APVMA Gazette No. 23, 19 November 2013Nov 19, 2013 · Product Name: Timtech Azguard HF LOSP Wood...
Transcript of APVMA Gazette No. 23, 19 November 2013Nov 19, 2013 · Product Name: Timtech Azguard HF LOSP Wood...
No. APVMA 23, Tuesday, 19 November 2013
Published by The Australian Pesticides & Veterinary Medicines Authority
AGRICULTURAL AND
VETERINARY CHEMICALS
The Agricultural and Veterinary Chemical Code Act 1994 (the Act) commenced on 15 March 1995.
The Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Act requires notices to be
published in the Gazette containing details of the registration of agricultural and veterinary chemical products
and other approvals granted by the Australian Pesticides and Veterinary Medicines Authority. The Agvet Code
and related legislation also requires certain other notices to be published in the Gazette. A reference to Agvet
Codes in this publication is a reference to the Agvet Code in each state and territory jurisdiction.
ISSN 1837 – 7629
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 2
Commonwealth of Australia 2013
This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any
process without prior written permission from the Australian Pesticides and Veterinary Medicines Authority. Requests and
inquiries concerning reproduction and rights should be addressed to:
The Manager, Public Affairs and Communications
The Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604
Email: [email protected]
Website: www.apvma.gov.au.
GENERAL INFORMATION
The APVMA (Australian Pesticides and Veterinary Medicines Authority) Gazette is published fortnightly and contains details of
the registration of agricultural and veterinary chemicals products and other approvals granted by the APVMA, notices as requi red
by the Agricultural and Veterinary Chemicals Code (the Agvet Code) and related legislation and a range of regulatory material
issued by the APVMA.
Pursuant to section 53(1) of the Agvet Code, the APVMA has decided that it is unnecessary to publish details of applications
made for the purpose of notifying minor variations to registration details. The APVMA will however report notifications activity in
quarterly statistical reports.
DISTRIBUTION AND SUBSCRIPTION
The APVMA Gazette is published in electronic format only and is available from the APVMA website,
www.apvma.gov.au/publications/gazette/.
If you would like to receive email notification when a new edition is published, please subscribe on the APVMA website.
APVMA CONTACTS
For enquiries regarding the publishing and distribution of the APVMA Gazette: Telephone: +61 2 6210 4870
For enquiries on the APVMA Gazette content, please refer to the individual APVMA contacts listed under each notice.
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 3
CONTENTS
Notice of Registrations 4 Agricultural Chemical Products .............................................................................................................................................. 4 Veterinary Chemical Products .............................................................................................................................................. 12
Other Notices 15 Licensing of Veterinary Chemical Manufacturers ................................................................................................................. 15 Addendum to the Record of Approved Active Constituents .................................................................................................. 20
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 4
Notice of Registrations – Agricultural Chemical Products
NOTICE OF REGISTRATIONS
Agricultural Chemical Products
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals
Code Act 1994, the APVMA hereby gives notice that it has registered or varied the registration in respect of the following
products, with effect from the dates shown.
1. RESTRICTED PRODUCT
Product Name: Termigreen Termite Barrier
Active Constituent/s: 5.2 g/kg bifenthrin
Applicant Name: The White Ant Co. Pty. Ltd.
Applicant ACN: 100 706 009
Summary of Use: For use as a termite-resistant physical barrier in buildings for the protection of structures from concealed termite entry
Date of Registration: 4 November 2013
Label Approval No: 69236/60324
Product Name: 4Farmers 1080 Impregnated Oats (Fox Control)
Active Constituent/s: 3 mg sodium fluoroacetate (1080) per oat
Applicant Name: 4Farmers Australia Pty Ltd
Applicant ACN: 160 092 428
Summary of Use: For the control of foxes
Date of Registration: 6 November 2013
Label Approval No: 68726/58962
2. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Product Name: Ecomist Enhancing Your Environment Insect Sniper Residual Surface Spray
Active Constituent/s: 2 g/kg cyphenothrin, 2 g/kg d-tetramethrin
Applicant Name: Damar Industries Pty Limited
Applicant ACN: 097 723 610
Summary of Use: For knockdown and residual control of household insects such as ants, carpet beetles, cockroaches, fleas, flies, millipedes, mosquitoes, adult moth & moth larvae, silverfish, slaters, spiders & wasps. Effective control of cockroaches & other crawling insects for up to 3 months
Date of Registration: 15 October 2013
Label Approval No: 69306/60449
Product Name: Vantal Upgrade Insecticide/Miticide
Active Constituent/s: 36 g/L abamectin
Applicant Name: Ospray Pty Ltd
Applicant ACN: 110 199 169
Summary of Use: For the control of certain mite and insect pests in various fruit and vegetable crops, cotton, hops and ornamentals
Date of Registration: 23 October 2013
Label Approval No: 67524/56279
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 5
Notice of Registrations – Agricultural Chemical Products
Product Name: Ilium Cephalexin 600 For Dogs
Active Constituent/s: Each tablet contains 600 mg cephalexin (as cephalexin monohydrate)
Applicant Name: Troy Laboratories Pty Ltd
Applicant ACN: 000 283 769
Summary of Use: For the treatment of bacterial infections of the skin, soft tissue, joint respiratory tract and urinary tract of dogs
Date of Registration: 25 October 2013
Label Approval No: 67796/56888
Product Name: Brumby 480 SC Fungicide
Active Constituent/s: 480 g/L prothioconazole
Applicant Name: Bayer CropScience Pty Ltd
Applicant ACN: 000 226 022
Summary of Use: For control of leaf diseases in peanuts
Date of Registration: 30 October 2013
Label Approval No: 68332/58132
Product Name: Tops Plant Growth Regulator
Active Constituent/s: 100 g/kg triclopyr
Applicant Name: Agriphar S.A.
Applicant ACN: N/A
Summary of Use: For thinning and increasing fruit size in oranges and mandarins and for reducing fruit drop in lychees
Date of Registration: 5 November 2013
Label Approval No: 66481/53736
Product Name: Kenso Agcare Gundy 240 Herbicide
Active Constituent/s: 240 g/L imazapic present as the ammonium salt
Applicant Name: Kenso Corporation (M) Sdn. Bhd.
Applicant ACN: N/A
Summary of Use: For the pre-emergence control of certain annual grass and broadleaf weeds in fallow
situations and sugarcane
Date of Registration: 5 November 2013
Label Approval No: 67108/55225
Product Name: Sinochem Intersect 200SC Insecticide
Active Constituent/s: 200 g/L imidacloprid
Applicant Name: Sinochem Agro Co., Ltd
Applicant ACN: N/A
Summary of Use: For the control of various insect pests of cotton, fruit, vegetables and ornamentals
Date of Registration: 6 November 2013
Label Approval No: 68892/59319
Product Name: Nufarm Weedmaster Argo Dual Salt Technology Herbicide
Active Constituent/s: 540 g/L glyphosate (present as the potassium and isopropylamine salts)
Applicant Name: Nufarm Australia Limited
Applicant ACN: 004 377 780
Summary of Use: For use as a non-selective herbicide for the control of various annual and perennial weeds
Date of Registration: 7 November 2013
Label Approval No: 68925/59392
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 6
Notice of Registrations – Agricultural Chemical Products
Product Name: Farmalinx Bazooka 800 SG Herbicide
Active Constituent/s: 800 g/kg glyphosate (present as the acid and ammonium salt)
Applicant Name: Farmalinx Pty Ltd
Applicant ACN: 134 353 245
Summary of Use: For control of annual and perennial weeds in a range of agricultural and non-agricultural situations
Date of Registration: 8 November 2013
Label Approval No: 69121/60015
Product Name: TimTech Azguard LOSP Wood Preservative Concentrate
Active Constituent/s: 16 g/L permethrin, 22.5 g/L propiconazole, 22.5 g/L tebuconazole
Applicant Name: TimTech Chemicals Pty Ltd
Applicant ACN: 096 245 108
Summary of Use: For the protection of softwood timber to be used for hazard level 3 situations (outside and above ground) against fungal decay and timber insects, such as borers and termites
Date of Registration: 8 November 2013
Label Approval No: 66270/58806
Product Name: Bard High Performance Surface Spray
Active Constituent/s: 0.7 g/kg imiprothrin, 2 g/kg cypermethrin
Applicant Name: Barr Glebe Group Pty Ltd
Applicant ACN: 119 998 435
Summary of Use: For use in domestic situations for control of crawling insects
Date of Registration: 8 November 2013
Label Approval No: 69482/60913
Product Name: Searles Trifend Complete Garden Spray
Active Constituent/s: 0.1 g/L tau-fluvalinate, 0.05 g/L myclobutanil
Applicant Name: J C & A T Searle Pty Ltd
Applicant ACN: 002 898 893
Summary of Use: For control of insects on plants in the home garden
Date of Registration: 8 November 2013
Label Approval No: 69363/60593
Product Name: Advion Fire Ant Bait
Active Constituent/s: 0.45 g/kg indoxacarb
Applicant Name: Du Pont (Australia) Pty Ltd
Applicant ACN: 000 716 469
Summary of Use: For the control of fire ants in a range of urban and agricultural situations
Date of Registration: 8 November 2013
Label Approval No: 66532/53830
Product Name: Apparent Propiconazole 250 EC Fungicide
Active Constituent/s: 250 g/L propiconazole
Applicant Name: Apparent Pty. Ltd.
Applicant ACN: 143 724 136
Summary of Use: For the control of certain fungal diseases of bananas, oats, peanuts, perennial ryegrass, pineapples, stone fruit, sugarcane, wheat and other crops
Date of Registration: 11 November 2013
Label Approval No: 69469/60895
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 7
Notice of Registrations – Agricultural Chemical Products
Product Name: Apparent Dicamba 700 Herbicide
Active Constituent/s: 700 g/kg dicamba present as the sodium salt
Applicant Name: Apparent Pty. Ltd.
Applicant ACN: 143 724 136
Summary of Use: For the control of certain broadleaf weeds in winter cereals, pastures, conservation tillage, sugarcane, rice, turf, grain sorghum and non-crop areas
Date of Registration: 11 November 2013
Label Approval No: 69471/60899
Product Name: Timtech Azguard HF LOSP Wood Preservative Concentrate
Active Constituent/s: 16 g/L permethrin, 22.5 g/L propiconazole, 22.5 g/L tebuconazole
Applicant Name: TimTech Chemicals Pty Ltd
Applicant ACN: 096 245 108
Summary of Use: For the protection of softwood timber to be used for hazard level H3 (outside and above ground) situations against fungal decay and timber insects, including lyctids, borers and termites
Date of Registration: 11 November 2013
Label Approval No: 68590/58650
Product Name: FMC Imazapic 240 Herbicide
Active Constituent/s: 240 g/L imazapic present as the ammonium salt
Applicant Name: FMC Australasia Pty Ltd
Applicant ACN: 095 326 891
Summary of Use: For the pre-emergence control of certain annual grass and broadleaf weeds in fallow situations, sugarcane and peanuts and early post-emergence control of certain annual grass and broadleaf weeds in peanuts and sugarcane
Date of Registration: 11 November 2013
Label Approval No: 69495/60935
Product Name: Fascinate 200 SL Herbicide
Active Constituent/s: 200 g/L glufosinate-ammonium
Applicant Name: United Phosphorus Ltd.
Applicant ACN: 066 391 384
Summary of Use: For use in various situations for non-residual control of broadleaf and grass weeds
Date of Registration: 11 November 2013
Label Approval No: 69545/61093
Product Name: AC Epoch 125 SC Fungicide
Active Constituent/s: 125 g/L epoxiconazole
Applicant Name: Axichem Pty Ltd
Applicant ACN: 131 628 594
Summary of Use: For the control of leaf rust, stripe rust and septoria nodorum blotch in wheat and leaf rust in barley
Date of Registration: 11 November 2013
Label Approval No: 69445/60811
Product Name: Enviromax Bromoxynil-MCPA Selective Herbicide
Active Constituent/s: 200 g/L bromoxynil as the octanoate, 200 g/L MCPA as the ethyl hexyl ester
Applicant Name: Enviromax Technologies Pty Ltd
Applicant ACN: 132 643 577
Summary of Use: For use in the control of weeds in wheat, oats, barley, cereal rye, triticale, l inseed, grass pastures and turf
Date of Registration: 12 November 2013
Label Approval No: 69397/60674
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 8
Notice of Registrations – Agricultural Chemical Products
Product Name: Kenso Agcare Bifenthrin Termiticide & Insecticide
Active Constituent/s: 100 g/L bifenthrin
Applicant Name: Kenso Corporation (M) Sdn Bhd
Applicant ACN: N/A
Summary of Use: For the protection of structures from subterranean termite damage, control of termites, other urban pests and various insect and mite pests in a variety of crops, including turf
Date of Registration: 12 November 2013
Label Approval No: 69277/60398
Product Name: Resource Gardening Rose Spray Insect Killer Ready To Use
Active Constituent/s: 0.1 g/L tau-fluvalinate, 0.05 g/L myclobutanil
Applicant Name: Amgrow Pty Ltd
Applicant ACN: 100 684 786
Summary of Use: For the control of various insects and fungal diseases on roses and ornamentals
Date of Registration: 12 November 2013
Label Approval No: 69376/60633
Product Name: Kenso Agcare Methomyl 225 Insecticide
Active Constituent/s: 225 g/L methomyl (an anti-cholinesterase compound)
Applicant Name: Kenso Corporation (M) Sdn. Bhd.
Applicant ACN: N/A
Summary of Use: For the control of insect pests in various crops
Date of Registration: 12 November 2013
Label Approval No: 69507/60956
Product Name: Agro-Gold Bifenthrin 2 Granule Insecticide
Active Constituent/s: 2 g/kg bifenthrin
Applicant Name: Agro-Alliance (Australia) Pty Ltd
Applicant ACN: 130 864 603
Summary of Use: For the control of certain pests in turf and ants, fleas and ticks in external surrounds of buildings and structures
Date of Registration: 13 November 2013
Label Approval No: 69435/60791
Product Name: Santalum Mosquito Repellent Incense Coils
Active Constituent/s: 15 g/kg citronella oil, 15 g/kg eucalyptus oil
Applicant Name: Mayo Hardware Pty Ltd
Applicant ACN: 071 517 176
Summary of Use: For repelling mosquitoes in outdoor domestic situations
Date of Registration: 13 November 2013
Label Approval No: 69451/60819
Product Name: Bard Fly And Insect Spray
Active Constituent/s: 6.36 g/kg N-octyl bicycloheptene dicarboximide, 4.34 g/kg piperonyl butoxide, 0.50 g/kg phenothrin 20:80, 2.16 g/kg tetramethrin 20:80
Applicant Name: Barr Glebe Group Pty Ltd
Applicant ACN: 119 998 435
Summary of Use: For household protection against flying insects
Date of Registration: 13 November 2013
Label Approval No: 69481/60912
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 9
Notice of Registrations – Agricultural Chemical Products
Product Name: IcON Phite 400 Systemic Fungicide
Active Constituent/s: 400 g/L phosphorous (phosphonic) acid present as mono (and) di potassium phosphite
Applicant Name: Sonic Essentials Pty Ltd
Applicant ACN: 127 016 406
Summary of Use: For the control of root rot in avocado and subterranean clover, root and collar rot in citrus, root and crown rot in ornamentals & root and heart rot in pineapples caused by phytophthora fungi and for the control of downy mildew in grapes
Date of Registration: 13 November 2013
Label Approval No: 69516/60992
Product Name: Amgrow Organosilicone Surfactant
Active Constituent/s: 1020 g/L polyether modified polysiloxane
Applicant Name: Amgrow Pty Ltd
Applicant ACN: 100 684 786
Summary of Use: For improved coverage, penetration and uptake of herbicides, fungicides, insecticides, miticides and foliar micro-nutrients
Date of Registration: 13 November 2013
Label Approval No: 69429/60773
Product Name: Agro-Gold Permethrin Insecticidal Dust
Active Constituent/s: 10 g/kg permethrin 25:75
Applicant Name: Agro-Alliance (Australia) Pty Ltd
Applicant ACN: 130 864 603
Summary of Use: For use as a ready to use dust treatment for the control of cockroaches, ants, fleas, silverfish, bedbugs, mushroom flies, potato moths, hide beetles and European Wasps
Date of Registration: 13 November 2013
Label Approval No: 69436/60792
Product Name: Apparent Imidacloprid 350 SC Insecticide
Active Constituent/s: 350 g/L imidacloprid
Applicant Name: Apparent Pty. Ltd.
Applicant ACN: 143 724 136
Summary of Use: For the control of Greyback and Childers canegrub in sugarcane and Silverleaf whitefly i n various vegetable crops
Date of Registration: 13 November 2013
Label Approval No: 69499/60944
Product Name: Sabakem Diclofop 375EC Selective Herbicide
Active Constituent/s: 375 g/L diclofop-methyl
Applicant Name: Sabakem Pty Ltd
Applicant ACN: 151 682 138
Summary of Use: For the post-emergent control of annual ryegrass, common barbgrass and wild oats in wheat, linseed, peas, turf and other crops
Date of Registration: 13 November 2013
Label Approval No: 69246/60336
Product Name: Avon Skin-So-Soft SSS Bug Guard Plus Picaridin Insect Repellent Aerosol With Vitamin E
Active Constituent/s: 97 g/kg picaridin
Applicant Name: Avon Products Pty Limited
Applicant ACN: 008 428 457
Summary of Use: For use as a personal insect repellent
Date of Registration: 13 November 2013
Label Approval No: 68813/59141
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 10
Notice of Registrations – Agricultural Chemical Products
Product Name: AC Caprice 570 EC Selective Herbicide
Active Constituent/s: 570 g/L MCPA present as the 2-ethyl hexyl ester
Applicant Name: Axichem Pty Ltd
Applicant ACN: 131 628 594
Summary of Use: For use in various agricultural crops
Date of Registration: 13 November 2013
Label Approval No: 69443/60809
Product Name: No Bugs Concentrate Insecticide
Active Constituent/s: 10 g/L deltamethrin
Applicant Name: Aussiecare Corporation Pty Limited
Applicant ACN: 051 456 038
Summary of Use: For the control of mosquitoes, houseflies and a range of other pest insects and mites in domestic, commercial, industrial and public buildings
Date of Registration: 14 November 2013
Label Approval No: 63358/45432
3. VARIATIONS
Product Name: Turf Culture Embargo Herbicide
Applicant Name: Turf Culture Pty Ltd
Applicant ACN: 117 986 615
Summary of Variation: To extend the use to include Queensland Blue Couch and for the suppression of Parramatta Grass and update the label
Date of Variation: 5 November 2013
Label Approval No: 65075/59274
Product Name: Transform Insecticide
Applicant Name: Dow AgroSciences Australia Limited
Applicant ACN: 003 771 659
Summary of Variation: To update the Relevant Label Particulars to include an additional statement ‘Do not use in covered or protected situations such as glass houses, green houses, shade houses or plastic tunnels’ as requested by the APVMA
Date of Variation: 6 November 2013
Label Approval No: 64101/61099
Product Name: Elanco AH0495 Elector PSP Animal Premise Spray
Applicant Name: Elanco Animal Health A Div Of Eli Lilly Aust Pty Ltd
Applicant ACN: 000 233 992
Summary of Variation: To amend spray application instructions by removing advice to use a ‘coarse, low pressure’ spray
Date of Variation: 7 November 2013
Label Approval No: 59422/61040
Product Name: LuciTrap Sheep Blowfly Attractant
Applicant Name: Insect Management Services Pty Ltd
Applicant ACN: 162 387 751
Summary of Variation: To change the product name from ‘LUCILURE SHEEP BLOWFLY ATTRACTANT’ to ‘LUCITRAP SHEEP BLOWFLY ATTRACTANT’, and update the Relevant Label Particulars
Date of Variation: 7 November 2013
Label Approval No: 51198/60728
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 11
Notice of Registrations – Agricultural Chemical Products
Product Name: Nufarm Weedmaster DST Dual Salt Technology Herbicide
Applicant Name: Nufarm Australia Limited
Applicant ACN: 004 377 780
Summary of Variation: To change the product name from ‘NUFARM WEEDMASTER DUAL SALT TECHNOLOGY HERBICIDE’ to ‘NUFARM WEEDMASTER DST DUAL SALT TECHNOLOGY HERBICIDE’ and to update to the Relevant Label Particulars
Date of Variation: 12 November 2013
Label Approval No: 62723/60498
Product Name: Hammer 400EC Herbicide
Applicant Name: FMC Australasia Pty Ltd
Applicant ACN: 095 326 891
Summary of Variation: To reduce the withholding period for pasture to nil
Date of Variation: 13 November 2013
Label Approval No: 63228/51559
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 12
Notice of Registrations – Veterinary Chemical Products
Veterinary Chemical Products
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals
Code Act 1994, the APVMA hereby gives notice that it has registered or varied the registration in respect of the following
products, with effect from the dates shown.
1. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Product Name: Optiphos 10000 Microgranulate
Active Constituent/s: 6-phytase (I.U.B. 3.1.3.26): min 10000 FTU/g
Applicant Name: Huvepharma AD
Applicant ACN: N/A
Summary of Use: For use in pigs and poultry to improve the digestibility of feed
Date of Registration: 5 November 2013
Label Approval No: 66424/53612
Product Name: Optiphos 5000 Microgranulate
Active Constituent/s: 6-phytase (I.U.B. 3.1.3.26): min 5000 FTU/g
Applicant Name: Huvepharma AD
Applicant ACN: N/A
Summary of Use: For use in pigs and poultry to improve the digestibility of feed
Date of Registration: 5 November 2013
Label Approval No: 66558/53865
Product Name: Optiphos 10000 Coated
Active Constituent/s: 6-phytase (I.U.B. 3.1.3.26): min 10000 FTU/g
Applicant Name: Huvepharma AD
Applicant ACN: N/A
Summary of Use: For use in pigs and poultry to improve the digestibility of feed
Date of Registration: 5 November 2013
Label Approval No: 66425/53613
Product Name: Optiphos 5000 Coated
Active Constituent/s: 6-phytase (I.U.B. 3.1.3.26): min 5000 FTU/g
Applicant Name: Huvepharma AD
Applicant ACN: N/A
Summary of Use: For use in pigs and poultry to improve the digestibility of feed
Date of Registration: 5 November 2013
Label Approval No: 66557/53864
Product Name: Optiphos 5000 Liquid
Active Constituent/s: 6-phytase (I.U.B. 3.1.3.26): min 5000 FTU/g
Applicant Name: Huvepharma AD
Applicant ACN: N/A
Summary of Use: For use in pigs to improve digestibility of feed
Date of Registration: 5 November 2013
Label Approval No: 66556/53863
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 13
Notice of Registrations – Veterinary Chemical Products
Product Name: Optiphos 20000 Liquid
Active Constituent/s: 6-phytase (I.U.B. 3.1.3.26): min 20000 FTU/ml
Applicant Name: Huvepharma AD
Applicant ACN: N/A
Summary of Use: For use in pigs to improve digestibility of feed
Date of Registration: 5 November 2013
Label Approval No: 66426/53614
Product Name: Optiphos 10000 Liquid
Active Constituent/s: 6-phytase (I.U.B. 3.1.3.26): min 10000 FTU/mL
Applicant Name: Huvepharma AD
Applicant ACN: N/A
Summary of Use: For use in pigs to improve the digestibility of feed
Date of Registration: 5 November 2013
Label Approval No: 66555/53862
Product Name: Activyl Spot-On for Extra Large Dogs over 40 kg up to 60 kg
Active Constituent/s: 195 g/L indoxacarb (s-isomer)
Applicant Name: Intervet Australia Pty Limited
Applicant ACN: 008 467 034
Summary of Use: For the control of existing flea infestations and new flea infestations as well as flea allergy dermatitis on dogs
Date of Registration: 6 November 2013
Label Approval No: 64438/48354
Product Name: Vetsense Kilverm Poultry Wormer
Active Constituent/s: 14 g/L levamisole (equivalent to 16.5 g/L levamisole hydrochloride)
Applicant Name: Vetsense Pty Ltd
Applicant ACN: 150 968 871
Summary of Use: For use in treatment of sensitive strains of roundworms in poultry
Date of Registration: 6 November 2013
Label Approval No: 68060/57408
Product Name: Purevet Meloxicam Oral Suspension For Dogs
Active Constituent/s: 1.5 mg/mL meloxicam
Applicant Name: Zoetis Australia Pty Ltd
Applicant ACN: 156 476 425
Summary of Use: For alleviation of inflammation and pain of musculoskeletal disorders in dogs
Date of Registration: 8 November 2013
Label Approval No: 69372/60628
Product Name: Aristopet Animal Health Fly Repellent For Dogs
Active Constituent/s: 13 g/L n-octyl bicycloheptene dicarboximide, 17 g/L di-n-propyl isocinchomeronate, 8 g/L piperonyl butoxide, 17 g/L diethyl toluamide, 5 g/L citronella oil, 2 g/L pyrethrins
Applicant Name: Aristopet Pty Ltd
Applicant ACN: 145 418 882
Summary of Use: An external parasiticide for use on dogs to kill and repel flies
Date of Registration: 11 November 2013
Label Approval No: 69173/60130
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 14
Notice of Registrations – Veterinary Chemical Products
Product Name: Aristopet Animal Health Stop-Itch For Dogs & Cats
Active Constituent/s: 15 g/L povidone-iodine, 6 g/L iodophor (equivalent to 0.75% available iodine)
Applicant Name: Aristopet Pty Ltd
Applicant ACN: 145 418 882
Summary of Use: For the treatment of eczema, non-specific dermatoses and fungal infections, including ringworm (Microsporum spp. and Trichophyton spp.) in dogs and cats
Date of Registration: 11 November 2013
Label Approval No: 68944/59447
Product Name: Abbeyneo Antibiotic Feed Additive
Active Constituent/s: 600 g/kg neomycin (as neomycin sulphate)
Applicant Name: Abbey Laboratories Pty Ltd
Applicant ACN: 156 000 430
Summary of Use: For the treatment of bacterial scours caused by organisms sensitive to neomycin, including neomycin sensitive strains of E.coli, Salmonella spp., Pseudomonas spp., in poultry, pigs and cattle
Date of Registration: 12 November 2013
Label Approval No: 67805/56898
2. VARIATIONS
Product Name: Draxxin Injectable Solution
Applicant Name: Zoetis Australia Pty Ltd
Applicant ACN: 156 476 425
Summary of Variation: To extend the use of the product to include dairy heifers up to the point of first mating
Date of Variation: 1 November 2013
Label Approval No: 60018/52864
Product Name: Pastoral AG Ivermectin Pour-On for Cattle
Applicant Name: Titan AG Pty Ltd
Applicant ACN: 122 081 574
Summary of Variation: To change the product name from ‘ECOMECTIN CATTLE POUR-ON’ to ‘PASTORAL AG IVERMECTIN POUR-ON FOR CATTLE’
Date of Variation: 1 November 2013
Label Approval No: 52711/60038
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 15
* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer Other Notices – Licensing of Veterinary Chemical Manufacturers
OTHER NOTICES
Licensing of Veterinary Chemical Manufacturers
Pursuant to Part 8 of the Agricultural and Veterinary Chemical Codes scheduled to the Agricultural and Veterinary
Chemicals Code Act 1994, the APVMA hereby gives notice that it has taken action, with respect to the licensing of
the following veterinary chemical manufacturers, with effect from the dates shown.
For a comprehensive listing of all licensed manufacturers please see the APVMA’s website www.apvma.gov.au.
1. NEW LICENCES
BIOPROTON PTY LTD LICENCE NO: 4096
ACN: 059 093 417
55 Dulacca Street
ACACIA RIDGE QLD 4110
Product Types:*
Category 4: premix (powders)
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation
including blending, packaging, labelling, analysis and testing (enzyme assay),
storage and release for supply.
Licence Issued: 2 October 2013
2. CHANGES TO EXISTING LICENCES
BALHAN INDUSTRIAL CO.
PROPRIETARY LIMITED
LICENCE NO: 2111
ACN: 004 705 435
81–89 Buckley Grove
MOOLAP VIC 3220
Product Types: *
Category 2: pastes, powders and liquids
Step(s) of Manufacture: Formulation including blending, filling, packaging,
labelling, analysis and testing (physical and chemical), storage and release for
supply.
Amended Licence Issued: 4 October 2013
Removal of Category 4
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 16
* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer Other Notices – Licensing of Veterinary Chemical Manufacturers
THE STATE OF VICTORIA
ACTING THROUGH THE
DEPARTMENT OF
ENVIRONMENT AND PRIMARY
INDUSTRIES
LICENCE NO: 1071
ABN: 90 719 052 204
Pig Health and Research Unit
Corner Taylor Street and
Midland Highway
EPSOM VIC 3551
Product Types: *
Category 1: Bacterial vaccines
Step(s) of Manufacture: Quality assurance (QA) of raw materials, bacterial
fermentation, formulation including blending, aseptic filling, packaging, labelling,
sterilisation (heat), analysis and testing (physical, chemical, microbiological,
sterility, immunobiological, serological and haemolysin assay), storage and
release for supply
Amended Licence Issued: 2 October 2013
Amended company name, ABN and steps of manufacture
PHARMASYNTH PTY LTD
LICENCE NO: 1086
ACN: 074 656 509
2806 Ipswich Road
DARRA QLD 4076
Product Types: *
Category 1: Vaccine and sterile products
Step(s) of Manufacture: Quality assurance (QA) of raw materials, cell
propagation, virus cultivation, filling, packaging, labelling, sterilisation (heat and
filtration), microbiological reduction treatment (heat, filtration, chemical), analysis
and testing (physical), storage.
Amended Licence Issued: 9 October 2013
Amended steps of manufacture
NORTHERN SERUMS PTY LTD LICENCE NO: 1058
ACN: 003 809 318
1295 Hogarth Range Road
HOGARTH RANGE NSW 2469
Product Types: *
Category 1: Immunobiologicals (tick antiserum)
Step(s) of Manufacture: Quality assurance (QA) of raw materials, management
and immunisation of donor animals, serum collection, formulation including
blending, aseptic filling, packaging, labelling, sterilisation (heat, chemical and
filtration), microbiological reduction treatment (heat and filtration), analysis and
testing (physical), storage and release for supply.
Amended Licence Issued: 17 October 2013
Amendment to steps of manufacture
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 17
* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer Other Notices – Licensing of Veterinary Chemical Manufacturers
RABAR PTY LTD LICENCE NO: 4051
ACN: 010 969 776
152 Enterprise Drive
BEAUDESERT QLD 4285
Product Types: *
Category 4: Supplements (liquids and powders) and premixes
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation
including blending, wet milling, dry milling, filling, packaging, labelling, analysis
and testing (physical), storage and release for supply
Amended Licence Issued: 25 October 2013
Amended product types
ARISTOPET PTY LTD LICENCE NO: 2211
ACN: 145 418 882
118 Links Avenue South
EAGLE FARM QLD 4009
Product Types: *
Category 2: Tablets, creams/lotions, ointments, pastes, powders, sprays, liquids and suspensions
Category 3: Liquids, sprays, powders and tablets (soluble for aquarium)
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation
including blending, dry milling, granulation, filling, packaging, labelling, blister
packaging, tableting, analysis and testing (physical), storage and release for
supply.
Amended Licence Issued: 31 October 2013
Amendment to steps of manufacture and key personnel
3. LICENCE CANCELLATIONS
The APVMA has cancelled the following licences under subsection 127(1) of the Agricultural and Veterinary
Chemicals Code [‘the Agvet Code’].
BRIAN F MILLAR TRADING
AS KILLYPTUS PRODUCTS
LICENCE NO: 3018
QLD BN: 5477773
Unit 21, Forest Glen
Shopping Centre
Mons Road
FOREST GLEN QLD 4556
Date Cancelled: 2 October 2013
Reason for Cancellation: s.127(1)(d)
FORT DODGE AUSTRALIA
PTY LIMITED
LICENCE NO: 1005
ACN: 000 074 902
2152 Castlereagh Road
PENRITH NSW 2750
Date Cancelled: 4 October 2013
Reason for Cancellation: s.127(1)(e)
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 18
* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer Other Notices – Licensing of Veterinary Chemical Manufacturers
HOSPIRA AUSTRALIA PTY
LTD
LICENCE NO: 1067
ACN: 097 064 330
1–5, 2–10, 7–23, 25–39
Lexia Place
MULGRAVE VIC 3170
Date Cancelled: 11 October 2013
Reason for Cancellation: s.127(1)(d)
BRUCE MALCOLM GRAHAM
TRADING AS: BRUCE
GRAHAM CONSULTING
LICENCE NO: 6143
ABN: 14 644 986 828
1/125-127 Bettington Road
OATLANDS NSW 2117
Date Cancelled: 17 October 2013
Reason for Cancellation: s.127(1)(d)
DEPARTMENT OF PRIMARY
INDUSTRIES AND FISHERIES,
BIOSECURITY SCIENCES
LABORATORY
LICENCE NO: 6146
ABN: 78 342 684 030
665 Fairfield Road
YEERONGPILLY QLD 4105
Date Cancelled: 24 October 2013
Reason for Cancellation: s.127(1)(d)
INTEC INDUSTRIES PTY LTD LICENCE NO: 3034
ACN: 115 361 834
17 Raymond Road
LAVERTON NORTH VIC 3026
Date Cancelled: 14 October 2013
Reason for Cancellation: s.127(1)(d)
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 19
* Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer Other Notices – Licensing of Veterinary Chemical Manufacturers
4. REVOCATION OF LICENCE CANCELLATION
The APVMA has revoked the cancellation of the following licences under subsection 127(7) of the Agricultural and
Veterinary Chemicals Code [‘the Agvet Code’].
METROPOLITAN HEALTH
SERVICE TRADING AS
PHARMACEUTICAL TESTING
FACILITY (PTF),
DEPARTMENT OF
MICROBIOLOGY, PATHWEST
LABORATORY MEDICINE WA
LICENCE NO: 6097
ABN: 13 993 250 709
Level 3
Hay Street Building
Princess Margaret Hospital for
Children
Roberts Road
SUBIACO WA 6008
Date Cancellation Revoked: 4 October 2013
APVMA CONTACT
MQL Officer
Manufacturing, Quality and Licensing
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4899
Fax: +61 2 6210 4741
Email: [email protected]
Commonwealth of Australia Gazette No. APVMA 23, Tuesday, 19 November 2013 Agricultural and Veterinary Chemicals Code Act 1994 20
Other Notices – Addendum to the Record of Approved Active Constituents
Addendum to the Record of Approved Active Constituents
The current Record of Approved Active Constituents for Registered Chemical Products is also accessible from the
APVMA website, www.apvma.gov.au.
APPROVED SINCE GAZETTE NO. 22
For use in agricultural and/or veterinary chemical products:
Common Name Approval Holder Manufacturer and Site of Manufacture Approval No.
PIRIMICARB SYNGENTA
AUSTRALIA PTY
LTD
Hunan Haili Chemical Industry Co., Ltd
Sujiadu Deshan
Changde
Hunan 415001
P. R. China
69007
BROMADIOLONE ACTIVA S.R.L. Dr Tezza Srl
Via Tre Ponti, 22-37050
S. Maria Di Zevio (VR)
Italy
67898
APVMA CONTACT
For further information please contact:
Application Management and Enquiries
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Phone: +61 2 6210 4701
Fax: +61 2 6210 4721
Email: [email protected]