APVMA Gazette No. 25, 15 December 2020 · Web view100 g/kg chlorine dioxide (ClO 2) present as 200...
Transcript of APVMA Gazette No. 25, 15 December 2020 · Web view100 g/kg chlorine dioxide (ClO 2) present as 200...
Gazette Agricultural andVeterinary Chemicals
No. APVMA 25, Tuesday, 15 December 2020
Published by the Australian Pesticides and Veterinary Medicines Authority
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 2023
This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any
process without prior written permission from the Australian Pesticides and Veterinary Medicines Authority. Requests and
inquiries concerning reproduction and rights should be addressed to:
Assistant Director, Communications
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Email: [email protected]
Website: 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.
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For enquiries on the APVMA Gazette content, please refer to the individual APVMA contacts listed under each notice.
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
CONTENTS
Agricultural Chemical Products and Approved Labels.............................................................................................................
Veterinary Chemical Products and Approved Labels............................................................................................................
Approved Active Constituents................................................................................................................................................
Licensing of Veterinary Chemical Manufacturers..................................................................................................................
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Agricultural Chemical Products and Approved Labels
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of the registration in respect of the following products and has approved the label or varied the relevant particulars or conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.
1. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Application no.: 127392
Product name: Barmac Glyphosate 540 Herbicide
Active constituent/s: 540 g/L glyphosate present as the potassium salt
Applicant name: Amgrow Pty Ltd
Applicant ACN: 100 684 786
Summary of use: For the control of many annual and perennial weeds
Date of registration: 23 November 2020
Product registration no.:
90092
Label approval no.: 90092/127392
Application no.: 127479
Product name: Oracle EC Insecticide
Active constituent/s: 17 g/L emamectin present as emamectin benzoate
Applicant name: Adama Australia Pty Ltd
Applicant ACN: 050 328 973
Summary of use: For control or suppression of various insect pests in brassica vegetables, capsicum, grapes, lettuce, sweet corn and tomatoes
Date of registration: 23 November 2020
Product registration no.:
90104
Label approval no.: 90104/127479
Application no.: 127480
Product name: Warlock EC Insecticide
Active constituent/s: 17 g/L emamectin present as emamectin benzoate
Applicant name: Adama Australia Pty Ltd
Applicant ACN: 050 328 973
Summary of use: For control or suppression of various insect pests in canola, cotton and pulses
Date of registration: 23 November 2020
Product registration no.:
90105
Label approval no.: 90105/127480
Application no.: 124440
Product name: Surefire Spirotetramat 240 SC Insecticide
Active constituent/s: 240 g/L spirotetramat
Applicant name: PCT Holdings Pty Ltd
Applicant ACN: 099 023 962
Summary of use: For control of various insect pests in cotton and certain fruit and vegetable crops
Date of registration: 23 November 2020
Product registration no.:
89337
Label approval no.: 89337/124440
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 125285
Product name: Genfarm Gibberellic Acid 100 Growth Regulator
Active constituent/s: 100 g/L gibberellic acid
Applicant name: Nutrien Ag Solutions Limited
Applicant ACN: 008 743 217
Summary of use: To promote desirable harvest effects in certain varieties of grapes, citrus and prunes and to stimulate production of winter-dormant grass-pastures for high intensity grazing
Date of registration: 24 November 2020
Product registration no.:
89567
Label approval no.: 89567/125285
Application no.: 128609
Product name: Baysol® Snail And Slug Bait Iron
Active constituent/s: 60 g/kg iron EDTA complex
Applicant name: Wattleglen Projects Pty Ltd
Applicant ACN: 006 151 168
Summary of use: For use in control of snails and slugs in the home garden
Date of registration: 24 November 2020
Product registration no.:
90350
Label approval no.: 90350/128609
Application no.: 127157
Product name: Accensi 2,4-D Ester 680 Herbicide
Active constituent/s: 680 g/L 2,4-D present as the 2 ethylhexyl ester
Applicant name: Accensi Pty Ltd
Applicant ACN: 079 875 184
Summary of use: For selective control of various weeds in crops, pastures and non-agricultural areas
Date of registration: 25 November 2020
Product registration no.:
90035
Label approval no.: 90035/127157
Application no.: 127551
Product name: Barmac MCPA 750 Selective Herbicide
Active constituent/s: 750 g/L MCPA present as the dimethylamine salt
Applicant name: Amgrow Pty Ltd
Applicant ACN: 100 684 786
Summary of use: For the selective control of broadleaf weeds in cereals, linseed, oilseed poppies, pastures, rice, sugar cane and turf
Date of registration: 25 November 2020
Product registration no.:
90114
Label approval no.: 90114/127551
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 127548
Product name: Accensi Carbendazim 500 SC Fungicide
Active constituent/s: 500 g/L carbendazim
Applicant name: Accensi Pty Ltd
Applicant ACN: 079 875 184
Summary of use: For the control of fungal diseases in chickpeas, faba beans, lentils, vetch and macadamia nuts
Date of registration: 26 November 2020
Product registration no.:
90113
Label approval no.: 90113/127548
Application no.: 123573
Product name: Cerepin 100EC Selective Herbicide
Active constituent/s: 100 g/L pinoxaden, 25 g/L cloquintocet-mexyl
Applicant name: Shandong Rainbow International Co Ltd
Applicant ACN: N/A
Summary of use: For the control of key grass weeds and selective spray topping of wild oats in wheat and barley
Date of registration: 27 November 2020
Product registration no.:
89096
Label approval no.: 89096/123573
Application no.: 123137
Product name: Biovx Broad Spectrum Concentrated Water Soluble Powder (SP) Disinfectant
Active constituent/s: 450 g/kg potassium peroxymonosulphate triple salt, 150 g/kg sodium dodecyl benzene sulfonate, 15 g/kg sodium chloride
Applicant name: Mediralis Pty Ltd
Applicant ACN: 605 830 626
Summary of use: For use as a virucidal, bactericidal and fungicidal disinfectant for use in disinfecting industrial, agricultural and animal farming equipment, machinery and facilities
Date of registration: 3 December 2020
Product registration no.:
89005
Label approval no.: 89005/123137
Application no.: 127757
Product name: Weed Force Ninja Herbicide
Active constituent/s: 200 g/L triclopyr, 100 g/L picloram
Applicant name: Weed Force Pty Ltd
Applicant ACN: 602 207 152
Summary of use: For control of blackberry, gorse and harrisia cactus by foliage spray and unwanted timber by stem injection or cut stump/brush cutter application
Date of registration: 3 December 2020
Product registration no.:
90140
Label approval no.: 90140/127757
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 122683
Product name: Conquest Wingman 500 WG Herbicide
Active constituent/s: 500 g/kg flumioxazin
Applicant name: Conquest Crop Protection Pty Ltd
Applicant ACN: 098 814 932
Summary of use: For pre-plant knockdown of various weeds
Date of registration: 3 December 2020
Product registration no.:
88854
Label approval no.: 88854/122683
Application no.: 124630
Product name: Choice Katana 600 Herbicide
Active constituent/s: 600 g/L dichlorprop present as the potassium salt
Applicant name: Grow Choice Pty Ltd
Applicant ACN: 161 264 884
Summary of use: For the integrated control of all varieties of lantana, sicklepod, wild verbena, phyla weed (lippia, condamine couch), scotch/spear thistle, harrisia cactus, smart weed and galvanised burr
Date of registration: 4 December 2020
Product registration no.:
89401
Label approval no.: 89401/124630
Application no.: 123743
Product name: Conquest Preceed 850 WG Herbicide
Active constituent/s: 850 g/kg pyroxasulfone
Applicant name: Conquest Crop Protection Pty Ltd
Applicant ACN: 098 814 932
Summary of use: For the pre-emergence control of annual ryegrass, barley grass, annual phalaris, silver grass and toad rush and suppression of certain grass weeds in wheat (not durum wheat) and triticale
Date of registration: 4 December 2020
Product registration no.:
89148
Label approval no.: 89148/123743
Application no.: 126302
Product name: ExStinkt Pure H2O Tablet
Active constituent/s: 100 g/kg chlorine dioxide (ClO2) present as 200 g/kg sodium chlorite
Applicant name: Zychem Technologies Pty Ltd
Applicant ACN: 083 337 973
Summary of use: For control of bacteria and biofilm, and for proactive management of protozoa, including Cryptosporidium spp., in swimming pools
Date of registration: 4 December 2020
Product registration no.:
89891
Label approval no.: 89891/126302
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 127765
Product name: CropSure Hallotop 520 Herbicide
Active constituent/s: 520 g/L haloxyfop present as the haloxyfop-R-methyl ester
Applicant name: Cropsure Pty Ltd
Applicant ACN: 643 829 190
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: 4 December 2020
Product registration no.:
90144
Label approval no.: 90144/127765
Application no.: 127785
Product name: CropSure Parashot 250 Herbicide
Active constituent/s: 250 g/L paraquat present as paraquat dichloride
Applicant name: CropSure Pty Ltd
Applicant ACN: 643 829 190
Summary of use: For the control of a wide range of grasses and broadleaf weeds
Date of registration: 4 December 2020
Product registration no.:
90155
Label approval no.: 90155/127785
Application no.: 127707
Product name: Cropsure Slammer 400 EC Herbicide
Active constituent/s: 400 g/L carfentrazone-ethyl
Applicant name: Cropsure Pty Ltd
Applicant ACN: 643 829 190
Summary of use: For improvement in the control of marshmallow and certain other broadleaf weeds prior to establishment of broadacre crops, fallows or forest plantations, in commercial, industrial and public service areas, and around agricultural buildings and yards, in tree fruits, nuts and grapevines in tank mixture with knockdown herbicides; for the control of marshmallow and annual nettles in grass pastures and rough grass/turf areas; and control of volunteer cotton seedlings and desiccation of cotton re-growth
Date of registration: 4 December 2020
Product registration no.: 90129
Label approval no.: 90129/127707
2. VARIATIONS OF REGISTRATION
Application no.: 128683
Product name: Titan Immense Herbicide
Active constituent/s: 33 g/L imazamox present as the ammonium salt, 15 g/L imazapyr present as the ammonium salt
Applicant name: Titan Ag Pty Ltd
Applicant ACN: 122 081 574
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Titan Imazamox 30 + Imazapyr 15 Herbicide’ to ‘Titan Immense Herbicide’
Date of variation: 11 November 2020
Product registration no.:
88704
Label approval no.: 88704/128683
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 128744
Product name: EDN Fumigant
Active constituent/s: 1,000 g/kg ethanedinitrile
Applicant name: Draslovka Services Pty Ltd
Applicant ACN: 609 536 763
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘EDN Fumigas’ to ‘EDN Fumigant’
Date of variation: 18 November 2020
Product registration no.:
60096
Label approval no.: 60096/128744
Application no.: 128778
Product name: Sequence 360 Herbicide
Active constituent/s: 360 g/L clethodim
Applicant name: Nufarm Australia Limited
Applicant ACN: 004 377 780
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Havoc Plus 360 Herbicide’ to ‘Sequence 360 Herbicide’
Date of variation: 19 November 2020
Product registration no.:
90052
Label approval no.: 90052/128778
Application no.: 126633
Product name: Nufarm Triflurx Selective Herbicide
Active constituent/s: 480 g/L trifluralin
Applicant name: Nufarm Australia Limited
Applicant ACN: 004 377 780
Summary of variation:
To add a use in wheat and to add uses under the APVMA Permit to Label Project
Date of variation: 24 November 2020
Product registration no.:
56421
Label approval no.: 56421/126633
Application no.: 126072
Product name: Suscon Maxi Intel Soil Insecticide
Active constituent/s: 50 g/kg imidacloprid
Applicant name: Nufarm Australia Limited
Applicant ACN: 004 377 780
Summary of variation:
To accommodate modern dual row planting systems and to simplify the directions for use table
Date of variation: 24 November 2020
Product registration no.:
70098
Label approval no.: 70098/126072
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 127502
Product name: Kenso Agcare Rebuke 430 SC Fungicide
Active constituent/s: 430 g/L tebuconazole
Applicant name: Kenso Corporation (M) Sdn Bhd
Applicant ACN: N/A
Summary of variation:
To add uses in duboisia, oil tea tree, anise myrtle, lemon myrtle, non-food producing plants and vegetation, beetroot, beetroot leaves, chicory, endive, radish, silverbeet, spinach, carrots, mung beans, faba beans, broad beans, soya beans, walnuts and garlic
Date of variation: 25 November 2020
Product registration no.:
59159
Label approval no.: 59159/127502
Application no.: 127477
Product name: Storm 960 Herbicide
Active constituent/s: 960 g/L S-metolachlor
Applicant name: Sunrise Crop Science Co Ltd
Applicant ACN: N/A
Summary of variation:
To vary the label to add the uses for various weeds in rhubarb, various broadleaf and grass weeds in brassica leafy vegetables, multiple pests in mustard, various broadleaf and grass weeds in spinach, silverbeet, spring onions, shallots, green beans and navy beans, weeds in culinary herbs
Date of variation: 25 November 2020
Product registration no.:
86836
Label approval no.: 86836/127477
Application no.: 127342
Product name: Octave WP Fungicide
Active constituent/s: 462 g/kg prochloraz as the manganese chloride complex
Applicant name: FMC Australasia Pty Ltd
Applicant ACN: 095 326 891
Summary of variation:
To add use in additional jurisdictions for non-fruiting strawberry runners
Date of variation: 26 November 2020
Product registration no.:
30485
Label approval no.: 30485/127342
Application no.: 126104
Product name: Clearout Plus IGR Aerosol Insecticide
Active constituent/s: 0.5 g/kg fipronil, 0.15 g/kg pyriproxyfen
Applicant name: Sherwood Chemicals Australasia Pty Ltd
Applicant ACN: 136 993 630
Summary of variation:
To include control of house flies and to change the product name
Date of variation: 26 November 2020
Product registration no.:
88298
Label approval no.: 88298/126104
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 127549
Product name: Tebby 430 Fungicide
Active constituent/s: 430 g/L tebuconazole
Applicant name: Crop Culture Pty Ltd
Applicant ACN: 142 860 473
Summary of variation:
To add control of various diseases in faba beans, broad beans, duboisia, mung bean, riberries, anise myrtle, lemon myrtle, non-food producing plants and vegetation, garlic, tea tree oil, beetroot, chicory, endive, radish, silverbeet, spinach, carrots, soya beans and walnuts
Date of variation: 26 November 2020
Product registration no.:
82030
Label approval no.: 82030/127549
Application no.: 125459
Product name: Kelpie Promix 550 GLY Herbicide
Active constituent/s: 550 g/L glyphosate present as the potassium salt and monoethalamine salts
Applicant name: Sinochem International Australia Pty Ltd
Applicant ACN: 160 164 616
Summary of variation:
To include new fallow, pre-and post-harvest use and general weed control use situations
Date of variation: 26 November 2020
Product registration no.:
88261
Label approval no.: 88261/125459
Application no.: 127550
Product name: Imtrade Trifluralin 480 EC Herbicide
Active constituent/s: 480 g/L trifluralin
Applicant name: Imtrade Australia Pty Ltd
Applicant ACN: 090 151 134
Summary of variation:
To add the uses for various broad leaf and grass weeds in chillies, paprika and eggplant, multiple pests in mustard, wintergrass in parsnips, pests and diseases (Cercospora leaf spot) in duboisia, weeds in swedes and turnips, selected grass weeds in quinoa, various pests and diseases in tea tree oil, various weeds in industrial hemp
Date of variation: 27 November 2020
Product registration no.:
63455
Label approval no.: 63455/127550
Application no.: 127633
Product name: Fosetyl 800 Fungicide
Active constituent/s: 800 g/kg fosetyl-aluminium
Applicant name: Turf Culture Pty Ltd
Applicant ACN: 117 986 615
Summary of variation:
To extend the use to include apples, peaches, avocados, pineapples and include a 100 sq metre rate for turf
Date of variation: 27 November 2020
Product registration no.:
69562
Label approval no.: 69562/127633
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 127651
Product name: Maxunitech Progress 420 EC Fungicide
Active constituent/s: 210 g/L prothioconazole, 210 g/L tebuconazole
Applicant name: Max (Rudong) Chemicals Co Ltd
Applicant ACN: N/A
Summary of variation:
To add use in mustard
Date of variation: 27 November 2020
Product registration no.:
88389
Label approval no.: 88389/127651
Application no.: 128748
Product name: Vitra 400 WG Fungicide
Active constituent/s: 400 g/kg copper (Cu) present as cupric hydroxide
Applicant name: Industrias Quimicas Del Valles SA
Applicant ACN: N/A
Summary of variation:
To update product label in line with current Ag Labelling Code and FAISD Handbook guidelines
Date of variation: 27 November 2020
Product registration no.:
65926
Label approval no.: 65926/128748
Application no.: 127066
Product name: Family Protection Aerogard Body Max 40% Deet Our Highest Strength Protection 12 Hours Protection Against Mosquitoes Long Lasting Protection Personal Insect Repellent
Active constituent/s: 400 g/kg diethyltoluamide
Applicant name: RB (Hygiene Home) Australia Pty Ltd
Applicant ACN: 629 549 506
Summary of variation:
To change the product name
Date of variation: 30 November 2020
Product registration no.:
69786
Label approval no.: 69786/127066
Application no.: 127652
Product name: Nufarm Spin Flo Systemic Fungicide
Active constituent/s: 500 g/L carbendazim
Applicant name: Nufarm Australia Limited
Applicant ACN: 004 377 780
Summary of variation:
To add use in field grown garlic to control botrytis
Date of variation: 30 November 2020
Product registration no.:
59815
Label approval no.: 59815/127652
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 127343
Product name: Expedite Full Insecticide
Active constituent/s: 500 g/kg sulfoxaflor
Applicant name: Dow Agrosciences Australia Limited
Applicant ACN: 003 771 659
Summary of variation:
To add use situations in tree nuts; pack sizes; and to include required restraints
Date of variation: 30 November 2020
Product registration no.:
65464
Label approval no.: 65464/127343
Application no.: 127556
Product name: Kenso Agcare Ken-Ester LV 680 Selective Herbicide
Active constituent/s: 680 g/L 2,4-D present as the ethylhexyl ester
Applicant name: Kenso Corporation (M) Sdn Bhd
Applicant ACN: N/A
Summary of variation:
To amend the product label in line with the 2,4-D reconsideration final regulatory decision
Date of variation: 1 December 2020
Product registration no.:
65224
Label approval no.: 65224/127556
Application no.: 127635
Product name: Kenso Agcare Ken-Amine 625 Selective Herbicide
Active constituent/s: 625 g/L 2,4-D present as the dimethylamine and diethanolamine salts
Applicant name: Kenso Corporation (M) Sdn Bhd
Applicant ACN: N/A
Summary of variation:
To amend the product label in line with the 2,4-D reconsideration final regulatory decision and add the uses for control of llcerne in fallow, pimelea in various situations and various weeds in oil tea tree and hardwood and softwood plantations
Date of variation: 2 December 2020
Product registration no.:
56339
Label approval no.: 56339/127635
Application no.: 128105
Product name: Accensi 2,4-D Low Odour 500 Selective Herbicide
Active constituent/s: 500 g/L 2,4-D present as the diethanolamine salt
Applicant name: Accensi Pty Ltd
Applicant ACN: 079 875 184
Summary of variation:
To amend the product label in line with the 2,4-D reconsideration final regulatory decision and add the uses for control of broadleaf weeds in tea tree plantations
Date of variation: 2 December 2020
Product registration no.:
68535
Label approval no.: 68535/128105
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 127664
Product name: Imtrade Pirimicarb 500 WG Aphicide
Active constituent/s: 500 g/kg pirimicarb (an anticholinesterase compound)
Applicant name: Imtrade Australia Pty Ltd
Applicant ACN: 090 151 134
Summary of variation:
To add the uses for multiple pests in mustard, various aphid species in strawberries, cowpea aphid and soybean aphid in adzuki bean, mung bean and soybean, bean aphid in faba bean, broad bean and vetches, various aphids in sweet potato, spring onion, green peach aphid in blackberries and aphids in nursery stock
Date of variation: 2 December 2020
Product registration no.:
60138
Label approval no.: 60138/127664
Application no.: 127715
Product name: Accensi Tri-Max 480 EC Herbicide
Active constituent/s: 480 g/L trifluralin
Applicant name: Accensi Pty Ltd
Applicant ACN: 079 875 184
Summary of variation:
To add control of various broad leaf and grass weeds in chillies, paprika and eggplant; control of multiple pests in mustard; weeds in parsnips; pests, diseases and Cercospora leaf spot in duboisia; weeds in swedes and turnips; selected grass weeds in quinoa; various pests and diseases in tee tree oil, and various weeds in industrial hemp
Date of variation: 2 December 2020
Product registration no.:
81536
Label approval no.: 81536/127715
Application no.: 127752
Product name: Orius 430 SC Fungicide
Active constituent/s: 430 g/L tebuconazole
Applicant name: Adama Australia Pty Ltd
Applicant ACN: 050 328 973
Summary of variation:
To add uses in duboisia, oil tea tree, anise myrtle, lemon myrtle, non-food producing plants and vegetation, beetroot, beetroot leaves, chicory, endive, radish, silverbeet, spinach, carrots, mung beans, faba beans, broad beans, soya beans, walnuts and garlic
Date of variation: 2 December 2020
Product registration no.:
58773
Label approval no.: 58773/127752
Application no.: 127503
Product name: Grochem Dusting Sulphur Fungicide/Miticide
Active constituent/s: 930 g/kg sulphur (S) present as powdered sulphur
Applicant name: Grochem Australia Pty Ltd
Applicant ACN: 169 400 033
Summary of variation:
To include use in Tasmania for the control of powdery mildew in grapes, pumpkins and marrows
Date of variation: 3 December 2020
Product registration no.:
67918
Label approval no.: 67918/127503
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 127555
Product name: Nova Amine 625 Herbicide
Active constituent/s: 625 g/L 2,4-D present as the dimethylamine and diethanolamine salts
Applicant name: Sunrise Crop Science Co Ltd
Applicant ACN: N/A
Summary of variation:
To amend the product label in line with the 2,4-D reconsideration final regulatory decision and add uses for the control of lucerne in fallow, broadleaf and woody weeds in hardwood and softwood plantations, Pimelea spp. in agricultural non-crop areas, commercial and industrial areas, pastures and rights of-way and various weeds in oil tea tree
Date of variation: 3 December 2020
Product registration no.:
87542
Label approval no.: 87542/127555
Application no.: 127665
Product name: Accensi Metolachlor 720 Herbicide
Active constituent/s: 720 g/L metolachlor
Applicant name: Accensi Pty Ltd
Applicant ACN: 079 875 184
Summary of variation:
To add use for multiple pests in mustard, various broadleaf and grass weeds in spinach, silver beet, spring onions, shallots, green beans and navy beans, certain annual grasses and broadleaf weeds in adzuki beans and mung beans, and various pests and diseases in tea tree oil
Date of variation: 3 December 2020
Product registration no.:
63171
Label approval no.: 63171/127665
Application no.: 127371
Product name: Agro-Gold 1-HR Weed Killer RTU
Active constituent/s: 20.5 g/L nonanoic acid, 16 g/L glyphosate present as the ammonium salt
Applicant name: Agro-Alliance (Australia) Pty Ltd
Applicant ACN: 130 864 603
Summary of variation:
To update the safety directions and first aid instructions
Date of variation: 4 December 2020
Product registration no.:
86305
Label approval no.: 86305/127371
3. LABEL APPROVAL
Application no.: 128162
Product name: Lo-Chlor Spa Sanitiser
Active constituent/s: 504 g/kg available chlorine present as sodium dichloroisocyanurate
Applicant name: M I International Pty Ltd
Applicant ACN: 002 869 089
Summary of variation:
To approve a new label for the product 'Lo-Chlor Spa Sanitiser' with the label name 'Iluka Spa Purifier'
Date of variation: 3 December 2020
Product registration no.:
85547
Label approval no.: 85547/128162
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Veterinary Chemical Products and Approved Labels
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of the registration in respect of the following products and has approved the label or varied the relevant particulars or conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.
1. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS
Application no.: 122696
Product name: Websters 6 In 1 B12 & Se Vaccine
Active constituent/s: Contains aluminium adjuvanted toxoid and cellular antigen from 5.0 IU/mL Clostridium perfringens type D, 1.0 U/mL Corynebacterium pseudotuberculosis (ovis), 3.5 IU/mL Cl. novyi type B, 2.5 IU/mL Cl. tetani, 2.5 IU/mL Cl. septicum, ≥ 0.3% PCV/ mL Cl. chauvoei, 2 mg/mL vitamin B12 (hydroxocobalamin acetate) and 1 mg/mL selenium as sodium selenate
Applicant name: Virbac (Australia) Pty Ltd
Applicant ACN: 003 268 871
Summary of use: For the prevention of cheesy gland (C. pseudotuberculosis), pulpy kidney (Cl. perfringens type D), black disease (Cl. novyi type B), malignant oedema (Cl. septicum), tetanus (Cl. tetani) and blackleg (Cl. chauvoei) in sheep and lambs and the prevention of selenium responsive conditions and for the treatment and prevention of vitamin B12 deficiency in sheep
Date of registration: 24 November 2020
Product registration no.:
88862
Label approval no.: 88862/122696
Application no.: 122698
Product name: Websters 6 In 1 B12 Vaccine
Active constituent/s: Contains aluminium adjuvanted toxoid and cellular antigen from 5.0 IU/mL Clostridium perfringens type D, 3.5 IU/mL Cl. novyi type B, 2.5 IU/mL Cl. tetani, 2.5 IU/mL Cl. septicum, 1.0 U/mL Corynebacterium pseudotuberculosis (ovis), ≥ 0.3% PCV/mL Cl. chauvoei and 2 mg/mL vitamin B12 (hydroxocobalamin acetate)
Applicant name: Virbac (Australia) Pty Ltd
Applicant ACN: 003 268 871
Summary of use: For the prevention of cheesy gland (C. pseudotuberculosis), pulpy kidney (Cl. perfringens type D), black disease (Cl. novyi type B), malignant oedema (Cl. septicum), tetanus (Cl. tetani) and blackleg (Cl. chauvoei) in sheep and lambs and for treatment and prevention of vitamin B12 deficiency in sheep
Date of registration: 24 November 2020
Product registration no.:
88864
Label approval no.: 88864/122698
Application no.: 120624
Product name: Vanguard B-Oral Live Vaccine For Dogs
Active constituent/s: Live attenuated Bordetella bronchiseptica ≥ 1.4 x 10^8 CFU per dose
Applicant name: Zoetis Australia Pty Ltd
Applicant ACN: 156 476 425
Summary of use: For the active immunisation of healthy dogs and puppies from eight weeks of age to reduce clinical signs and nasal shedding caused by Bordetella bronchiseptica
Date of registration: 24 November 2020
Product registration no.:
88237
Label approval no.: 88237/120624
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 127053
Product name: Barbervax Barber's Pole Worm Vaccine
Active constituent/s: minimum 5 μg/mL purified Haemonchus contortus antigen
Applicant name: Wormvax Australia Pty Ltd
Applicant ACN: 162 279 987
Summary of use: For use as an aid in reduction of disease caused by Barber's Pole worm in lambs, yearlings and ewes
Date of registration: 25 November 2020
Product registration no.:
90013
Label approval no.: 90013/127053
Application no.: 127806
Product name: [Wagg & Purr] Enrofloxacin Injection
Active constituent/s: 50 mg/mL enrofloxacin
Applicant name: Avet Health Pty Ltd
Applicant ACN: 616 838 101
Summary of use: For the treatment of diseases caused by susceptible bacterial pathogens
Date of registration: 25 November 2020
Product registration no.:
90159
Label approval no.: 90159/127806
Application no.: 126209
Product name: CarproJect 50mg/mL Injection
Active constituent/s: 50 mg/mL carprofen
Applicant name: Probus Pharmaceuticals Pty Ltd
Applicant ACN: 638 193 674
Summary of use: For use as a non-steroidal, anti-inflammatory and analgesic in dogs, cats and horses
Date of registration: 30 November 2020
Product registration no.:
89833
Label approval no.: 89833/126209
Application no.: 126303
Product name: Jurox TMPS Antibacterial Suspension For Injection
Active constituent/s: 400 mg/mL sulfadiazine, 80 mg/mL trimethoprim
Applicant name: Jurox Pty Ltd
Applicant ACN: 000 932 230
Summary of use: For the treatment of infections caused by organisms sensitive to trimethoprim and sulfadiazine in cattle, sheep, pigs and horses
Date of registration: 2 December 2020
Product registration no.:
89892
Label approval no.: 89892/126303
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 127552
Product name: Covine Duomate Tick Development Inhibitor And Broad Spectrum Pour-On
Active constituent/s: 15 g/L fluazuron, 5 g/L ivermectin
Applicant name: Nutrien Ag Solutions Limited
Applicant ACN: 008 743 217
Summary of use: For control of fluazuron susceptible cattle tick, Rhipicephalus microplus, including strains resistant to organophosphates, synthetic pyre throids and amidines, on beef cattle and for the treatment and control of ivermectin sensitive internal and external parasites of beef cattle
Date of registration: 2 December 2020
Product registration no.:
90115
Label approval no.: 90115/127552
Application no.: 126328
Product name: Jurox Imida-Moxi Spot-On For Dogs 4 – 10 kg
Active constituent/s: 100 g/L imidacloprid, 25 g/L moxidectin
Applicant name: Jurox Pty Ltd
Applicant ACN: 000 932 230
Summary of use: For use in dogs for treatment of fleas, prevention of heartworm, treatment and control of intestinal worms and larvae, mites and lice
Date of registration: 3 December 2020
Product registration no.:
89911
Label approval no.: 89911/126328
Application no.: 126306
Product name: Jurox TMPS Antibacterial Solution For Injection
Active constituent/s: 200 mg/mL sulfadoxine, 40 mg/mL trimethoprim
Applicant name: Jurox Pty Ltd
Applicant ACN: 000 932 230
Summary of use: For the treatment of infections caused by organisms sensitive to trimethoprim and sulfadoxine in cattle, sheep, pigs, horses, cats and dogs
Date of registration: 3 December 2020
Product registration no.:
89895
Label approval no.: 89895/126306
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 127798
Product name: Randlab Tulathromycin Injection
Active constituent/s: 100 mg/mL tulathromycin
Applicant name: Randlab Australia Pty Ltd
Applicant ACN: 114 948 837
Summary of use: For the treatment of tulathromycin sensitive bacterial respiratory infections in pigs and in cattle, including dairy heifers up to the point of first mating
Date of registration: 3 December 2020
Product registration no.:
90158
Label approval no.: 90158/127798
2. VARIATIONS OF REGISTRATION
Application no.: 122309
Product name: Coopers Nilverm LV Oral Wormer
Active constituent/s: 80 g/L levamisole hydrochloride equivalent to 68 g/L levamisole
Applicant name: Intervet Australia Pty Ltd
Applicant ACN: 008 467 034
Summary of variation:
To add an additional pack size, extension of use to pigs and poultry and to change the product name
Date of variation: 24 November 2020
Product registration no.:
36152
Label approval no.: 36152/122309
Application no.: 125218
Product name: Hideject Vitamin A, D3 And E Injection
Active constituent/s: 25 mg/mL (25 IU/mL) vitamin E = di-alpha tocopherol acetate, 18 mg/mL (60,000 IU/mL) vitamin A as palmitate = retinyl palmitate, 12.5 mg/mL (500,000 IU/mL) vitamin D3 = cholecalciferol
Applicant name: Elanco Australasia Pty Ltd
Applicant ACN: 076 745 198
Summary of variation:
To update the in-use shelf life statement for the product
Date of variation: 30 November 2020
Product registration no.:
35995
Label approval no.: 35995/125218
Application no.: 127655
Product name: Zolexx Paste For Horses
Active constituent/s: 370 mg/g omeprazole
Applicant name: Abbey Laboratories Pty Ltd
Applicant ACN: 156 000 430
Summary of variation:
To update pack sizes by including additional net contents 28 x 6.15 g, 33 g and 6 x 33 g
Date of variation: 3 December 2020
Product registration no.:
63080
Label approval no.: 63080/127655
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 127952
Product name: Pulse-8 Liquid Vitamin Supplement For Performance Horses
Active constituent/s: Part A: 3.33 mg/mL thiamine hydrochloride (vitamin B1), 1.67 mg/mL pyridoxine hydrochloride (vitamin B6), 0.5 mg/mL folic acid. Part B: 13.33 mg/mL nicotinamide (vitamin B3), 3.33 mg/mL (3.33 IU) dl-alpha tocopheryl acetate (vitamin E), 3.33 mg/mL dexpanthenol (vitamin B5), 1.67 mg/mL riboflavine sodium phosphate (vitamin B2), 1 mg/mL (1,000 IU) retinyl palmitate (vitamin A), 0.1 mg/mL (100 IU) cholecalciferol (vitamin D3), 6.67 μg/mL cyanocobalamin (vitamin B12)
Applicant name: Virbac (Australia) Pty Ltd
Applicant ACN: 003 268 871
Summary of variation:
To update general directions statement of the label
Date of variation: 3 December 2020
Product registration no.:
38796
Label approval no.: 38796/127952
Application no.: 122584
Product name: Methone Injection
Active constituent/s: 10 mg/mL methadone hydrochloride
Applicant name: Ceva Animal Health Pty Ltd
Applicant ACN: 002 692 426
Summary of variation:
To amend the in-use shelf life statement
Date of variation: 3 December 2020
Product registration no.:
41455
Label approval no.: 41455/122584
3. VARIATION OF LABEL APPROVAL
Application no.: 127294
Product name: Sentinel Spectrum Tasty Chews For Very Small Dogs
Active constituent/s: 46 mg lufenuron, 22.8 mg praziquantel, 2.3 mg milbemycin oxime per chew
Applicant name: Elanco Australasia Pty Ltd
Applicant ACN: 076 745 198
Summary of variation: To align the label to the Veterinary Labelling Code, amend claim statement and remove reference to previous holder and a product that is not in the market
Date of variation: 24 November 2020
Product registration no.: 62393
Label approval no.: 62393/127294
Application no.: 127292
Product name: Sentinel Spectrum Tasty Chews For Small Dogs
Active constituent/s: 115 mg lufenuron, 57 mg praziquantel, 5.75 mg milbemycin oxime per chew
Applicant name: Elanco Australasia Pty Ltd
Applicant ACN: 076 745 198
Summary of variation:
To align the label to the Veterinary Labelling Code, amend claim statement and remove reference to previous holder and a product that is not in the market
Date of variation: 24 November 2020
Product registration no.:
62392
Label approval no.: 62392/127292
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 127281
Product name: Sentinel Spectrum Tasty Chews For Medium Dogs
Active constituent/s: 230 mg lufenuron, 114 mg praziquantel, 11.5 mg milbemycin oxime per chew
Applicant name: Elanco Australasia Pty Ltd
Applicant ACN: 076 745 198
Summary of variation:
To align the label to the Veterinary Labelling Code, amend claim statement and remove reference to previous holder and a product that is not in the market
Date of variation: 24 November 2020
Product registration no.:
62391
Label approval no.: 62391/127281
Application no.: 127293
Product name: Sentinel Spectrum Tasty Chews For Large Dogs
Active constituent/s: 460 mg lufenuron, 228 mg praziquantel, 23 mg milbemycin oxime per chew
Applicant name: Elanco Australasia Pty Ltd
Applicant ACN: 076 745 198
Summary of variation:
To align the label to the Veterinary Labelling Code, amend claim statement and remove reference to previous holder and a product that is not in the market
Date of variation: 24 November 2020
Product registration no.:
62390
Label approval no.: 62390/127293
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Approved Active Constituents
Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has approved or varied the relevant particulars or conditions of the approval of the following active constituents, with effect from the dates shown.
1. ACTIVE CONSTITUENT
Application no.: 125128
Active constituent/s:
Dicyclanil
Applicant name: Elanco Australasia Pty Ltd
Applicant ACN: 076 745 198
Summary of use: For use in veterinary chemical products
Date of approval: 24 November 2020
Approval no.: 89521
Application no.: 120947
Active constituent/s:
Aclonifen
Applicant name: Bayer Cropscience Pty Ltd
Applicant ACN: 000 226 022
Summary of use: For use in agricultural chemical products
Date of approval: 24 November 2020
Approval no.: 88338
Application no.: 127626
Active constituent/s:
H. contortus integral membrane glycoproteins
Applicant name: Wormvax Australia Pty Ltd
Applicant ACN: 162 279 987
Summary of use: For use in veterinary chemical products
Date of approval: 24 November 2020
Approval no.: 90117
Application no.: 123212
Active constituent/s:
Albendazole oxide
Applicant name: Abbey Laboratories Pty Ltd
Applicant ACN: 156 000 430
Summary of use: For use in veterinary chemical products
Date of approval: 26 November 2020
Approval no.: 89023
Application no.: 125296
Active constituent/s:
Sulfoxaflor
Applicant name: Dow Agrosciences Australia Limited
Applicant ACN: 003 771 659
Summary of use: For use in agricultural chemical products
Date of approval: 2 December 2020
Approval no.: 89571
Approved Active Constituents
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 124469
Active constituent/s:
S-lactic acid
Applicant name: Virbac (Australia) Pty Ltd
Applicant ACN: 003 268 871
Summary of use: For use in veterinary chemical products
Date of approval: 2 December 2020
Approval no.: 89351
Application no.: 126479
Active constituent/s:
Lufenuron
Applicant name: Ferrari Animal Health Pty Ltd
Applicant ACN: 162 206 671
Summary of use: For use in veterinary chemical products
Date of approval: 2 December 2020
Approval no.: 89952
Application no.: 126518
Active constituent/s:
Milbemycin oxime
Applicant name: Ferrari Animal Health Pty Ltd
Applicant ACN: 162 206 671
Summary of use: For use in veterinary chemical products
Date of approval: 2 December 2020
Approval no.: 89960
Application no.: 126521
Active constituent/s:
Oxytetracycline dihydrate
Applicant name: Abbey Laboratories Pty Ltd
Applicant ACN: 156 000 430
Summary of use: For use in veterinary chemical products
Date of approval: 2 December 2020
Approval no.: 89962
Application no.: 123576
Active constituent/s:
Prothioconazole
Applicant name: Trustchem Co Ltd
Applicant ACN: N/A
Summary of use: For use in agricultural chemical products
Date of approval: 3 December 2020
Approval no.: 89098
Application no.: 126028
Active constituent/s:
Meloxicam
Applicant name: Chanelle Pharmaceuticals Manufacturing Ltd
Applicant ACN: N/A
Summary of use: For use in veterinary chemical product s
Date of approval: 4 December 2020
Approval no.: 89764
Approved Active Constituents
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
2. VARIATIONS OF ACTIVE CONSTITUENT
Application no.: 126299
Active constituent/s:
Triclabendazole
Applicant name: Boehringer Ingelheim Animal Health Australia Pty Ltd
Applicant ACN: 071 187 285
Summary of variation:
Variation of relevant particulars or conditions of an approved active constituent
Date of variation: 26 November 2020
Approval no.: 81937
Application no.: 125219
Active constituent/s:
Moxidectin
Applicant name: Boehringer Ingelheim Animal Health Australia Pty Ltd
Applicant ACN: 071 187 285
Summary of variation:
Variation of relevant particulars or conditions of an approved active constituent
Date of variation: 30 November 2020
Approval no.: 82193
Application no.: 125773
Active constituent/s:
Silver sulfadiazine
Applicant name: Elanco Australasia Pty Ltd
Applicant ACN: 076 745 198
Summary of variation:
Variation of relevant particulars or conditions of an approved active constituent
Date of variation: 30 November 2020
Approval no.: 56281
Application no.: 124847
Active constituent/s:
Flumethrin
Applicant name: Elanco Australasia Pty Ltd
Applicant ACN: 076 745 198
Summary of variation:
Variation of relevant particulars or conditions of an approved active constituent
Date of variation: 30 November 2020
Approval no.: 62446
Application no.: 125870
Active constituent/s:
Moxidectin
Applicant name: Elanco Australasia Pty Ltd
Applicant ACN: 076 745 198
Summary of variation:
Variation of relevant particulars or conditions of an approved active constituent
Date of variation: 2 December 2020
Approval no.: 81957
Approved Active Constituents
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Licensing of Veterinary Chemical Manufacturers
Pursuant to Part 8 of the Agricultural and Veterinary Chemicals Code (Agvet Code), 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.
1. NEW LICENCES
The APVMA has issued the following licences under subsection 123(1) of the Agvet Code:
Durablend Pty Ltd Licence number: 4113
ACN: 094 764 315
6 Coronation Avenue
Kings Park NSW 2148
Product types:* Category 4 – Powders
Steps of manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, sachet packaging, analysis and testing (physical), storage and release for supply.
Licence issued: 30 October 2020
Endeavour Animal Health Pty Ltd
Licence number: 2265
ACN: 632 235 646
657 Sandy Creek Road
Quorrobolong NSW 2325
Product types:* Category 2 – Pastes Category 4 – Powders
Steps of manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, storage, packaging, labelling, release for supply.
Licence issued: 18 August 2020
BJP Laboratories Pty Ltd Licence number: 4112
ACN: 132 975 412
2 Alloy Street
Yatala QLD 4207
Product types:* Category 4 – Hard shell
Steps of manufacture: Quality assurance (QA) of raw materials, formulation including blending, dry milling, wet milling, granulation, filling, packaging, labelling, repackaging (primary), relabelling (primary), sachet packaging (primary), tableting, tablet coating, capsule filling from bulk, analysis and testing (physical), and release for supply.
Licence issued: 1 September 2020
* Category 1: Immunobiologicals and sterile veterinary preparationsCategory 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplementsCategory 3: EctoparasiticidesCategory 4: Premixes and supplementsCategory 5: ExemptCategory 6: Single-step manufacturer
Licensing of Veterinary Chemical Manufacturers
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
The State of NSW Department Of Industry Trading Under The Business Name Of Department Of Primary Industries (Elizabeth Macarthur Agricultural Institute)
Licence number: 1120
ACN: 20 770 707 468
Woodbridge Road
Menangle NSW 2568
Product types:* Category 1 – Immunobiologicals
Steps of manufacture: Quality assurance (QA) of raw materials, management and immunisation of donor animals, virus cultivation, microbiological reduction treatment (chemical), analysis and testing (physical, microbiological, immunological, other testing – identity, haemagluttination, safety), packaging, labelling, release from manufacture (partial release) and storage.
Licence issued: 25 September 2020
Ferngrove Pharmaceutical Australia Pty Ltd
Licence number: 2270
ACN: 154 645 762
5 Ferngrove Place
South Granville NSW 2142
Product types:* Category 2 – Ointment, gel and cream Category 4 – Tablets, capsules (hard shell and soft), liquid, powder,
granules
Steps of manufacture: Quality assurance (QA) of raw materials, dry milling, granulation, filling, packaging, labelling, blister packaging, sachet packaging, tableting, tablet coating, capsule filling from bulk, analysis and testing (physical and chemical), storage and release for supply.
Licence issued: 27 November 2020
Padula Serums Pty Ltd Licence number: 1123
ACN: 167 348 610
100 Bosworth Road
Bairnsdale Vic 3875
Product types:* Category 1 – Immunobiologicals and sterile products for injection
Steps of manufacture: Quality assurance (QA) of raw materials, plasma collection, management and immunisation of donor animals, formulation including blending, aseptic filling, analysis and testing (physical, chemical, endotoxin, microbiological, sterility, serological and immunological), sterilisation (filtration), packaging, labelling, storage, release from manufacture only (partial release), release for supply.
Licence issued: 7 August 2020
* Category 1: Immunobiologicals and sterile veterinary preparationsCategory 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplementsCategory 3: EctoparasiticidesCategory 4: Premixes and supplementsCategory 5: ExemptCategory 6: Single-step manufacturer
Licensing of Veterinary Chemical Manufacturers
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Eurofins Chemical Analysis Pty Ltd
Licence number: 6233
ACN: 114 804 572
6 Monterey Road
Dandenong South Vic 3175
Product types:* Category 6 – All dosage forms
Steps of manufacture: Analysis and testing (physical, chemical, microbiological, and endotoxin).
Licence issued: 11 September 2020
Delta Laboratories Pty Ltd Licence number: 6234
ACN: 050 324 742
9 Chivers Road
Somersby NSW 2250
Product types:* Category 6 – All dosage forms
Steps of manufacture: Quality assurance (QA) of raw materials, sampling, dispensing, secondary packaging, secondary labelling, analysis and testing (physical and chemical), and storage.
Licence issued: 24 July 2020
Nutrien Ag Solutions Limited Licence number: 6235
ACN: 008 743 217
Level 5, Building A, 26 Talavera Road, Macquarie Park NSW 2113
Product types:* Category 6 – All dosage forms
Steps of manufacture: Release for supply
Licence issued: 11 September 2020
2. CHANGES TO EXISTING LICENCES
The APVMA has issued the following licences under subsection 123(1) of the Agvet Code:
Verita Pharma Pty Ltd Licence number: 2250
ACN: 604 520 532
Lot 8, 10 and 11 (SP92206)
2 Endeavour Road
Caringbah NSW 2229
Product types: *
Category 2 – Pastes, powders, creams and ointments
Category 3 – Premixes – powder, supplements – powder
Steps of manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, analysis and testing (chemical, physical), storage, and release for supply.
Amended licence issued: 17 November 2020
* Category 1: Immunobiologicals and sterile veterinary preparationsCategory 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplementsCategory 3: EctoparasiticidesCategory 4: Premixes and supplementsCategory 5: ExemptCategory 6: Single-step manufacturer
Licensing of Veterinary Chemical Manufacturers
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Padula Serums Pty Ltd Licence number: 1123
ACN: 167 348 610
100 Bosworth Road
Bairnsdale Vic 3875
Product types: *
Category 1 – Immunobiologicals and sterile products for injection
Steps of manufacture: Quality assurance (QA) of raw materials, plasma collection, management and immunisation of donor animals, formulation including blending, aseptic filling, analysis and testing (physical, chemical, endotoxin, microbiological, sterility, serological and immunological), sterilisation (filtration), packaging, labelling, storage, release from manufacture only (partial release), release for supply.
Amended licence issued: 27 October 2020
BVAQ Pty Ltd Licence number: 6196
ACN: 004 319 171
Units 3 – 5
352 Macaulay Road
Kensington Vic 3031
Product types: *
Category 6 – Non-sterile dosage forms
Steps of manufacture: Analysis and testing (microbiological).
Amended licence issued: 20 August 2020
BVAQ Pty Ltd Licence number: 6197
ACN: 004 319 171
52 – 58 Mark Street
North Melbourne Vic 3051
Product types: *
Category 6 – All dosage forms
Steps of manufacture: Analysis and testing (chemical and physical).
Amended licence issued: 20 August 2020
Advanced Feeds Pty Ltd Licence number: 2117
ACN: 009 403 623
13 Meliador Way
Midvale WA 6056
Product types: * Category 2 – Powders
Category 4 – Premixes
Steps of manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, storage and release for supply.
Amended licence issued: 31 August 2020
* Category 1: Immunobiologicals and sterile veterinary preparationsCategory 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplementsCategory 3: EctoparasiticidesCategory 4: Premixes and supplementsCategory 5: ExemptCategory 6: Single-step manufacturer
Licensing of Veterinary Chemical Manufacturers
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
Bioproperties Pty Ltd Licence number: 1061
ACN: 007 303 728
11 – 15 Moores Road
Glenorie NSW 2157
Product types: *
Category 1 – Immunobiologicals, sterile diluents
Steps of manufacture: Quality assurance (QA) of raw materials, management of donor animals, virus cultivation, mycoplasma cultivation, bacterial fermentation, oocyst antigen production, oocyst processing, formulation including blending, aseptic filling, filling, packaging, labelling, microbiological reduction treatment (heat, chemical, filtration), sterilisation (heat, chemical, filtration), freeze-drying, analysis and testing (physical, immunobiological, microbiological, oocyst counts), storage and release for supply.
Amended licence issued: 24 November 2020
Western Australian Agriculture Authority
Licence number: 1091
ACN: 86 611 226 341
444 Albany Highway
Albany WA 6330
Product types: *
Category 1 – Immunobiologicals and sterile products for injection
Steps of manufacture: Quality assurance (QA) of raw materials, collection and preparation of nematodes (all stages), antigen extraction, management of donor animals, formulation including blending, wet milling, sterilisation (heat, filtration), microbiological reduction treatment (filtration), aseptic filling, packaging, labelling, analysis and testing (physical, chemical, immunobiological, serological), storage and release for supply.
Amended licence issued: 9 September 2020
Cosmetic Manufacturers (Aust) Pty Ltd
Licence number: 2176
ACN: 010 501 327
14 Kingston Drive
Helensvale Qld 4212
Product types: *
Category 2 – Creams/lotions, sprays, liquids, gels and ointments.
Steps of manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, testing and analysis (physical) and release for supply.
Amended licence issued: 13 November 2020
* Category 1: Immunobiologicals and sterile veterinary preparationsCategory 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplementsCategory 3: EctoparasiticidesCategory 4: Premixes and supplementsCategory 5: ExemptCategory 6: Single-step manufacturer
Licensing of Veterinary Chemical Manufacturers
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
3. LICENCE CANCELLATIONS
The APVMA has cancelled the following licences under subsection 127(1) of the Agvet Code:
Durablend Pty Ltd Licence number: 3036
ACN: 094 764 315
6 Coronation Avenue
Kings Park NSW 2148
Date cancelled: 9 November 2020
Padula Serums Pty Ltd Licence number: 1105
ACN: 167 348 610
26 Howitt Avenue
Bairnsdale Vic 3875
Date cancelled: 16 September 2020
Trend Laboratories Pty Ltd Licence number: 2169
ACN: 001 627 103
1 CoreIla Close
Berkeley Vale NSW 2261
Date cancelled: 17 November 2020
Flores Nominees Pty Ltd Licence number: 2242
ACN: 005 593 091
Unit 2A, 77 – 83 Bayfield Road
East Bayswater Vic 3153
Date cancelled: 5 August 2020
Elanco Australasia Pty Ltd Licence number: 6212
ACN: 076 745 198
112 Wharf Road
West Ryde NSW 2114
Date cancelled: 5 August 2020
* Category 1: Immunobiologicals and sterile veterinary preparationsCategory 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplementsCategory 3: EctoparasiticidesCategory 4: Premixes and supplementsCategory 5: ExemptCategory 6: Single-step manufacturer
Licensing of Veterinary Chemical Manufacturers
Commonwealth of Australia GazetteNo. APVMA 25, Tuesday, 15 December 2020 Agricultural and Veterinary Chemicals Code Act 1994
4. LICENCE SUSPENSIONS
The APVMA has suspended the following licences under subsection 127(1) of the Agvet Code:
QEA Australia Pty Ltd Licence number: 6116
ACN: 114 603 968
Unit 4, 127 Magowar Road
Girraween NSW 2145
Period of suspension: From 18 August 2020 to 17 August 2021
5. REVOCATION OF LICENCE SUSPENSION
Nil
APVMA CONTACT
Manufacturing Quality and Licensing
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Phone: +61 2 6210 4899
Email: [email protected]
* Category 1: Immunobiologicals and sterile veterinary preparationsCategory 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplementsCategory 3: EctoparasiticidesCategory 4: Premixes and supplementsCategory 5: ExemptCategory 6: Single-step manufacturer
Licensing of Veterinary Chemical Manufacturers