No. APVMA 20, Tuesday, 26 October 2010 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.
26466 Cat. No. 0189623
ISSN 1837 - 7629
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 Agricultural and Veterinary Chemicals Code Act 1994 2
© Commonwealth of Australia 2010
This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process
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Email: [email protected]
Website: www.ag.gov.au/cca
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 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
From February 2010, the APVMA will publish the APVMA Gazette in electronic format only. The APVMA Gazette and information
about subscribing to the gazette alert service are available on the APVMA website, www.apvma.gov.au.
Copies of the APVMA Gazette from November 1999 until July 2009 will remain available from the APVMA website.
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Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 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 Compulsory Not to Supply Notice: 4 Farmers Pty Ltd ..........................................................................................................21 Application Summaries.........................................................................................................................................................22 Addendum to the Record of Approved Active Constituents..................................................................................................26
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 Agricultural and Veterinary Chemicals Code Act 1994 4
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
No entries.
2. AGRICULTURAL PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS
Product Name: Aquatain AMF Liquid Mosquito Film Active Constituent/s: 754g/L polydimethylsiloxane Applicant Name: Aquatain Products Pty Ltd Applicant ACN: 131 287 271 Summary of Use: For the control of mosquito’s in standing water in domestic/suburban areas. Date of Registration: 15 October 2010 Label Approval No: 62820/44039
3. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Product Name: Pure Blue Multi Action Jumbo Tabs Active Constituent/s: 800g/kg chlorine (CI) present as trichloroisocyanuric acid, 7g/kg copper present as copper
sulfate pentahydrate also contains 20g/kg boric acid Applicant Name: Pool Products Of Australia Pty Ltd Applicant ACN: 085 385 511 Summary of Use: For control of algae and bacteria in outdoor swimming pools Date of Registration: 30 September 2010 Label Approval No: 62905/1kg/1009, 62905/2kg/1009, 62905/10kg/1009
Product Name: Agritrading Atrazine 900 WG Herbicide Active Constituent/s: 900g/kg atrazine Applicant Name: Agritrading Pty Limited Applicant ACN: 134 291 295 Summary of Use: For the control of weeds and grasses in sorghum, maize, sugar cane, TT-canola, lucerne and
for fallow weed area maintenance and other situations. Date of Registration: 6 October 2010 Label Approval No: 64684/50135
Product Name: Campbell Passtox Clear Herbicide Active Constituent/s: 220g/L DSMA Applicant Name: Colin Campbell (Chemicals) Pty Ltd Applicant ACN: 000 045 590 Summary of Use: For the control of paspalum, summer grass, Mullumbimby couch and other sedges in turf. Date of Registration: 7 October 2010 Label Approval No: 65189/50368
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 Agricultural and Veterinary Chemicals Code Act 1994 5
Product Name: Apparent Chlorpyrifos 500 EC Insecticide Active Constituent/s: 500g/L chlorpyrifos (an anticholinesterase compound) Applicant Name: Apparent Pty. Ltd. Applicant ACN: 143 724 136 Summary of Use: For the control of weeds and grasses in range of broadacre crops and for fallow area
maintenance and other situations. Date of Registration: 7 October 2010 Label Approval No: 65160/50307
Product Name: Cislin Ultra Residual Insecticide Active Constituent/s: 20g/L S-bioallethrin, 25g/L deltamethrin Applicant Name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of Use: For the control of various insect pests in domestic and industrial situations. Date of Registration: 7 October 2010 Label Approval No: 63129/44814
Product Name: OzCrop Sulgran WG Fungicide / Miticide Active Constituent/s: 800g/kg sulphur (S) present as wettable sulphur Applicant Name: CMS Trade Pty Ltd Applicant ACN: 086 927 157 Summary of Use: For the control of certain fungal diseases, mites and white louse scale in a range of
horticultural crops. Date of Registration: 7 October 2010 Label Approval No: 65262/50545
Product Name: Ultraxide Liquid Disinfectant Active Constituent/s: 150g/L glutaraldehyde, 100g/L benzalkonium chloride Applicant Name: Zagro Singapore Pte Ltd Applicant ACN: N/A Summary of Use: For sanitising sheds, animal pens and farming equipment. Date of Registration: 7 October 2010 Label Approval No: 63131/44818
Product Name: Titan Chlorothalonil 720 Fungicide Active Constituent/s: 720g/L chlorothalonil Applicant Name: Titan Ag Pty Ltd Applicant ACN: 122 081 574 Summary of Use: For the control of fungal diseases. Date of Registration: 8 October 2010 Label Approval No: 62668/50254
Product Name: Hovex Sandalwood Mosquito Coils Active Constituent/s: 4g/kg D-allethrin Applicant Name: Pascoe's Pty Ltd Applicant ACN: 055 220 463 Summary of Use: For control of mosquitoes in and around the home. Date of Registration: 8 October 2010 Label Approval No: 64836/49405
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 Agricultural and Veterinary Chemicals Code Act 1994 6
Product Name: Agriron 900 WG Herbicide Active Constituent/s: 900g/kg diuron Applicant Name: Agri Environmental Pty Ltd Applicant ACN: 105 841 110 Summary of Use: For the control of weeds in cereals, cotton, sugarcane, citrus, apples, asparagus, bananas,
pawpaw, pears, pineapples, vineyards, coffee, lucerne, lupins, perennial grass seed crops, rights-of-way, and commercial and industrial areas.
Date of Registration: 11 October 2010 Label Approval No: 64727/5kg/0610, 64727/10kg/0610, 64727/15kg/0610, 64727/20kg/0610, 64727/0610
Product Name: Aako Leopard 100 EC Herbicide Active Constituent/s: 100g/L quizalofop-p-ethyl Applicant Name: Aako Australia Pty Limited Applicant ACN: 122 279 109 Summary of Use: For control of certain grass weeds in broadleaf crops. Date of Registration: 11 October 2010 Label Approval No: 65168/50318
Product Name: RC Amine 625 Selective Herbicide Active Constituent/s: 625g/L 2,4-D present as the dimethylamine and diethanolamine salts Applicant Name: Ruralchem Pty Ltd Applicant ACN: 140 235 356 Summary of Use: For the control of broadleaf weeds in cereals, pastures, fallow and other crops. Date of Registration: 11 October 2010 Label Approval No: 64700/20L/0310, 64700/110L/0310, 64700/1000L/0310, 64700/0310
Product Name: Tilt 250 EC Fungicide Active Constituent/s: 250g/L propiconazole Applicant Name: Syngenta Crop Protection Pty Limited Applicant ACN: 002 933 717 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 October 2010 Label Approval No: 62205/50040
Product Name: Eraze 360 Bi-Aquatic Herbicide Active Constituent/s: 360g/L glyphosate present as the isopropylamine salt Applicant Name: Ecofertiliser Pty Ltd Applicant ACN: 100 684 786 Summary of Use: For the control of various annual, perennial, aquatic and woody weeds in various situations. Date of Registration: 11 October 2010 Label Approval No: 65015/49880
Product Name: Aquapro Algae Inhibitor Active Constituent/s: 50g/L copper present as a complex blend of copper salts, 150g/L benzalkonium chloride Applicant Name: M I International Pty Ltd T/A Lo-Chlor Chemicals Applicant ACN: 002 869 089 Summary of Use: For control of black spot algae in swimming pools. Date of Registration: 11 October 2010 Label Approval No: 64534/49806
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 Agricultural and Veterinary Chemicals Code Act 1994 7
Product Name: Puffer Codling Moth Pheromone Insect Confusing Agent Active Constituent/s: 173g/L (E,E) 8,10 dodecadien-1-ol Applicant Name: Suterra LLC Applicant ACN: N/A Summary of Use: For use as a mating disruption product of codling moth in apple and pear orchards. Date of Registration: 11 October 2010 Label Approval No: 64208/47821
Product Name: Ecofleet 290 Antifouling Active Constituent/s: 565-590g/L copper present as cuprous oxide, 70-73g/L diuron Applicant Name: PPG Industries Australia Pty Ltd Applicant ACN: 055 500 939 Summary of Use: For use in controlling general marine fouling on vessels Date of Registration: 11 October 2010 Label Approval No: 63486/45788
Product Name: Country Spray Grade Ammonium Sulphate Herbicide Adjuvant Active Constituent/s: 980g/kg ammonium sulphate Applicant Name: Accensi Pty Ltd Applicant ACN: 079 875 184 Summary of Use: For use as an adjuvant with Glyphosate based herbicides to minimise antagonism when tank
mixing with flowable herbicides, and to improve performance of herbicides under adverse environmental conditions.
Date of Registration: 12 October 2010 Label Approval No: 64785/49266
Product Name: Titan Quizalofop-P-Ethyl 99.5 Herbicide Active Constituent/s: 99.5g/L quizalofop-p-ethyl Applicant Name: Titan AG Pty Ltd Applicant ACN: 122 081 574 Summary of Use: For the control of certain grass weeds in broadleaf crops. Date of Registration: 12 October 2010 Label Approval No: 53609/50018
Product Name: Hy-Clor Hi-Clon 700 Granular Pool Chlorine Active Constituent/s: 700g/kg available chlorine (Cl) present as calcium hypochlorite Applicant Name: Hy-Clor (Australia) Pty Ltd Applicant ACN: 000 655 381 Summary of Use: For control of bacteria and algae in swimming pools. Date of Registration: 12 October 2010 Label Approval No: 64269/2kg/0809, 64269/4kg/0809, 64269/10kg/0809, 64269/25kg/0809
Product Name: AC Redback Insecticide Active Constituent/s: 400g/L fenamiphos Applicant Name: Axichem Pty Ltd Applicant ACN: 131 628 594 Summary of Use: For the control of nematodes and sucking insects in a variety of crops and turf. Date of Registration: 12 October 2010 Label Approval No: 65039/1L/0510, 65039/5L/0510, 65039/20L/0510, 65039/0510
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 Agricultural and Veterinary Chemicals Code Act 1994 8
Product Name: AC Clearoff Herbicide Active Constituent/s: 480g/L trifluralin Applicant Name: Axichem Pty Ltd Applicant ACN: 131 628 594 Summary of Use: For the control of weeds annual grasses and broadleaf weeds in agricultural and horticultural
crops. Date of Registration: 13 October 2010 Label Approval No: 64754/0310, 64754/110L/0310, 64754/200L/0310, 64754/1000L/0310, 64754/20L/0310
Product Name: AW Clash 750 SG Herbicide Active Constituent/s: 750g/kg clopyralid present as the potassium salt Applicant Name: Agri West Pty Limited Applicant ACN: 108 899 181 Summary of Use: For control of a wide range of broadleaf weeds in wheat, barley, oats, triticale, canola,
pastures and fallow land. Date of Registration: 14 October 2010 Label Approval No: 65211/50416
Product Name: AC Dozer Herbicide Active Constituent/s: 200g/L fluroxypyr present as the methyl heptyl ester Applicant Name: Axichem Pty Ltd Applicant ACN: 131 628 594 Summary of Use: For use in fallow, lucerne, maize, millet, pasture, poppies, sorghum, sugarcane, sweet corn
and winter cereals to control broadleaf weeds, and for use in agricultural non-crop, commercial and industrial areas, forests, pastures and rights-of-way to control woody weeds.
Date of Registration: 14 October 2010 Label Approval No: 65038/49940
Product Name: AC Tulloch 750 Herbicide Active Constituent/s: 750g/kg triasulfuron Applicant Name: Axichem Pty Ltd Applicant ACN: 131 628 594 Summary of Use: For the pre-emergent control of annual ryegrass, paradoxa grass and broadleaf weeds in
wheat, and for post-emergent control of certain broadleaf weeds in winter cereal. Date of Registration: 14 October 2010 Label Approval No: 64921/49587
Product Name: Exile Herbicide Active Constituent/s: 200g/L glufosinate-ammonium Applicant Name: Agricrop Pty Ltd Applicant ACN: 100 473 309 Summary of Use: For the non-residual control of broadleaf and grass weeds in various situations. Date of Registration: 15 October 2010 Label Approval No: 64814/5L/0610, 64814/10L/0610, 64814/20L/0610, 64814/200L/0610, 64814/1-200L/0610
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 Agricultural and Veterinary Chemicals Code Act 1994 9
Product Name: Superway Trifluralin 480 Herbicide Active Constituent/s: 480g/L trifluralin Applicant Name: Superway Garden Ag & Pest Products Pty Ltd Applicant ACN: 056 553 274 Summary of Use: For the control of annual grasses and certain broadleaf weeds in horticultural and agricultural
crops. Date of Registration: 18 October 2010 Label Approval No: 64621/48788
Product Name: Diafil Inert Dust Insecticide Active Constituent/s: 900g/kg amorphous silica Applicant Name: Filchem Australia Pty. Limited Applicant ACN: 003 078 117 Summary of Use: For control of insect pests in farm stored seed and feed grain; grain for human consumption
not handled by grain handling authorities; grain handling machinery; grain storage; food processing and warehousing facilities.
Date of Registration: 18 October 2010 Label Approval No: 64646/48843
Product Name: VC-700 Surfactant Active Constituent/s: 350g/L soyal phospholipids, 350g/L propionic acid Applicant Name: Victorian Chemical Company Proprietary Limited Applicant ACN: 004 188 863 Summary of Use: For use as an adjuvant and surfactant. Date of Registration: 18 October 2010 Label Approval No: 65396/50828
Product Name: Blue Star Mancozeb 750 DF Fungicide Active Constituent/s: 750g/kg mancozeb Applicant Name: Blue Star Chemicals Pty Ltd Applicant ACN: 134 548 459 Summary of Use: For the control of certain fungus diseases in certain fruit, vegetable, ornamentals and field
crops. Date of Registration: 19 October 2010 Label Approval No: 65180/50338
Product Name: Smart Tri-Allate 500 EC Herbicide Active Constituent/s: 500g/L triallate Applicant Name: Crop Smart Pty Ltd Applicant ACN: 093 927 961 Summary of Use: For the control of wild oats in wheat, triticale, chickpea, barley, peas, linseed, lupins, canola,
faba beans and safflower. Date of Registration: 19 October 2010 Label Approval No: 64496/49470
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 Agricultural and Veterinary Chemicals Code Act 1994 10
Product Name: Vectorforce Thermal Fogging & ULV Insecticide Concentrate Active Constituent/s: 25g/L cypermethrin Applicant Name: Sherwood Chemicals Public Company Limited. Applicant ACN: N/A Summary of Use: For the knockdown control of adult mosquitoes, biting midges, flies and cockroaches in and
around domestic, public service areas, agricultural buildings, commercial and industrial areas, refuse tips and breeding areas.
Date of Registration: 19 October 2010 Label Approval No: 65430/50905
Product Name: Smart Metsulfron 600 WG Herbicide Active Constituent/s: 600g/kg metsulfuron-methyl Applicant Name: Crop Smart Pty Ltd Applicant ACN: 093 927 961 Summary of Use: For control of certain brush and broadleaf species in native pastures, rights of way and
commercial and industrial areas and for the control of certain broadleaf weeds in winter cereal crops, grass pastures and pasture renovation.
Date of Registration: 19 October 2010 Label Approval No: 65047/49990
Product Name: Rentokil Advanced-Kil Blocks Active Constituent/s: 0.03g/kg difethialone Applicant Name: Liphatech S.A.S. Applicant ACN: N/A Summary of Use: Bait product for control of rats and mice. Date of Registration: 20 October 2010 Label Approval No: 65357/50748
Product Name: Chemical House H2 Light Organic Solvent Preservative Active Constituent/s: 2.6g/L permethrin (25:75) Applicant Name: Chemical House Pty Ltd Applicant ACN: 010 418 569 Summary of Use: For protection of seasoned timber against termites and wood borers for use in H2 situations
(inside and above ground). Date of Registration: 20 October 2010 Label Approval No: 65248/50514
Product Name: Rainbow Haloxyfop 520 Herbicide Active Constituent/s: 520g/L haloxyfop present as the haloxyfop-r methyl ester Applicant Name: Shandong Rainbow International Co., Ltd. Applicant ACN: N/A Summary of Use: For the post-emergent control of a wide range of annual and perennial grass weeds in grain
legume and oilseed crops, lucerne, medic and clover pasture and seed crops, forestry, bananas, citrus, grapes, pineapples, pome and stone fruit, pyrethrum, tropical fruit and nut crops.
Date of Registration: 20 October 2010 Label Approval No: 60648/50521
4. LISTED REGISTRATIONS
No entries.
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 Agricultural and Veterinary Chemicals Code Act 1994 11
5. VARIATIONS
Product Name: Go Natural Organic Herbicide Applicant Name: Horticulture Trade Corporation International Pty. Ltd. Applicant ACN: 096 721 078 Summary of Variation: To change product name from INTERCEPTOR ORGANIC WEED SPRAY READY TO USE to
GO NATURAL ORGANIC HERBICIDE, to update label and add 500mL and 750mL pack size. Date of Variation: 8 October 2010 Label Approval No: 60162/50880
Product Name: Folicur 430 SC Fungicide Applicant Name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of Variation: To include the control of Sclerotinia rot on lettuces. Date of Variation: 12 October 2010 Label Approval No: 46794/50327
Product Name: Poolkare Chemicals Bingo-B Applicant Name: Wobelea Pty Ltd T/A Poolkare Chemicals Applicant ACN: 005 363 833 Summary of Variation: To confirm formulation and update labels at the request of the APVMA. Date of Variation: 18 October 2010 Label Approval No: 30815/29754
Product Name: Rolldown 450 Herbicide Applicant Name: Certich A&S Pty Ltd Applicant ACN: 131 049 502 Summary of Variation: Change in product name from ROUNDOWN 450 HERBICIDE to ROLLDOWN 450
HERBICIDE. Date of Variation: 20 October 2010 Label Approval No: 64674/51272
Product Name: Surefire Vista 200SC Insecticide Applicant Name: PCT Holdings Pty Ltd Applicant ACN: 099 023 962 Summary of Variation: To remove uses on bananas, forestry, mushrooms, pasture and sorghum and to add control
of various insect pests on asparagus, swede, turnips, sweet potato and ginger. Date of Variation: 20 October 2010 Label Approval No: 63581/50826
6. RESTRICTED PRODUCT VARIATION
Product Name: Control-A-Bird Agent Active Constituent/s: 110g/kg fenthion (an antichloinesterase compound) Applicant Name: Control A Bird Pty Limited Applicant ACN: 004 478 951 Summary of Variation: Outcome of the review of Fenthion and restricted chemical status for Fenthion bird control
products Date of Variation: 18 October 2010 Label Approval No: 42202/20kg/1208
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 Agricultural and Veterinary Chemicals Code Act 1994 12
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.
7. RESTRICTED PRODUCT
No entries.
8. VETERINARY PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS
No entries.
9. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Product Name: Frontline Original For Cats Active Constituent/s: 100g/L fipronil Applicant Name: Merial Australia Pty Ltd Applicant ACN: 071 187 285 Summary of Use: For control of ectoparasites in cats. Date of Registration: 8 October 2010 Label Approval No: 65457/50969
Product Name: Arthri Zing Joint Powder For Dogs Active Constituent/s: Each 2.5g contains 500mg glucosamine HCl, 400mg chondroitin sulfate Applicant Name: Nature Vet Pty Limited Applicant ACN: 002 692 426 Summary of Use: May help reduce non-infectious joint inflammation in dogs. Date of Registration: 12 October 2010 Label Approval No: 64745/49127
Product Name: Vibe Vitamin B12 Injection Active Constituent/s: 2mg/mL hydroxocobalamin acetate Applicant Name: Agvantage Pty Ltd Applicant ACN: 097 970 280 Summary of Use: A vitamin B12 injection for the treatment of vitamin B12 deficiency in lambs, calves, sheep
and cattle. Date of Registration: 12 October 2010 Label Approval No: 61956/41964
Product Name: Equine Bute Paste Anti-Inflammatory Oral Paste Active Constituent/s: 200mg/mL phenylbutazone Applicant Name: Randlab Australia Pty Ltd Applicant ACN: 114 948 837 Summary of Use: For use as an anti-inflammatory, analgesic and antipyretic for the relief of painful
musculoskeletal conditions in horses. Date of Registration: 12 October 2010 Label Approval No: 63283/45232
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 Agricultural and Veterinary Chemicals Code Act 1994 13
Product Name: Equiheal Stable Ointment Active Constituent/s: 324g/kg sulphur Applicant Name: Oil Transport Management Pty Ltd Applicant ACN: 112 829 151 Summary of Use: An ointment for use as an aid in the treatment of greasy heel & non-specific dermatitis in
horses. Date of Registration: 18 October 2010 Label Approval No: 63664/46180
Product Name: Outback Vet Omega Oil Omega 3 & 6 Fatty Acid Supplement Active Constituent/s: Each 1g contains a minimum of 120mg linolenic acid, 38mg linoleic acid, 59mg
docosahexaenoic acid, 85mg eicosapentaenoic acid Applicant Name: Nature Vet Pty Limited Applicant ACN: 002 692 426 Summary of Use: To aid in the treatment of allergic and inflammatory dermatological conditions responsive to
polyunsaturated fatty acids in dogs. Date of Registration: 19 October 2010 Label Approval No: 62667/43587
Product Name: Easotic Ear Suspension For Dogs Active Constituent/s: 1505IU/mL gentamicin (as the sulphate), 1.11mg/mL hydrocortisone aceponate, 15.1mg/mL
miconazole (as the nitrate) Applicant Name: Virbac (Australia) Pty Ltd Applicant ACN: 003 268 871 Summary of Use: For the treatment of otitis externa of bacterial, fungal or inflammatory origin. Date of Registration: 20 October 2010 Label Approval No: 63501/45815
Product Name: Vetafarm Spectovet Antibiotic Soluble Powder For Ornamental & Show Poultry Active Constituent/s: Each gram contains 222mg lincomycin (as the hydrochloride monohydrate), 445mg
spectinomycin (as the dihydrochloride pentahydrate). Applicant Name: Vetafarm Pty. Ltd. Applicant ACN: 059 895 153 Summary of Use: A powder antibiotic for the treatment of chronic respiratory disease by avian mycoplasmas in
show and ornamental poultry. Date of Registration: 20 October 2010 Label Approval No: 63884/46819
10. LISTED REGISTRATIONS
No entries.
11. VARIATIONS
Product Name: Pharmachem Halothane BP Applicant Name: Bocko Pty Ltd & Flexsky Pty Ltd (In Partnership) T/A Pharmachem Applicant ACN: 078 722 371 / 105 967 575 Summary of Variation: To change name from LASER ANIMAL HEALTH HALOTHANE BP to PHARMACHEM
HALOTHANE BP and label approval. Date of Variation: 8 October 2010 Label Approval No: 49894/50004
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 Agricultural and Veterinary Chemicals Code Act 1994 14
Product Name: Coopers Revalor 400 Growth Promotant For Grass Fed Heifers And Steers Applicant Name: Intervet Australia Pty Ltd Applicant ACN: 008 467 034 Summary of Variation: To change product name from REVALOR–400 GROWTH PROMOTANT FOR GRASS FED
HEIFFERS AND STEERS to COOPERS REVALOR 400 GROWTH PROMOTANT FOR GRASS FED HEIFFERS AND STEERS, to add a pack size, and to approve label to include a Trade Advice Statement (ESI).
Date of Variation: 8 October 2010 Label Approval No: 48945/51059
Product Name: Pharmachem Isoflurane Inhalation Anaesthetic Applicant Name: Bocko Pty Ltd & Flexsky Pty Ltd (In Partnership) T/A Pharmachem Applicant ACN: 078 722 371 / 105 967 575 Summary of Variation: To change the name from LASER ANIMAL HEALTH ISOFLURANE INHALATION
ANAESTHETIC to PHARMACHEM ISOFLURANE INHALATION ANAESTHETIC and label approval.
Date of Variation: 14 October 2010 Label Approval No: 53491/50005
Product Name: CopperEX Bullets Applicant Name: International Animal Health Products Pty Ltd Applicant ACN: 003 185 699 Summary of Variation: To change the name of the product from CUE BULLETS to COPPEREX BULLETS. Date of Variation: 18 October 2010 Label Approval No: 57003/48205
12. RESTRICTED PRODUCT VARIATION
No entries.
Notice of Registrations
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 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
BEAPHAR AUSTRALIA PTY LTD
LICENCE NO: 2211
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, tableting, analysis and testing (physical), storage and release for supply.
ACN: 145 418 882
118 Links Avenue South
EAGLE FARM QLD 4009
Licence Issued: 29/09/2010
PHARMPLEX PTY LTD LICENCE NO: 2207
Product Types:* • Category 2: Capsules, pellets/boluses, powders, granules, liquids and
hormone impregnated foam sponges • Category 4: Premixes and supplements
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, tableting, pellet extrusion, capsule filling from bulk, analysis and testing (physical and chemical), storage and release for supply.
ACN: 145 071 165
914 Croobyar Road
MILTON NSW 2538
Licence Issued: 29/09/2010 with special conditions
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 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
RTH SCIENTIFIC SERVICES PTY LTD
LICENCE NO: 6166
Product Types:* • Category 6: Single step manufacture
Step(s) of Manufacture: Analysis and testing (physical and chemical).
ACN: 112 358 915
47 Oak Place
MACKENZIE QLD 4156
Licence Issued: 29/09/2010
TROY LABORATORIES PTY LTD
LICENCE NO: 1092
Product Types:* • Category 1: Sterile products and terminally sterilised ointment • Category 2: Tablets, creams/lotions, ointments, gels, pastes, powders,
sprays, granules, suspensions and liquids • Category 3: Liquids and sprays • Category 4: Supplements
ACN: 000 283 769
31-35 Glendenning Road
GLENDENNING NSW 2761
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, dry milling, filling, aseptic filling, packaging, strip, blister or sachet packaging, labelling, sterilisation (heat and filtration), microbiological reduction treatment (filtration and chemical), granulation, tableting, analysis and testing (physical and chemical), storage and release for supply.
Licence Issued: 13/09/2010
2. CHANGES TO EXISTING LICENCES
ACCESS INDUSTRIES FOR THE DISABLED TRADING AS ACCESS INDUSTRIES
LICENCE NO: 6056
Product Types: * • Category 6: Single step manufacture
Step(s) of Manufacture: Secondary packaging, secondary labelling, storage.
ACN: 001 797 511
Units 10&11
167 Prospect Highway
SEVEN HILLS NSW 2147 Amended Licence Issued: 28/09/2010
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 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
AUSTRALIAN LABORATORY SERVICES PTY. LTD.
LICENCE NO: 6136
Product Types: * • Category 6: Single step manufacture
Step(s) of Manufacture: Quality assurance (QA) of raw materials, analysis and testing (physical, chemical, Limulus Amoebocyte Lysate Test [LAL], other pharmacological test, antibiotic assay, sterility testing, microbiological, immunobiological and serological).
ACN: 009 936 029
4 Westall Road
SPRINGVALE VIC 3171
Amended Licence Issued: 12/09/2010
CAMPBELL BROTHERS LIMITED TRADING AS DELTREX CHEMICALS
LICENCE NO: 6003
Product Types: * • Category 6: Single step manufacture
Step(s) of Manufacture: Filling, packaging, labelling, storage and release for supply.
ACN: 009 657 489
7-11 Burr Court
LAVERTON NORTH VIC 3026
Amended Licence Issued: 23/09/2010
COLBAR QSR PTY. LTD. LICENCE NO: 2158
Product Types: * • Category 2: (Non-sterile veterinary preparations except externally applied
ectoparasiticides, premixes and supplements) –liquids. • Category 3: (Ectoparasiticides) –liquids, pastes, sprays and powders.
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, analysis and testing (physical and microbiological), storage and release for supply.
ACN: 080 075 921
86 Waterview Close
DANDENONG SOUTH VIC 3175
Amended Licence Issued: 12/09/2010
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 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
EML PTY LTD LICENCE NO: 6031
Product Types: * • Category 6: Single step manufacture
Step(s) of Manufacture: Analysis and testing (microbiological, Limulus Amoebocyte Lysate test [LAL]).
ACN: 006 308 774
425-431, 437 Canterbury Road
SURREY HILLS VIC 3127
Amended Licence Issued: 12/09/2010
MENTHOLATUM AUSTRALASIA PTY. LTD.
LICENCE NO: 2038
Product Types: * • Category 2: (Non-sterile veterinary preparations other than
ectoparasiticides and premixes and supplements) – Chocolate-based solid dosage forms.
Step(s) of Manufacture: Formulation including blending, filling, packaging, labelling, strip, blister or sachet packaging, analysis and testing (physical and chemical), storage and release for supply.
ACN: 005 414 488
12-16 Janine Street
SCORESBY VIC 3179
Amended Licence Issued: 07/09/2010
PHARMAPAK TECHNOLOGIES PTY LTD
LICENCE NO: 6107
Product Types: * • Category 6: Single step manufacture
Step(s) of Manufacture: Quality assurance (QA) of raw materials, filling, packaging, labelling, strip, blister and sachet packaging, storage and release for supply.
ACN: 093 794 104
7 Inman Road
DEE WHY NSW 2099
Amended Licence Issued: 03/09/2010
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 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
STAYSOUND (QLD) PTY LTD LICENCE NO: 2183
Product Types: * • Category 2: Ointments, poultices and liquids. • Category 4: Premixes and supplements.
Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, dry milling of powders, filling, packaging, labelling, analysis and testing (physical), storage and release for supply.
ACN: 087 379 002
2/27 Sinclair Street
LABRADOR QLD 4215
Amended Licence Issued: 12/09/2010
3. LICENCE CANCELLATIONS
The APVMA has cancelled the following licences under subsection 127(1) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code’].
AMDEL LIMITED LICENCE NO: 6164
Date Cancelled: 28/09/2010 ACN: 008 127 802
Units 16, 17 & 18
8 Leighton Place
ASQUITH NSW 2077
Reason for Cancellation: S 127(1)(e)
BIOPHARM AUSTRALIA PTY LTD
LICENCE NO: 2099
Date Cancelled: 15/09/2010 ACN: 003 425 803
111 Bronte Road
Bondi Junction NSW 2022
Reason for Cancellation: S 127(1)(d)
EASY CLEAN CHEMICALS PTY. LTD.
LICENCE NO: 2145
Date Cancelled: 07/09/2010 ACN: 006 184 050
2, 7-9 Westpool Drive
HALLAM VIC 3803 Reason for Cancellation: S127 (1) (d)
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 Agricultural and Veterinary Chemicals Code Act 1994 20
* 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
LABMARK PTY LIMITED LICENCE NO: 6105
Date Cancelled: 17/09/2010 ACN: 079 798 397
Unit 1, 16 & 17,
8 Leighton Place
ASQUITH NSW 2077
Reason for Cancellation: S 127(1)(e)
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
Dounia Houzaife GMP Officer Manufacturing Quality and Licensing Section Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4808 Fax: (02) 6210 4741 Email: [email protected]
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 Agricultural and Veterinary Chemicals Code Act 1994 21
Compulsory Not to Supply Notice: 4 Farmers Pty Ltd
NOTICE UNDER SECTION 101 OF THE AGVET CODES; NO.16 OF 2010
The APVMA has concerns about the importation of unapproved active constituents and unregistered chemical products.
4 Farmers Pty Ltd self reported that a quantity of an unregistered product Metsulfuron Methyl 600 WDG Herbicide had been imported and was currently quarantined.
The APVMA is satisfied that 4 Farmers Pty Ltd is in possession of an unregistered product without authority to do so. To ensure accountability and to prevent leakage into the Australian supply chain the APVMA decided to issue a notice under section 101 of the AgVet Codes requiring 4 Farmers Pty Ltd not to supply the product.
PRODUCT
• Metsulfuron Methyl 600 WDG Herbicide (all batches and pack sizes)
SUPPLIER DETAILS
4 Farmers Pty Ltd 1 / 70 McDowell Street Welshpool, WA, 6106
APVMA CONTACT
For further information please contact:
Drew Ward Assistant Manager Compliance Regulatory Strategy and Compliance Program Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4800 Fax: (02) 6210 4813 Email: [email protected]
Other Notices - Compulsory Not to Supply Notice: 4 Farmers Pty Ltd
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 Agricultural and Veterinary Chemicals Code Act 1994 22
Application Summaries
The APVMA publishes complete application summaries on the APVMA website, www.apvma.gov.au. They are published in weekly instalments using the date the application was accepted for assessment. If an application summary has been amended, the APVMA will publish the amended version on the website and list it separately in the APVMA Gazette Notice for Application Summaries.
As a requirement of Regulations 8C and E of the Agvet Code, some product names will appear as 'NOT AVAILABLE'.
A summary will be removed from the website 28 days after the application has been finalised. Therefore, some summaries published in this notice may have already been removed prior to the Gazette being published.
APPLICATION SUMMARIES PUBLISHED SINCE THOSE PUBLISHED IN APVMA GAZETTE NO. 20, 12 OCTOBER 2010.
Application No. Name
48483 BOMAC ABAMECTIN LV BROAD SPECTRUM ANTIPARASITIC FOR SHEEP AND LAMBS
48484 BOMAC ABAMECTIN PLUS SELENIUM ANTIPARASITIC SOLUTION FOR SHEEP AND LAMBS
49003 ANTISEPTIC QUIT-ITCH LOTION BACTERICIDE - FUNGICIDE
49173 UNITED FARMERS OXYFLUORFEN 240 EC HERBICIDE
49286 ACTARA INSECTICIDE
49449 TRIBACTRAL ANTIBACTERIAL SUSPENSION INJECTION
49458 TRIBACTRAL S ANTIBACTERIAL SOLUTION FOR INJECTION
49617 MOUSEOFF BROMADIOLONE RODENT BAIT BLOCKS
49674 MOXIMAX CATTLE POUR-ON
49685 NOT AVAILABLE
50111 ILIUM KETOPROFEN INJECTION
50327 FOLICUR 430 SC FUNGICIDE
50434 PUREBLUE CHLORINE BOOST
50497 VR DOMOSO ROLL-ON
50558 MOVENTO 240 SC INSECTICIDE
50600 NOT AVAILABLE
50601 NOT AVAILABLE
50721 SAS MOTHBALLS
50730 CHLORPYRIFOS
50770 AC TUSSEL SELECTIVE HERBICIDE
Other Notices - Application Summaries
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 Agricultural and Veterinary Chemicals Code Act 1994 23
Application No. Name
50775 IMIDACLOPRID
50777 EPOXICONAZOLE
50782 INDAZIFLAM
50853 AMGROW CATERPILLAR AND INSECT SPRAY READY TO USE
50855 AMGROW GARDEN INSECT CONTROL READY TO USE
50856 AMGROW HOME PEST CONTROL READY TO USE
50857 AMGROW CATERPILLAR AND INSECT SPRAY
50858 AMGROW GARDEN INSECT CONTROL
50860 AMGROW HOME PEST CONTROL
50882 RUMEVITE MAGNESIUM CAPSULES
50895 LAMBDA-CYHALOTHRIN
50934 GAUCHO 350 FLOWABLE SEED TREATMENT INSECTICIDE
50979 AW TRI-ALLATE HERBICIDE
51040 PENDIMETHALIN
51067 CLOQUINTOCET-MEXYL
51084 ARYSTA SELECT 360 HERBICIDE
51090 METRIBUZIN
51125 RODENTHOR RODENTICIDE PELLETS
51148 NOT AVAILABLE
51205 MACPHERSONS IMAX 700WDG HERBICIDE
51256 SCOTTS LAWNBUILDER + GRUB & INSECT CONTROL
51287 CYDECTIN LV SE LOW VOLUME ORAL DRENCH FOR SHEEP WITH SELENIUM
51289 COMBAT ORAL DRENCH FOR SHEEP AND LAMBS
51290 CYDECTIN LV LOW VOLUME DRENCH FOR SHEEP
51292 CHOICE DIUHEX CANE HERBICIDE
51358 NOT AVAILABLE
51374 DUOGARD LINE-ON FOR SMALL DOGS 5 WEEK INTEGRATED FLEA AND TICK CONTROL
51375 DUOGARD LINE-ON FOR MEDIUM DOGS 5 WEEK INTEGRATED FLEA AND TICK CONTROL
51376 DUOGARD LINE-ON FOR LARGE DOGS 5 WEEK INTEGRATED FLEA AND TICK CONTROL
51377 DUOGARD LINE-ON FOR VERY LARGE DOGS 5 WEEK INTEGRATED FLEA AND TICK
Other Notices - Application Summaries
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 Agricultural and Veterinary Chemicals Code Act 1994 24
Application No. Name
CONTROL
51386 POMADE WETTING AGENT
51414 NUFARM HORNET 500SC FUNGICIDE
50280 PRO PARAQUAT 250 HERBICIDE
50430 AW SICEM SELECTIVE HERBICIDE
50500 TRANSIT 750 SG HERBICIDE
50151 BROADSTRIKE HERBICIDE
50640 NOT AVAILABLE
50739 CERENIA 160MG TABLETS FOR DOGS
50740 CERENIA 16MG TABLETS FOR DOGS
50741 CERENIA 60MG TABLETS FOR DOGS
50742 CERENIA 24MG TABLETS FOR DOGS
50743 CERENIA INJECTABLE SOLUTION
50923 MORTEIN NATURGARD FLY & MOSQUITO KILLER
50956 NOT AVAILABLE
50957 NOT AVAILABLE
51353 ROYAL MH-30 XTRA PLANT GROWTH REGULATOR
51372 COUNTRY DICAMBA M SELECTIVE HERBICIDE
51380 TITAN ALPHA DUO 100 INSECTICIDE
51463 NUFARM INVADER 600 HERBICIDE
51466 NOT AVAILABLE
51585
BACILLUS THURINGIENSIS SUBSP. KURSTAKI DELTA ENDOXOXIN AS PRODUCED BY CRYL1AC GENE AND IT'S CONTROLLING SEQUENCE AND THE BACILLUS THURINGIENSIS SUBSP. AIZAWI DELTA ENDOTOXIN AS PRODUCED BY CRY1F GENE
A change or correction has been made to the following summaries:
Application No. Product/Active Constituent Name
Other Notices - Application Summaries
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 Agricultural and Veterinary Chemicals Code Act 1994 25
APVMA CONTACT
For further information please contact:
Application Management and Enquiries Team (AME) Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4701 Fax: (02) 6210 4721
Other Notices - Application Summaries
Commonwealth of Australia Gazette No. APVMA 20, Tuesday, 26 October 2010 Agricultural and Veterinary Chemicals Code Act 1994 26
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. 19, 12 OCTOBER 2010
For use in agricultural and/or veterinary chemical products:
Common Name Approval Holder Manufacturer Site Approval No.Polydimethysiloxane DOW CORNING SOUTH SAGINAW ROAD
MIDLAND, MICHIGAN 48686 USA 64670
APVMA CONTACT
For further information please contact:
Application Management & Enquiries Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4701 Fax: (02) 6210 4721
Other Notices - Addendum to the Record of Approved Active Constituents