registration: 10 January 2017 Product registration no.: 82287 Label approval no.: 82287/105369

Application no.: 107644 Product name: Cyclashield Spray-On Sheep Blowfly Treatment Active constituent/s: 50 g/L dicyclanil Applicant name: The Hunter River Company Pty Limited Applicant ACN: 133 798 615 Summary of use For the protection of sheep against fly strike Date of registration: 12 January 2017 Product registration no.: 83154 Label approval no.: 83154/107644

Application no.: 105263 Product name: Porcilis PCV M HYO Active constituent/s: Each dose of 2 mL contains:

Porcine circovirus type 2 (PCV2) ORF 2 subunit antigen: ≥ 2828 AU 1 mycoplasma hyopneumoniae J strain inactivated: ≥ 2.69 RPU 2

Applicant name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of use For the active immunisation of pigs for the reduction of PCV2 viraemia and virus shedding,

and as an aid in the prevention of enzootic pneumonia caused by mycoplasma hyopneumoniae

Date of registration: 13 January 2017 Product registration no.: 82241 Label approval no.: 82241/105263

3. VARIATIONS OF REGISTRATION

Application no: 108227 Product name: Exelpet Vet Series Monthly Flea, Intestinal & Heartworm Treatment For Dogs 10–25 KG Active constituent/s: 100 g/L imidacloprid, 25 g/L moxidectin Applicant name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘VETS CHOICE FOR DOGS 10–25 KG FLEAS, HEARTWORM AND WORMS’ to ‘EXELPET VET SERIES MONTHLY FLEA, INTESTINAL & HEARTWORM TREATMENT FOR DOGS 10–25 KG’




Application no: 108226 Product name: Exelpet Vet Series Monthly Flea, Intestinal & Heartworm Treatment For Dogs Over 25 kg Active constituent/s: 100 g/L imidacloprid 25 g/L moxidectin Applicant name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘VETS CHOICE FOR DOGS OVER 25 KG FLEAS, HEARTWORM AND WORMS’ to ‘EXELPET VET SERIES MONTHLY FLEA, INTESTINAL & HEARTWORM TREATMENT FOR DOGS OVER 25 KG’


Application no: 108231 Product name: Exelpet Vet Series Monthly Flea, Intestinal & Heartworm Treatment For Kittens & Small Cats

Up To 4 kg Active constituent/s: 100 g/L imidacloprid 10 g/L moxidectin Applicant name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘VETS CHOICE FOR KITTENS AND SMALL CATS UP TO 4 KG FLEAS, HEARTWORM AND WORMS’ to ‘EXELPET VET SERIES MONTHLY FLEA, INTESTINAL & HEARTWORM TREATMENT FOR KITTENS & SMALL CATS UP TO 4 KG’


Application no: 108243 Product name: Exelpet Vet Series Spot-On All-Wormer For Cats 2.5–5kg Active constituent/s: 21.4 g/L emodepside, 85.8 g/L praziquantel Applicant name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘VETS CHOICE FOR CATS 2.5KG TO 5KG ALLWORMER SPOT-ON’ to ‘EXELPET VET SERIES SPOT-ON ALL-WORMER FOR CATS 2.5–5 KG’


Application no: 108232 Product name: Exelpet Vet Series Spot-On All-Wormer For Cats 5–8 kg Active constituent/s: 21.4 g/L emodepside, 85.8 g/L praziquantel Applicant name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘VETS CHOICE FOR CATS 5 KG TO 8 KG ALLWORMER SPOT-ON’ to ‘EXELPET VET SERIES SPOT-ON ALL-WORMER FOR CATS 5–8 KG’




Application no: 108757 Product name: Zeromec Premix For Pigs Active constituent/s: 6 g/kg ivermectin Applicant name: Abbey Laboratories Pty Ltd Applicant ACN: 156 000 430 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘NOROMECTIN PREMIX FOR PIGS’ to ‘ZEROMEC PREMIX FOR PIGS’ Date of variation: 29 November 2016 Product registration no.: 55455 Label approval no.: 55455/108757



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 CONSITUTENT

Application no.: 101303 Active constituent/s: Fluopicolide Applicant name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of use: For use in agricultural chemical products Date of approval: 22 December 2016 Approval no.: 80628

Application no.: 105788 Active constituent/s: Terbinafine Applicant name: Elanco Australasia Pty Ltd Applicant ACN: 076 745 198 Summary of use: For use in veterinary chemical products Date of approval: 15 December 2016 Approval no.: 82455

Application no.: 106703 Active constituent/s: Triclopyr butoxyethyl ester Applicant name: Foison Scitech Co., Ltd Applicant ACN: N/A Summary of use: For use in agricultural chemical products Date of approval: 3 January 2017 Approval no.: 82760

Application no.: 106688 Active constituent/s: Metaldehyde Applicant name: Jiangsu Good Harvest-Weien Agrochemical Co Ltd Applicant ACN: N/A Summary of use: For use in agricultural chemical products Date of approval: 3 January 2017 Approval no.: 82757

Application no.: 106742 Active constituent/s: Iprodione Applicant name: Foison Scitech Co., Limited Applicant ACN: N/A Summary of use: For use in agricultural chemical products Date of approval: 6 January 2017 Approval no.: 82783



Application no.: 105294 Active constituent/s: Ipconazole Applicant name: Arysta Lifescience Australia Pty Ltd Applicant ACN: 005 225 507 Summary of use: For use in agricultural chemical products Date of approval: 9 January 2017 Approval no.: 82255

2. VARIATIONS OF ACTIVE CONSTITUENT

Application no.: 105098 Active constituent/s: Zinc pyrithione Applicant name: Lonza Cologne GMBH Applicant ACN: N/A Summary of variation: Variation of relevant particulars or conditions of an approved active constituent Date of variation: 11 January 2017 Approval no.: 44545



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

The APVMA has issued the following licences under subsection 123(1) of the Agricultural and Veterinary Chemicals Code [the Agvet Code]

MCKINNON DIRECT PACKAGING AND FULFILMENT PTY LTD

LICENCE NO: 6207

ACN: 068 259 496

Unit A

2 Hudson Avenue

CASTLE HILL NSW 2154

Product Types:*

• Category 6: Single step manufacture

Step(s) of Manufacture: secondary packaging and secondary/supplementary labelling

Licence Issued: 2 December 2016

2. CHANGES TO EXISTING LICENCES

The APVMA has issued the following licences under subsection 123(1) of the Agricultural and Veterinary Chemicals Code [the Agvet Code

SILLIKER AUSTRALIA PTY. LTD.

LICENCE NO: 6006

ACN: 006 462 335

18–20 King Street

BLACKBURN VIC 3130

Product Types: *

• Category 6: Single step manufacture

Step(s) of Manufacture: Analysis and testing (Microbiological and sterility test)

Amended Licence Issued: 7 December 2016


http://www.apvma.gov.au/


KATO LABORATORIES PTY. LTD.

LICENCE NO: 2119

ACN: 000 397 240

61 Chivers Road

SOMERSBY NSW 2250

Product Types: *

• Category 2: Tablets, creams/lotion, ointments, pastes, powders and liquids.

Step(s) of Manufacture: Quality Assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, strip, blister or sachet packaging, dry milling, microencapsulation, granulation, tableting, tablet coating, analysis and testing (physical), storage and release for supply.


SYPHARMA PTY. LTD. LICENCE NO: 1082

ACN: 114 895 064

27 Healey Road

DANDENONG VIC 3175

Product Types: *

• Category 1: Sterile products

• Category 2: Creams/lotions, ointments, pastes, powders, liquids and suspensions

• Category 3: Liquids

• Category 4: Premixes and supplements

Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, aseptic filling, packaging, labelling, microbiological reduction treatment (filtration and heat), sterilisation (heat and filtration), analysis and testing (physical, chemical, microbiological, immunobiological, Limulus Amoebocyte Lysate [LAL] test and sterility testing), storage and release for supply.


3. LICENCE CANCELLATIONS

The APVMA has cancelled the following licences under subsection 127(1) of the Agricultural and Veterinary Chemicals Code [the Agvet Code].

Nil

4. LICENCE SUSPENSIONS

The APVMA has suspended the following licences under subsection 127(1) of the Agricultural and Veterinary Chemicals Code [the Agvet Code].

Nil



5. 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].

Nil

6. REVOCATION OF LICENCE SUSPENSION

The APVMA has revoked the suspension of the following licences under subsection 127(7) of the Agricultural and Veterinary Chemicals Code [the Agvet Code].

Nil

APVMA CONTACT

Manufacturing Quality and Licensing Section

Legal and Compliance Program

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4899

Fax: +61 2 6210 4813

Email: [email protected]


mailto:[email protected]

apvma gazette no. 2, 24 january 2017. apvma 2, tuesday, 24 january 2017 agricultural and veterinary...

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