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

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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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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..................................................................................................................


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


Product name: Oracle EC Insecticide

Active constituent/s: 17 g/L emamectin present as emamectin benzoate

Applicant name: Adama Australia Pty Ltd


Summary of use: For control or suppression of various insect pests in brassica vegetables, capsicum, grapes, lettuce, sweet corn and tomatoes



90104



Product name: Warlock EC Insecticide

Active constituent/s: 17 g/L emamectin present as emamectin benzoate



Summary of use: For control or suppression of various insect pests in canola, cotton and pulses



90105



Product name: Surefire Spirotetramat 240 SC Insecticide

Active constituent/s: 240 g/L spirotetramat

Applicant name: PCT Holdings Pty Ltd


Summary of use: For control of various insect pests in cotton and certain fruit and vegetable crops



89337





Product name: Genfarm Gibberellic Acid 100 Growth Regulator

Active constituent/s: 100 g/L gibberellic acid

Applicant name: Nutrien Ag Solutions Limited


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



89567



Product name: Baysol® Snail And Slug Bait Iron

Active constituent/s: 60 g/kg iron EDTA complex

Applicant name: Wattleglen Projects Pty Ltd


Summary of use: For use in control of snails and slugs in the home garden



90350



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


Summary of use: For selective control of various weeds in crops, pastures and non-agricultural areas



90035



Product name: Barmac MCPA 750 Selective Herbicide

Active constituent/s: 750 g/L MCPA present as the dimethylamine salt

Applicant name: Amgrow Pty Ltd


Summary of use: For the selective control of broadleaf weeds in cereals, linseed, oilseed poppies, pastures, rice, sugar cane and turf



90114





Product name: Accensi Carbendazim 500 SC Fungicide

Active constituent/s: 500 g/L carbendazim



Summary of use: For the control of fungal diseases in chickpeas, faba beans, lentils, vetch and macadamia nuts



90113



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



89096



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


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


89005



Product name: Weed Force Ninja Herbicide

Active constituent/s: 200 g/L triclopyr, 100 g/L picloram

Applicant name: Weed Force Pty Ltd


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



90140





Product name: Conquest Wingman 500 WG Herbicide

Active constituent/s: 500 g/kg flumioxazin

Applicant name: Conquest Crop Protection Pty Ltd


Summary of use: For pre-plant knockdown of various weeds



88854



Product name: Choice Katana 600 Herbicide

Active constituent/s: 600 g/L dichlorprop present as the potassium salt

Applicant name: Grow Choice Pty Ltd


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



89401



Product name: Conquest Preceed 850 WG Herbicide

Active constituent/s: 850 g/kg pyroxasulfone

Applicant name: Conquest Crop Protection Pty Ltd


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



89148



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


Summary of use: For control of bacteria and biofilm, and for proactive management of protozoa, including Cryptosporidium spp., in swimming pools



89891





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


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



90144



Product name: CropSure Parashot 250 Herbicide

Active constituent/s: 250 g/L paraquat present as paraquat dichloride

Applicant name: CropSure Pty Ltd


Summary of use: For the control of a wide range of grasses and broadleaf weeds



90155



Product name: Cropsure Slammer 400 EC Herbicide

Active constituent/s: 400 g/L carfentrazone-ethyl

Applicant name: Cropsure Pty Ltd


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


Product registration no.: 90129


2. VARIATIONS OF REGISTRATION


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


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


88704





Product name: EDN Fumigant

Active constituent/s: 1,000 g/kg ethanedinitrile

Applicant name: Draslovka Services Pty Ltd



To vary the distinguishing product name and the name that appears on the label from ‘EDN Fumigas’ to ‘EDN Fumigant’



60096



Product name: Sequence 360 Herbicide

Active constituent/s: 360 g/L clethodim

Applicant name: Nufarm Australia Limited



To vary the distinguishing product name and the name that appears on the label from ‘Havoc Plus 360 Herbicide’ to ‘Sequence 360 Herbicide’



90052



Product name: Nufarm Triflurx Selective Herbicide

Active constituent/s: 480 g/L trifluralin




To add a use in wheat and to add uses under the APVMA Permit to Label Project



56421



Product name: Suscon Maxi Intel Soil Insecticide

Active constituent/s: 50 g/kg imidacloprid




To accommodate modern dual row planting systems and to simplify the directions for use table



70098





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


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



59159



Product name: Storm 960 Herbicide

Active constituent/s: 960 g/L S-metolachlor

Applicant name: Sunrise Crop Science Co Ltd

Applicant ACN: N/A


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



86836



Product name: Octave WP Fungicide

Active constituent/s: 462 g/kg prochloraz as the manganese chloride complex

Applicant name: FMC Australasia Pty Ltd



To add use in additional jurisdictions for non-fruiting strawberry runners



30485



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



To include control of house flies and to change the product name



88298





Product name: Tebby 430 Fungicide


Applicant name: Crop Culture Pty Ltd



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



82030



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



To include new fallow, pre-and post-harvest use and general weed control use situations



88261



Product name: Imtrade Trifluralin 480 EC Herbicide


Applicant name: Imtrade Australia Pty Ltd



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



63455



Product name: Fosetyl 800 Fungicide

Active constituent/s: 800 g/kg fosetyl-aluminium

Applicant name: Turf Culture Pty Ltd



To extend the use to include apples, peaches, avocados, pineapples and include a 100 sq metre rate for turf



69562





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


To add use in mustard



88389



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


To update product label in line with current Ag Labelling Code and FAISD Handbook guidelines



65926



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



To change the product name



69786



Product name: Nufarm Spin Flo Systemic Fungicide

Active constituent/s: 500 g/L carbendazim




To add use in field grown garlic to control botrytis



59815





Product name: Expedite Full Insecticide

Active constituent/s: 500 g/kg sulfoxaflor

Applicant name: Dow Agrosciences Australia Limited



To add use situations in tree nuts; pack sizes; and to include required restraints



65464



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 ACN: N/A


To amend the product label in line with the 2,4-D reconsideration final regulatory decision

Date of variation: 1 December 2020


65224



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 ACN: N/A


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



56339



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




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



68535





Product name: Imtrade Pirimicarb 500 WG Aphicide

Active constituent/s: 500 g/kg pirimicarb (an anticholinesterase compound)

Applicant name: Imtrade Australia Pty Ltd



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



60138



Product name: Accensi Tri-Max 480 EC Herbicide





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



81536



Product name: Orius 430 SC Fungicide





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



58773



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



To include use in Tasmania for the control of powdery mildew in grapes, pumpkins and marrows



67918





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


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



87542



Product name: Accensi Metolachlor 720 Herbicide

Active constituent/s: 720 g/L metolachlor




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



63171



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



To update the safety directions and first aid instructions



86305


3. LABEL APPROVAL


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



To approve a new label for the product 'Lo-Chlor Spa Sanitiser' with the label name 'Iluka Spa Purifier'



85547




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


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


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



88862



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)



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



88864



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


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



88237





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


Summary of use: For use as an aid in reduction of disease caused by Barber's Pole worm in lambs, yearlings and ewes



90013



Product name: [Wagg & Purr] Enrofloxacin Injection

Active constituent/s: 50 mg/mL enrofloxacin

Applicant name: Avet Health Pty Ltd


Summary of use: For the treatment of diseases caused by susceptible bacterial pathogens



90159



Product name: CarproJect 50mg/mL Injection

Active constituent/s: 50 mg/mL carprofen

Applicant name: Probus Pharmaceuticals Pty Ltd


Summary of use: For use as a non-steroidal, anti-inflammatory and analgesic in dogs, cats and horses



89833



Product name: Jurox TMPS Antibacterial Suspension For Injection

Active constituent/s: 400 mg/mL sulfadiazine, 80 mg/mL trimethoprim

Applicant name: Jurox Pty Ltd


Summary of use: For the treatment of infections caused by organisms sensitive to trimethoprim and sulfadiazine in cattle, sheep, pigs and horses



89892





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


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



90115



Product name: Jurox Imida-Moxi Spot-On For Dogs 4 – 10 kg

Active constituent/s: 100 g/L imidacloprid, 25 g/L moxidectin



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



89911



Product name: Jurox TMPS Antibacterial Solution For Injection

Active constituent/s: 200 mg/mL sulfadoxine, 40 mg/mL trimethoprim



Summary of use: For the treatment of infections caused by organisms sensitive to trimethoprim and sulfadoxine in cattle, sheep, pigs, horses, cats and dogs



89895





Product name: Randlab Tulathromycin Injection

Active constituent/s: 100 mg/mL tulathromycin

Applicant name: Randlab Australia Pty Ltd


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



90158


2. VARIATIONS OF REGISTRATION


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



To add an additional pack size, extension of use to pigs and poultry and to change the product name



36152



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



To update the in-use shelf life statement for the product



35995



Product name: Zolexx Paste For Horses

Active constituent/s: 370 mg/g omeprazole

Applicant name: Abbey Laboratories Pty Ltd



To update pack sizes by including additional net contents 28 x 6.15 g, 33 g and 6 x 33 g



63080





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)




To update general directions statement of the label



38796



Product name: Methone Injection

Active constituent/s: 10 mg/mL methadone hydrochloride

Applicant name: Ceva Animal Health Pty Ltd



To amend the in-use shelf life statement



41455


3. VARIATION OF LABEL APPROVAL


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



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


Product registration no.: 62393



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




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



62392





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







62391



Product name: Sentinel Spectrum Tasty Chews For Large Dogs

Active constituent/s: 460 mg lufenuron, 228 mg praziquantel, 23 mg milbemycin oxime per chew







62390




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


Active constituent/s:

Dicyclanil



Summary of use: For use in veterinary chemical products

Date of approval: 24 November 2020

Approval no.: 89521



Aclonifen

Applicant name: Bayer Cropscience Pty Ltd


Summary of use: For use in agricultural chemical products


Approval no.: 88338



H. contortus integral membrane glycoproteins

Applicant name: Wormvax Australia Pty Ltd




Approval no.: 90117



Albendazole oxide





Approval no.: 89023



Sulfoxaflor

Applicant name: Dow Agrosciences Australia Limited



Date of approval: 2 December 2020

Approval no.: 89571





S-lactic acid





Approval no.: 89351



Lufenuron

Applicant name: Ferrari Animal Health Pty Ltd




Approval no.: 89952



Milbemycin oxime

Applicant name: Ferrari Animal Health Pty Ltd




Approval no.: 89960



Oxytetracycline dihydrate





Approval no.: 89962



Prothioconazole

Applicant name: Trustchem Co Ltd

Applicant ACN: N/A



Approval no.: 89098



Meloxicam

Applicant name: Chanelle Pharmaceuticals Manufacturing Ltd

Applicant ACN: N/A

Summary of use: For use in veterinary chemical product s


Approval no.: 89764



2. VARIATIONS OF ACTIVE CONSTITUENT



Triclabendazole

Applicant name: Boehringer Ingelheim Animal Health Australia Pty Ltd



Variation of relevant particulars or conditions of an approved active constituent


Approval no.: 81937



Moxidectin

Applicant name: Boehringer Ingelheim Animal Health Australia Pty Ltd





Approval no.: 82193



Silver sulfadiazine






Approval no.: 56281



Flumethrin






Approval no.: 62446



Moxidectin






Approval no.: 81957



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


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


The State of NSW Department Of Industry Trading Under The Business Name Of Department Of Primary Industries (Elizabeth Macarthur Agricultural Institute)


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.


Ferngrove Pharmaceutical Australia Pty Ltd


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




Eurofins Chemical Analysis Pty Ltd


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).


Delta Laboratories Pty Ltd Licence number: 6234

ACN: 050 324 742

9 Chivers Road

Somersby NSW 2250


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


Steps of manufacture: Release for supply


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





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).


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.





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.


Western Australian Agriculture Authority


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


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.





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


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




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]



mailto:[email protected]

APVMA Gazette No. 25, 15 December 2020 · Web view100 g/kg chlorine dioxide (ClO 2) present as 200...

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Transcript of APVMA Gazette No. 25, 15 December 2020 · Web view100 g/kg chlorine dioxide (ClO 2) present as 200...