apvma gazette no. 20, 6 october 2020 · web viewfor the treatment of otitis externa and skin...
TRANSCRIPT
Gazette Agricultural andVeterinary Chemicals
No. APVMA 20, Tuesday, 6 October 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.
DISTRIBUTION AND SUBSCRIPTION
The APVMA Gazette is published in electronic format only and is available from the APVMA website .
If you would like to subscribe to receive email notification when a new edition is published, please complete the subscription
form .
APVMA CONTACTS
For enquiries regarding the publishing and distribution of the APVMA Gazette: Telephone: +61 2 6770 2300.
For enquiries on the APVMA Gazette content, please refer to the individual APVMA contacts listed under each notice.
Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 6 October 2020 Agricultural and Veterinary Chemicals Code Act 1994
CONTENTS
Erratum Notice.........................................................................................................................................................................
Agricultural Chemical Products and Approved Labels.............................................................................................................
Veterinary Chemical Products and Approved Labels............................................................................................................
Approved Active Constituents................................................................................................................................................
Notice of Cancellation at the Request of the Holder..............................................................................................................
Erratum Notice
The Australian Pesticides and Veterinary Medicines Authority advises that an error was published in the Commonwealth of Australia Gazette for Agricultural and Veterinary Chemicals, No. APVMA 17, Tuesday, 25 August 2020.
In the notice of cancellation at the request of the holder, the incorrect label approval number 85582/113651 was published for the product ‘Conquest Knockout Extreme Herbicide’. The label number which was requested to be cancelled is 85582/113671. The correct notice of cancellation at the request of the holder appears on page 19 of this Gazette.
Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 6 October 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.: 125859
Product name: Fumagard Fumigation Tablets
Active constituent/s: 330 g/kg phosphine (PH3) present as aluminium phosphide
Applicant name: National Fumigants Pty Ltd
Applicant ACN: 090 505 785
Summary of use: For control of insect pests in stored products and for the control of rabbits in burrows
Date of registration: 14 September 2020
Product registration no.:
89708
Label approval no.: 89708/125859
Application no.: 118050
Product name: DEMAND 100CS Insecticide
Active constituent/s: 100 g/L lambda-cyhalothrin
Applicant name: Syngenta Australia Pty Ltd
Applicant ACN: 002 933 717
Summary of use: For control of various insect pests in commercial, domestic, industrial and public situations
Date of registration: 14 September 2020
Product registration no.:
87293
Label approval no.: 87293/118050
Application no.: 126023
Product name: Tricam 500 Fungicide
Active constituent/s: 500 g/L flutriafol
Applicant name: Sipcam Pacific Australia Pty Ltd
Applicant ACN: 073 176 888
Summary of use: For control of certain fungal diseases on wheat, barley and canola when mixed with fertiliser
Date of registration: 14 September 2020
Product registration no.:
89763
Label approval no.: 89763/126023
Application no.: 126078
Product name: WYNCA Chlorothalonil 900 WG Fungicide
Active constituent/s: 900 g/kg chlorothalonil
Applicant name: Zhejiang Xinan Chemical Industrial Group Co Ltd
Applicant ACN: N/A
Summary of use: For the control of fungal diseases on almonds, apricots, bananas, carrots, celery, cherries, faba beans, grapes, onions, peaches, peanuts, peas, plums, potatoes, tomatoes and vegetables
Date of registration: 14 September 2020
Product registration no.:
89783
Label approval no.: 89783/126078
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 6 October 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 123600
Product name: Richgro Effect Non-Residual Weed Killer
Active constituent/s: 1.2 g/L glufosinate-ammonium
Applicant name: A. Richards Pty Ltd
Applicant ACN: 008 734 852
Summary of use: For effective non-residual control of broadleaf and grass weeds in gardens, paths, driveways and along fences
Date of registration: 14 September 2020
Product registration no.:
89103
Label approval no.: 89103/123600
Application no.: 125897
Product name: Relyon Diquat 200 Non-residual Herbicide
Active constituent/s: 200 g/L diquat present as diquat dibromide monohydrate
Applicant name: Nutrien Ag Solutions Limited
Applicant ACN: 008 743 217
Summary of use: For re-harvest crop desiccation and the control of a wide range of broadleaf weeds in certain crops
Date of registration: 16 September 2020
Product registration no.:
89724
Label approval no.: 89724/125897
Application no.: 126065
Product name: Atlas Camphor
Active constituent/s: 1,000 g/kg camphor
Applicant name: Pascoe's Pty Ltd
Applicant ACN: 055 220 463
Summary of use: For repellency of moths and silverfish
Date of registration: 17 September 2020
Product registration no.:
89780
Label approval no.: 89780/126065
Application no.: 126179
Product name: Relyon Azoxy Xtra Fungicide
Active constituent/s: 200 g/L azoxystrobin, 80 g/L cyproconazole
Applicant name: Nutrien Ag Solutions Limited
Applicant ACN: 008 743 217
Summary of use: For the control of certain fungal diseases in barley, wheat and peanuts
Date of registration: 22 September 2020
Product registration no.:
89817
Label approval no.: 89817/126179
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 6 October 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 126113
Product name: Relyon Glyphix 540 Herbicide
Active constituent/s: 540 g/L glyphosate present as the potassium salt
Applicant name: Nutrien Ag Solutions Limited
Applicant ACN: 008 743 217
Summary of use: For non-selective control of many annual and perennial weeds
Date of registration: 22 September 2020
Product registration no.:
89794
Label approval no.: 89794/126113
Application no.: 123553
Product name: Family Protection Aerogard Home Flying Insect Killer
Active constituent/s: 2.5 g/L pyrethrins
Applicant name: RB (Hygiene Home) Australia Pty Ltd
Applicant ACN: 629 549 506
Summary of use: To control common household flying insects
Date of registration: 22 September 2020
Product registration no.:
89082
Label approval no.: 89082/123553
Application no.: 123555
Product name: Family Protection Aerogard Home Multi Insect Killer
Active constituent/s: 3.0 g/L pyrethrins
Applicant name: RB (Hygiene Home) Australia Pty Ltd
Applicant ACN: 629 549 506
Summary of use: To control common household insects
Date of registration: 22 September 2020
Product registration no.:
89083
Label approval no.: 89083/123555
Application no.: 126085
Product name: Wynca Chlorothalonil 720 SC Fungicide
Active constituent/s: 720 g/L chlorothalonil
Applicant name: Zhejiang Xinan Chemical Industrial Group Co Ltd
Applicant ACN: N/A
Summary of use: For the control of fungal diseases on almonds, apricots, bananas, carrots, celery, cherries, faba beans, grapes, onions, peaches, peanuts, peas, plums, potatoes, tomatoes, turf and vegetables
Date of registration: 22 September 2020
Product registration no.:
89784
Label approval no.: 89784/126085
Application no.: 126194
Product name: F.S.A. Clodinafop 240 EC Herbicide
Active constituent/s: 240 g/L clodinafop, 60 g/L cloquintocet-mexyl
Applicant name: Four Seasons Agribusiness Pty Ltd
Applicant ACN: 115 133 189
Summary of use: For the control of wild oats, paradoxa grass (annual phalaris), canary grass and annual ryegrass in wheat
Date of registration: 22 September 2020
Product registration no.:
89827
Label approval no.: 89827/126194
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 6 October 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 123556
Product name: Family Protection Aerogard Home Crawling Insect Killer
Active constituent/s: 4.5 g/L pyrethrins
Applicant name: RB (Hygiene Home) Australia Pty Ltd
Applicant ACN: 629 549 506
Summary of use: To control cockroaches, ants and spiders
Date of registration: 23 September 2020
Product registration no.: 89084
Label approval no.: 89084/123556
Application no.: 127629
Product name: Atlas Camphor Moth & Silverfish Repellent
Active constituent/s: 960 g/kg camphor
Applicant name: Pascoe's Pty Ltd
Applicant ACN: 055 220 463
Summary of use: For repellency of moth and silverfish
Date of registration: 23 September 2020
Product registration no.:
90119
Label approval no.: 90119/127629
Application no.: 127509
Product name: Hovex Camphor Moth & Silverfish Repellent
Active constituent/s: 960 g/kg camphor
Applicant name: Pascoe's Pty Ltd
Applicant ACN: 055 220 463
Summary of use: For repellency of moth and silverfish
Date of registration: 24 September 2020
Product registration no.:
90112
Label approval no.: 90112/127509
Application no.: 126055
Product name: Wynca Trifluralin 480 Herbicide
Active constituent/s: 480 g/L trifluralin
Applicant name: Zhejiang Xinan Chemical Industrial Group Co Ltd
Applicant ACN: N/A
Summary of use: For the control of annual grasses and certain broad-leafed weeds in certain horticultural and agricultural crops
Date of registration: 24 September 2020
Product registration no.:
89774
Label approval no.: 89774/126055
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 6 October 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 126160
Product name: Relyon MCPIK 242 Cereal Herbicide
Active constituent/s: 420 g/L MCPA present as the potassium salt, 26 g/L picloram present as the potassium salt
Applicant name: Nutrien Ag Solutions Limited
Applicant ACN: 008 743 217
Summary of use: For the control of climbing buckwheat, common sowthistle, skeleton weed, capeweed, doublegee and other broadleaf weeds in winter cereals and linseed crops
Date of registration: 24 September 2020
Product registration no.:
89805
Label approval no.: 89805/126160
Application no.: 120681
Product name: Roundup Selective Lawn Weedkiller for Lawns
Active constituent/s: 2.14 g/L MCPA as the dimethylamine salt, 0.5 g/L fluroxypyr as the methyl heptyl ester, 0.18 g/L dicamba as the dimethylamine salt
Applicant name: Evergreen Garden Care Australia Pty Ltd
Applicant ACN: 003 123 162
Summary of use: For the control of common broadleaf lawn weeds in lawns
Date of registration: 25 September 2020
Product registration no.:
88257
Label approval no.: 88257/120681
2. VARIATIONS OF REGISTRATION
Application no.: 127310
Product name: Oxstar Herbicide Coated Fertiliser
Active constituent/s: 10 g/kg oxadiazon
Applicant name: Turf Culture Pty Ltd
Applicant ACN: 117 986 615
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Bison Herbicide Coated Fertiliser’ to ‘Oxstar Herbicide Coated Fertiliser’
Date of variation: 1 September 2020
Product registration no.:
83464
Label approval no.: 83464 /127310
Application no.: 127345
Product name: EuroChem GA4&7 Plant Growth Regulator
Active constituent/s: 20 g/L gibberellin A4 and gibberellin A7
Applicant name: Eurochem Pty Ltd
Applicant ACN: 622 603 507
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘EuroChem novagib Plant Growth Regulator’ to ‘EuroChem GA4&7 Plant Growth Regulator’
Date of variation: 2 September 2020
Product registration no.:
85191
Label approval no.: 85191/127345
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 6 October 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 127475
Product name: Roundup Herbicide
Active constituent/s: 360 g/L glyphosate present as the isopropylamine salt
Applicant name: Monsanto Australia Pty Ltd
Applicant ACN: 006 725 560
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Roundup Herbicide by Monsanto’ to ‘Roundup Herbicide’
Date of variation: 7 September 2020
Product registration no.:
31393
Label approval no.: 31393/127475
Application no.: 127639
Product name: Relyon Clopyralid 750 SG Herbicide
Active constituent/s: 750 g/kg clopyralid present as the potassium salt
Applicant name: Nutrien Ag Solutions Limited
Applicant ACN: 008 743 217
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Insight 750 SG Herbicide’ to ‘Relyon Clopyralid 750 SG Herbicide’
Date of variation: 11 September 2020
Product registration no.:
81837
Label approval no.: 81837/127639
Application no.: 127640
Product name: Relyon Indoxacarb 150EC Insecticide
Active constituent/s: 150 g/L S-indoxacarb
Applicant name: Nutrien Ag Solutions Limited
Applicant ACN: 008 743 217
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Butler 150EC Insecticide’ to ‘Relyon Indoxacarb 150EC Insecticide’
Date of variation: 11 September 2020
Product registration no.:
86540
Label approval no.: 86540/127640
Application no.: 127641
Product name: Relyon 2,4-DB Herbicide
Active constituent/s: 500 g/L 2,4-DB present as the dimethylamine salt
Applicant name: Nutrien Ag Solutions Limited
Applicant ACN: 008 743 217
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Empress 2,4-DB Herbicide’ to ‘Relyon 2,4-DB Herbicide’
Date of variation: 11 September 2020
Product registration no.:
82723
Label approval no.: 82723/127641
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 6 October 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 127642
Product name: Relyon Propyzamide 500 WG Selective Herbicide
Active constituent/s: 500 g/kg propyzamide
Applicant name: Nutrien Ag Solutions Limited
Applicant ACN: 008 743 217
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Prozam 500 WG Herbicide to ‘Relyon Propyzamide 500 WG Selective Herbicide’
Date of variation: 11 September 2020
Product registration no.:
81862
Label approval no.: 81862 /127642
Application no.: 127656
Product name: Relyon Thidiazuron 500 Cotton Defoliant
Active constituent/s: 500 g/L thidiazuron
Applicant name: Nutrien Ag Solutions Limited
Applicant ACN: 008 743 217
Summary of variation:
To vary the distinguishing product name and the name that appears on the label from ‘Descend TDZ Cotton Defoliant’ to ‘Relyon Thidiazuron 500 Cotton Defoliant’
Date of variation: 11 September 2020
Product registration no.:
83190
Label approval no.: 83190/127656
Application no.: 125900
Product name: Ezycrop Tri-Allate 500 EC Herbicide
Active constituent/s: 500 g/L triallate
Applicant name: Ezycrop Pty Ltd
Applicant ACN: 156 476 827
Summary of variation:
To add for use in mustard for the control of wild oats and the control of ryegrass in oil seed poppies
Date of variation: 14 September 2020
Product registration no.:
68078
Label approval no.: 68078/125900
Application no.: 125901
Product name: Titan Propyzamide 500SC Herbicide
Active constituent/s: 500 g/L propyzamide
Applicant name: Titan Ag Pty Ltd
Applicant ACN: 122 081 574
Summary of variation:
To add use instructions for annual ryegrass in pyrethrum crops (Tanacetum cinerariifolium), grass and broadleaf weeds in chicory, endive and radicchio, and mustard uses
Date of variation: 14 September 2020
Product registration no.:
66050
Label approval no.: 66050/125901
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 6 October 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 126173
Product name: Spotlight Plus Herbicide
Active constituent/s: 60 g/L carfentrazone-ethyl
Applicant name: FMC Australasia Pty Ltd
Applicant ACN: 095 326 891
Summary of variation:
To add use patterns for the control of unwanted suckers (cane burning) in Rubus spp and Ribes spp
Date of variation: 14 September 2020
Product registration no.:
61716
Label approval no.: 61716/126173
Application no.: 125647
Product name: Family Protection Aerogard Body Tropical Strength 8 Hours Protection Insect Repellent Spray
Active constituent/s: 170.9 g/L diethyltoluamide, 35.8 g/L N-octyl bicycloheptene dicarboximide
Applicant name: RB (Hygiene Home) Australia Pty Ltd
Applicant ACN: 629 549 506
Summary of variation:
To change the product name and extend the label claims to 8 hours protection against mosquitoes, sandflies, and leeches
Date of variation: 22 September 2020
Product registration no.:
61511
Label approval no.: 61511/125647
Application no.: 126170
Product name: ProGibb LV Plus Plant Growth Regulator Liquid
Active constituent/s: 100 g/L gibberellic acid
Applicant name: Valent Biosciences (A Div Of Sumitomo Chemical Australia)
Applicant ACN: 081 096 255
Summary of variation:
Variation of registration and label approval to extend the use to cherries
Date of variation: 22 September 2020
Product registration no.:
83632
Label approval no.: 83632/126170
Application no.: 124420
Product name: Silverado Herbicide
Active constituent/s: 375 g/kg MCPA present as the sodium salt, 60 g/kg carfentrazone-ethyl
Applicant name: Turf Culture Pty Ltd
Applicant ACN: 117 986 615
Summary of variation:
To vary the instructions, add new turf species and make some minor changes to the relevant label particular text
Date of variation: 24 September 2020
Product registration no.:
63103
Label approval no.: 63103/124420
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 6 October 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 125775
Product name: Rid Australia Medicated Rid Insect Repellent Tropical Strength + Antiseptic Spray 6 Hours Mosquito Protection Neutral Scent
Active constituent/s: 191 g/kg N,N-diethly-m-toluamide, 40 g/kg N-octyl bicycloheptene dicarboximide, 1 g/kg triclosan
Applicant name: Cavalieri Investing Pty Ltd
Applicant ACN: 162 722 625
Summary of variation:
To update the product name to ‘Rid Australia Medicated Rid Insect Repellent Tropical Strength + Antiseptic Spray 6 Hours Mosquito Protection Neutral Scent’
Date of variation: 25 September 2020
Product registration no.:
53407
Label approval no.: 53407/125775
Application no.: 126124
Product name: Maxunitech Carfentrazone-ethyl 400 g/L EC
Active constituent/s: 400 g/L carfentrazone-ethyl
Applicant name: Oriental (Luzhou) Agrochemicals Co Ltd
Applicant ACN: N/A
Summary of variation:
To add control of unwanted suckers (cane burning) in Rubus spp and Ribes spp
Date of variation: 25 September 2020
Product registration no.:
87532
Label approval no.: 87532/126124
3. LABEL APPROVAL
Application no.: 126513
Product name: Farmalinx Winx Herbicide
Active constituent/s: 100 g/kg iodosulfuron-methyl-sodium
Applicant name: Farmalinx Pty Ltd
Applicant ACN: 134 353 245
Summary of variation:
To approve a new label for the product 'Farmalinx Winx Herbicide' with the label name 'ProForce Duke 100 WG Herbicide'
Date of variation: 17 September 2020
Product registration no.:
88829
Label approval no.: 88829/126513
4. VARIATION OF LABEL APPROVAL
Application no.: 126038
Product name: Combat Moth-Rid Pantry Moth Trap
Active constituent/s: 4.9 g/kg (Z,E)-9,12-tetradecadien-1-yl acetate
Applicant name: Henkel Australia Pty Ltd
Applicant ACN: 001 302 996
Summary of variation:
To vary the statement of claims
Date of variation: 25 September 2020
Product registration no.:
89180
Label approval no.: 89180/126038
Agricultural Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 6 October 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.: 124989
Product name: Abate Ear Suspension
Active constituent/s: 23.0 mg/mL miconazole nitrate, 5.0 mg/mL prednisolone acetate, 0.529 mg/mL polymixin B sulfate
Applicant name: Probus Pharmaceuticals Pty Ltd
Applicant ACN: 638 193 674
Summary of use: For the treatment of otitis externa and skin infections caused by fungi, yeasts, gram-negative and gram-positive bacteria and Otodectes cynotis in dogs and cats
Date of registration: 15 September 2020
Product registration no.:
89478
Label approval no.: 89478/124989
Application no.: 126138
Product name: Feloxicam Oral Suspension For Cats
Active constituent/s: 0.5 mg/mL meloxicam
Applicant name: Ferrari Animal Health Pty Ltd
Applicant ACN: 162 206 671
Summary of use: For alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders in cats
Date of registration: 16 September 2020
Product registration no.:
89799
Label approval no.: 89799/126138
Application no.: 125946
Product name: [Wagg & Purr] Dogs & Cats Antimicrobial Ear & Skin Suspension
Active constituent/s: 23 mg/mL miconazole nitrate, 5 mg/mL prednisolone acetate, 0.696 mg/mL polymyxin Bsulphate
Applicant name: Avet Health Pty Ltd
Applicant ACN: 616 838 101
Summary of use: For the treatment of otitis externa and skin infections in dogs, cats and horses
Date of registration: 22 September 2020
Product registration no.:
89742
Label approval no.: 89742/125946
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 6 October 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 123589
Product name: Monemix Technical Premix
Active constituent/s: Not less than 800 mg/g monensin as monensin sodium
Applicant name: Abbey Laboratories Pty Ltd
Applicant ACN: 156 000 430
Summary of use: A premix product for use as an aid in prevention of coccidiosis for use in cattle, sheep, goats and chickens, an aid in control of bloat in feedlot and dairy cattle, improved feed efficiency in feedlot cattle, improved feed efficiency and weight gain in heifers and sheep, increased milk production and aid in reducing severity of non-clinical ketosis in dairy cows and improved reproductive performance in heifers
Date of registration: 23 September 2020
Product registration no.:
89100
Label approval no.: 89100/123589
Application no.: 121817
Product name: LYDAXX™ Injectable Solution
Active constituent/s: 100 mg/mL tulathromycin
Applicant name: Vetoquinol Australia Pty Ltd
Applicant ACN: 006 949 480
Summary of use: For the treatment of respiratory infections in swine and cattle
Date of registration: 23 September 2020
Product registration no.:
88610
Label approval no.: 88610/121817
Application no.: 115514
Product name: NutriMONENSIN 400P Feed Additive Premix
Active constituent/s: 400 g/kg monensin as monensin sodium
Applicant name: Nutriment Health Pty Ltd
Applicant ACN: 138 061 266
Summary of use: For use in cattle and goats and layer replacements and broilers to control coccidiosis and in beef and dairy cattle to reduce disease and improve production
Date of registration: 24 September 2020
Product registration no.:
86338
Label approval no.: 86338/115514
Application no.: 126237
Product name: [Wagg & Purr] Dogs & Cats Cephalexin 500mg Tablets
Active constituent/s: 500 mg/tb cephalexin as monohydrate
Applicant name: Avet Health Pty Ltd
Applicant ACN: 616 838 101
Summary of use: For the treatment of susceptible bacterial infections in dogs and cats
Date of registration: 24 September 2020
Product registration no.:
89852
Label approval no.: 89852/126237
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 6 October 2020 Agricultural and Veterinary Chemicals Code Act 1994
2. VARIATIONS OF REGISTRATION
Application no.: 127356
Product name: Domised Injection
Active constituent/s: 1 mg/mL medetomidine hydrochloride
Applicant name: Abbey Laboratories Pty Ltd
Applicant ACN: 156 000 430
Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Anihealth Cip-Medeto Injection’ to ‘Domised Injection’
Date of variation: 3 September 2020
Product registration no.:
66333
Label approval no.: 66333/127356
Application no.: 126075
Product name: Cormedin 2.5 mg Tablets For Dogs
Active constituent/s: 2.5 mg/tablet pimobendan
Applicant name: Jurox Pty Ltd
Applicant ACN: 000 932 230
Summary of variation: To add a claim for treatment of dogs with evidence of increased heart size secondary to asymptomatic (preclinical) myxomatous mitral valve disease
Date of variation: 17 September 2020
Product registration no.:
83489
Label approval no.: 83489/126075
Application no.: 126074
Product name: Cormedin 1.25 mg Tablets For Dogs
Active constituent/s: 1.25 mg/tablet pimobendan
Applicant name: Jurox Pty Ltd
Applicant ACN: 000 932 230
Summary of variation: To add a claim for treatment of dogs with evidence of increased heart size secondary to asymptomatic (preclinical) myxomatous mitral valve disease
Date of variation: 17 September 2020
Product registration no.:
83487
Label approval no.: 83487/126074
Application no.: 126076
Product name: Cormedin 5 mg Tablets for Dogs
Active constituent/s: 5 mg/tablet pimobendan
Applicant name: Jurox Pty Ltd
Applicant ACN: 000 932 230
Summary of variation: To add a claim for treatment of dogs with evidence of increased heart size secondary to asymptomatic (preclinical) myxomatous mitral valve disease
Date of variation: 17 September 2020
Product registration no.:
83486
Label approval no.: 83486/126076
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 6 October 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 121583
Product name: Dermcare Immunotherapy
Active constituent/s: 1000–2000 PNU allergenic mixture (vial 1), 10,000–20,000 PNU allergenic mixture (vial 2)
Applicant name: Dermcare-Vet Pty Ltd
Applicant ACN: 010 280 010
Summary of variation: To vary the particulars of the registered product and label approval by updating the constituents of the product and label
Date of variation: 17 September 2020
Product registration no.:
45991
Label approval no.: 45991/121583
Application no.: 123721
Product name: Draxxin Injectable Solution
Active constituent/s: 100 mg/mL tulathromycin
Applicant name: Zoetis Australia Pty Ltd
Applicant ACN: 156 476 425
Summary of variation: To add an additional pack size
Date of variation: 22 September 2020
Product registration no.:
60018
Label approval no.: 60018/123721
Application no.: 126102
Product name: Ilium Meloxicam 20 Anti-inflammatory Injection for Cattle, Pigs and Horses
Active constituent/s: 20 mg/mL meloxicam
Applicant name: Troy Laboratories Pty Ltd
Applicant ACN: 000 283 769
Summary of variation: To extend product use in sheep
Date of variation: 23 September 2020
Product registration no.:
62535
Label approval no.: 62535/126102
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 6 October 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 126196
Product name: Ilium Frusemide Injection
Active constituent/s: 50 mg/mL frusemide
Applicant name: Troy Laboratories Pty Ltd
Applicant ACN: 000 283 769
Summary of variation: To update storage instructions
Date of variation: 25 September 2020
Product registration no.:
50268
Label approval no.: 50268/126196
3. VARIATION OF LABEL APPROVAL
Application no.: 126155
Product name: Ilium Meloxicam 12 Anti-inflammatory Oral Suspension For Foals
Active constituent/s: 12 mg/mL meloxicam
Applicant name: Troy Laboratories Pty Ltd
Applicant ACN: 000 283 769
Summary of variation: To update label as per the Veterinary Labelling Code
Date of variation: 17 September 2020
Product registration no.:
65030
Label approval no.: 65030/126155
Application no.: 126377
Product name: lium Meloxicam 30 Anti-inflammatory Oral Suspension For Horses
Active constituent/s: 30 mg/mL meloxicam
Applicant name: Troy Laboratories Pty Ltd
Applicant ACN: 000 283 769
Summary of variation: To update label as per the Veterinary Labelling Code
Date of variation: 17 September 2020
Product registration no.:
64495
Label approval no.: 64495/126377
Application no.: 126372
Product name: Ilium Atipamezole Injection
Active constituent/s: 5 mg/mL atipamezole hydrochloride
Applicant name: Troy Laboratories Pty Ltd
Applicant ACN: 000 283 769
Summary of variation: To update label as per the Veterinary Labelling Code
Date of variation: 17 September 2020
Product registration no.:
66256
Label approval no.: 66256/126372
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 6 October 2020 Agricultural and Veterinary Chemicals Code Act 1994
Application no.: 126374
Product name: Ilium Oxytet-200 L.A. Long-Acting Broad-Spectrum Antibiotic Injection
Active constituent/s: 200 mg/mL oxytetracycline as the base
Applicant name: Troy Laboratories Pty Ltd
Applicant ACN: 000 283 769
Summary of variation: To update label as per the Veterinary Labelling Code
Date of variation: 17 September 2020
Product registration no.:
40057
Label approval no.: 40057/126374
Application no.: 126382
Product name: Ilium Propercillin Antibiotic Injection
Active constituent/s: 300 mg/mL procaine penicillin
Applicant name: Troy Laboratories Pty Ltd
Applicant ACN: 000 283 769
Summary of variation: To update label as per the Veterinary Labelling Code
Date of variation: 17 September 2020
Product registration no.:
60521
Label approval no.: 60521/1263824
Application no.: 125979
Product name: Tribactral S Antibacterial Solution For Injection
Active constituent/s: 200 mg/mL sulfadoxine, 40 mg/mL trimethoprim
Applicant name: Intervet Australia Pty Ltd
Applicant ACN: 008 467 034
Summary of variation: To update the label as per the Veterinary Labelling Code
Date of variation: 23 September 2020
Product registration no.:
53733
Label approval no.: 53733/125979
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 6 October 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.: 123963
Active constituent/s:
Esbiothrin
Applicant name: Endura S.P.A.
Applicant ACN: N/A
Summary of use: For use in agricultural chemical products
Date of approval: 16 September 2020
Approval no.: 89200
Application no.: 123979
Active constituent/s:
Spinosad
Applicant name: Qilu Pharmaceutical (Inner Mongolia) Co Ltd
Applicant ACN: N/A
Summary of use: For use in agricultural and veterinary chemical products
Date of approval: 21 September 2020
Approval no.: 89208
Application no.: 124230
Active constituent/s:
Monensin sodium
Applicant name: Abbey Laboratories Pty Ltd
Applicant ACN: 156 000 430
Summary of use: For use in veterinary chemical products
Date of approval: 23 September 2020
Approval no.: 89273
Application no.: 124210
Active constituent/s:
Tebuconazole
Applicant name: Bayer Cropscience Pty Ltd
Applicant ACN: 000 226 022
Summary of use: For use in agricultural chemical products
Date of approval: 25 September 2020
Approval no.: 89272
Application no.: 124162
Active constituent/s:
Deltamethrin
Applicant name: Tagros Chemicals India Private Limited
Applicant ACN: N/A
Summary of use: For use in for use in agricultural and veterinary chemical products
Date of approval: 25 September 2020
Approval no.: 89247
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 6 October 2020 Agricultural and Veterinary Chemicals Code Act 1994
2. VARIATIONS OF ACTIVE CONSTITUENT
Application no.: 124500
Active constituent: Fluocinolone acetonide
Applicant name: Troy Laboratories Pty Ltd
Applicant ACN: 000 283 769
Summary of variation:
Variation of relevant particulars or conditions of an approved active constituent
Date of variation: 18 September 2020
Approval no.: 55337
Application no.: 125793
Active constituent: Follicle stimulating hormone
Applicant name: Vetoquinol Australia Pty Ltd
Applicant ACN: 006 949 480
Summary of variation:
Variation of relevant particulars or conditions of an approved active constituent
Date of variation: 21 September 2020
Approval no.: 83280
Veterinary Chemical Products and Approved Labels
Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 6 October 2020 Agricultural and Veterinary Chemicals Code Act 1994
Notice of Cancellation at the Request of the Holder
At the request of the holder, in accordance with section 42(1) of the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code), the Australian Pesticides and Veterinary Medicines Authority (APVMA) has cancelled the approvals and/or registrations set out in the table below.
Approval or registration number
Name Type of approval or registration
Holder Date of cancellation
33274/1097
33274/1209
33274/0100
33274/0304
Mesurol Snail And Slug Bait
Label approvalsBayer Cropscience Pty Ltd
23 September 2020
51851/100882
51851/55632
51851/0599
Baysol Snail & Slug Bait
Label approvalsBayer Cropscience Pty Ltd
23 September 2020
41140Amalgamated Pest Control Silico Dust Insecticide
Product registrationAmalgamated Pest Control Pty Ltd
15 September 2020
41140/0900Amalgamated Pest Control Silico Dust Insecticide
Label approvalAmalgamated Pest Control Pty Ltd
15 September 2020
64992/117639
Family Protection Aerogard Mozzie Zapper Mosquito & Fly Control
Label approvalsRb (Hygiene Home) Australia Pty Ltd
1 September 2020
64992/5780364992/5532164992/49797
Mortein Mozzie And Fly Repellent Liquid
Label approvalsRb (Hygiene Home) Australia Pty Ltd
1 September 2020
68503/117277
Virkon Aquatic Broad Spectrum Virucidal Bactericidal Fungicidal Disinfectant
Label approvalAlltech Lienert Australia Pty. Ltd.
24 August 2020
85582/113671Conquest Knockout Extreme Herbicide
Label approvalConquest Crop Protection Pty Ltd
24 July 2020
In accordance with section 45A(1)(b) of the Agvet Code, the APVMA publishes this notice of the cancellation, including the following instructions which set out how a person can deal with the cancelled active constituent, cancelled product or product bearing a cancelled label referred to in the above table.
Notice of Cancellation at the Request of the Holder
Commonwealth of Australia GazetteNo. APVMA 20, Tuesday, 6 October 2020 Agricultural and Veterinary Chemicals Code Act 1994
INSTRUCTIONS FOR PERSONS WHO POSSESS, HAVE CUSTODY OF OR USE THE CANCELLED ACTIVE CONSTITUENT, CANCELLED PRODUCT, OR THE PRODUCT BEARING A CANCELLED LABEL UNDER SECTION 45B(3) OF THE AGVET CODE
A person who possesses, has custody of or uses the cancelled active constituent, cancelled product or product bearing a cancelled label referred to in the above table in accordance with the instructions contained in this notice, is taken to have been issued with a permit under section 45B(3) of the Agvet Code to possess, have custody of or use the cancelled active constituent, cancelled product or product bearing a cancelled label, in accordance with those instructions.
POSSESSION OR CUSTODY
A person may possess the cancelled active constituent, cancelled product or product bearing a cancelled label referred to in the above table in accordance with its label instructions for 12 months from the date of cancellation.
USE, SUPPLY OR OTHERWISE DEAL WITH
A person may use the cancelled active constituent, cancelled product or products bearing a cancelled label referred to in the above table according to its label instructions, including any conditions relating to shelf life or expiry date, for 12 months after the date of cancellation.
A person may supply or cause to be supplied at wholesale or retail level the cancelled active constituent, cancelled product, or product bearing a cancelled label referred to in the above table, for 12 months after the date of cancellation.
CONTRAVENTIONS
After the day that is 12 months from the date of cancellation it will be an offence against the Agvet Code to have possession or custody of the cancelled active constituents, cancelled products or products bearing a cancelled label with the intention to supply, or to supply the cancelled active constituent, cancelled product, or product bearing a cancelled label.
It is an offence to possess, have custody of, use, or otherwise deal with the cancelled active constituents, cancelled products or products bearing the cancelled label listed in the table above in a manner that contravenes the above instructions.
APVMA CONTACT
For any enquiries or further information about this matter, please contact:
Chemical ReviewAustralian Pesticides and Veterinary Medicines AuthorityGPO Box 3262Sydney NSW 2001
Phone: +61 2 6770 2400
Email: [email protected]
Notice of Cancellation at the Request of the Holder