NRA Gazette No. 5 7 May 2002 page 12

VETERINARY CHEMICAL PRODUCTS

1. VETERINARY PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS:

Product Name: Gastroshield Paste for Horses
Active Constituent/s: 370 g/kg omeprazole
Applicant Name: Merial Australia Pty Ltd
Applicant ACN: 071 187 285
Summary of Use: For the treatment and prevention of recurrence of gastric ulcers in horses and foals under the direction of a veterinary surgeon.
Date of Registration: 2 April 2002
Label Approval No: 52962/0402

Product Name: Vetmedin 2.5 MG Capsules for Dogs
Active Constituent/s: Each capsule contains 2.5 mg pimobendan
Applicant Name: Boehringer Ingelheim Pty Ltd
Applicant ACN: 000 452 308
Summary of Use: For the treatment of canine congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricusprid regurgitation).
Date of Registration: 3 April 2002
Label Approval No: 53561/0402

Product Name: Vetmedin 5 MG Capsules for Dogs
Active Constituent/s: Each capsule contains 5 mg pimobendan
Applicant Name: Boehringer Ingelheim Pty Ltd
Applicant ACN: 000 452 308
Summary of Use: For the treatment of canine congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricusprid regurgitation).
Date of Registration: 3 April 2002
Label Approval No: 53562/0402

Product Name: Protech Duramune C2I Canine Coronavirus & Leptospira Icterohaemorrhagiae Killed Vaccine
Active Constituent/s: Canine coronavirus and Leptospira icterohaemorrhagiae antigen
Applicant Name: Fort Dodge Australia Pty Limited
Applicant ACN: 000 074 902
Summary of Use: For the immunisation of healthy dogs, 6 weeks of age or older to protect against disease caused by Leptospira icterohaemorrhagiae and aid in protection against disease caused by canine coronavirus. These vaccines can be used for the prevention of clinical disease, however they may fail to prevent infection or organism shedding.
Date of Registration: 8 April 2002
Label Approval No: 51488/0302

Product Name: Gudair Vaccine
Active Constituent/s: 2.5 mg/mL mycobacterium paratuberculosis
Applicant Name: CSL Limited
Applicant ACN: 051 588 348
Summary of Use: Active immunisation for the control of Johne's disease and reduction in faecal Mycobacterium paratuberculosis shedding in sheep. Active immunisation as an aid in the control of Johne's disease in goats.
Date of Registration: 16 April 2002
Label Approval No: 53839/0402

2. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS:

Product Name: Exact 100 Oxytetracycline Hydrochloride 100 MG/ML Injection
Active Constituent/s: 100 mg/mL oxytetracycline hydrochloride
Applicant Name: Eurovet Animal Health BV
Summary of Use: For the treatment of infections caused by bacteria sensitive to oxytetracycline in cattle, sheep, pigs, horses, dogs and cats.
Date of Registration: 19 March 2002
Label Approval No: 53204/0302

Product Name: Virbac Cyclio Palatable Flea Control Tablets for Dogs and Puppies
Active Constituent/s: Each tablet contains 100 mg pyriproxyfen
Applicant Name: Virbac (Australia) Pty Ltd
Applicant ACN: 003 268 871
Summary of Use: Analogue of flea juvenile hormone for the control of fleas(Ctenocephalides spp.) in dogs by arresting flea larval development, sterilisation of eggs or ovicidal activity in adult fleas.
Date of Registration: 22 March 2002
Label Approval No: 54507/0302

Product Name: Bob Martin Vetcare Double Action Dog Spot for Small to Medium Dogs
Active Constituent/s: 3 g/L pyriproxyfen, 400 g/L permethrin (40:60::cis:trans)
Applicant Name: Bob Martin (Australia) Pty Ltd
Applicant ACN: 062 627 883
Summary of Use: For the treatment and control of fleas (Ctenocephalides felis) and ticks (Rhipicephalus sanguineus) in dogs.
Date of Registration: 26 March 2002
Label Approval No: 55580/0302

Product Name: Bob Martin Vetcare Double Action Dog Spot for Large Dogs
Active Constituent/s: 3 g/L pyriproxyfen, 400 g/L permethrin (40:60::cis:trans)
Applicant Name: Bob Martin (Australia) Pty Ltd
Applicant ACN: 062 627 883
Summary of Use: For the treatment and control of fleas (Ctenocephalides felis) and ticks (Rhipicephalus sanguineus) in dogs.
Date of Registration: 26 March 2002
Label Approval No: 55583/0302

Product Name: Friskies Tasty 6 Weekly Heartworm and Allwormer for Small Dogs and Puppies
Active Constituent/s: Each tablet contains 0.05 mg abamectin, 25 mg praziquantel, 112.5 mg oxibendazole
Applicant Name: Virbac (Australia) Pty Ltd
Applicant ACN: 003 268 871
Summary of Use: For the prevention of heartworm disease and the treatment of roundworm, hookworm, whipworm and tapeworm (including hydatid tapeworm) in dogs up to 5 kg.
Date of Registration: 26 March 2002
Label Approval No: 55254/0302

Product Name: Friskies Tasty 6 Weekly Heartworm and Allwormer for Dogs
Active Constituent/s: Each tablet contains 0.1 mg abamectin, 50 mg praziquantel, 225 mg oxibendazole
Applicant Name: Virbac (Australia) Pty Ltd
Applicant ACN: 003 268 871
Summary of Use: For the prevention of heartworm disease and the treatment of roundworm, hookworm, whipworm and tapeworm (including hydatid tapeworm) in dogs up to 10 kg.
Date of Registration: 26 March 2002
Label Approval No: 55255/0302

Product Name: Friskies Tasty 6 Weekly Heartworm and Allwormer for Large Dogs
Active Constituent/s: 0.2 mg abamectin, 100 mg praziquantel, 450 mg oxibendazole
Applicant Name: Virbac (Australia) Pty Ltd
Applicant ACN: 003 268 871
Summary of Use: For the prevention of heartworm disease and the treatment of roundworm, hookworm, whipworm and tapeworm (including hydatid tapeworm) in dogs up to 20 kg.
Date of Registration: 26 March 2002
Label Approval No: 55256/0302

Product Name: Protech Bronchi-Shield 1 Bordetella Bronchiseptica Live Vaccine
Active Constituent/s: Bordetella bronchiseptica Live Vaccine
Applicant Name: Fort Dodge Australia Pty Limited
Applicant ACN: 000 074 902
Summary of Use: For the active immunisation by intranasal inoculation of healthy dogs over 3 weeks of age as an aid in preventing canine cough caused by Bordetella bronchiseptica.
Date of Registration: 27 March 2002
Label Approval No: 51823/0302

Product Name: Bob Martin Vetcare 5 Month Flea Collar for Dogs
Active Constituent/s: 150 g/kg diazinon
Applicant Name: Bob Martin (Australia) Pty Ltd
Applicant ACN: 062 627 883
Summary of Use: Flea collar for the control of fleas on dogs for up to 5 months.
Date of Registration: 2 April 2002
Label Approval No: 55590/0402

Product Name: Bob Martin Vetcare 5 Month Flea Collar for Cats
Active Constituent/s: 150 g/kg diazinon
Applicant Name: Bob Martin (Australia) Pty Ltd
Applicant ACN: 062 627 883
Summary of Use: Flea collar for the control of fleas on cats for up to 5 months.
Date of Registration: 2 April 2002
Label Approval No: 55588/0402

Product Name: Frontline Plus (Fipronil Plus (S)-Methoprene) for Cats
Active Constituent/s: 100 g/L fipronil, 120 g/L (S)-methoprene
Applicant Name: Merial Australia Pty Ltd
Applicant ACN: 071 187 285
Summary of Use: A 'spot-on' formulation containing fipronil and (s)-methoprene for treatment and control of fleas (all life cycle stages), brown dog ticks, biting lice and flea allergy dermatitis in kittens and cats.
Date of Registration: 5 April 2002
Label Approval No: 54524/0502

Product Name: Frontline Plus (Fipronil Plus (S)-Methoprene) for Dogs
Active Constituent/s: 100 g/L fipronil, 90 g/L (s)-methoprene
Applicant Name: Merial Australia Pty Ltd
Applicant ACN: 071 187 285
Summary of Use: A 'spot-on' formulation containing fipronil and (s)-methoprene for treatment and control of fleas (all life cycle stages), paralysis ticks, brown dog ticks, biting lice and flea allergy.
Date of Registration: 5 April 2002
Label Approval No: 54523/0502

Product Name: Protech Duramune C4+2I Canine Distemper, Adenovirus,Parainfluenza & Parvovirus Live Vaccine Plus Canine Coronavirus & Leptospira Icterohaemorrhagiae Killed Vaccine
Active Constituent/s: Canine distemper, adenovirus, parainfluenza & parvovirus live vaccine plus canine coronavirus and leptospira icterohaemorrhagiae killed vaccine
Applicant Name: Fort Dodge Australia Pty Limited
Applicant ACN: 000 074 902
Summary of Use: : For the immunisation of healthy dogs, 6 weeks of age or older to protect against disease caused by canine distemper virus, canine adenovirus type 1, adenovirus type 2, canine parainfluenza virus, canine parvovirus and Leptospira icterohaemorrhagiae and aid in protection against disease caused by canine coronavirus.
Date of Registration: 9 April 2002
Label Approval No: 51489/0302

Product Name: Protech Duramune C3+2I Canine Distemper, Adenovirus & Parvovirus Live Vaccine Plus Canine Coronavirus & Leptospira Icterohaemorrhagiae Killed Vaccine
Active Constituent/s: Canine distemper, adenovirus & parvovirus live vaccine plus canine coronavirus & Leptospira icterohaemorrhagiae killed vaccine
Applicant Name: Fort Dodge Australia Pty Limited
Applicant ACN: 000 074 902
Summary of Use: For the immunisation of healthy dogs, 6 weeks or older to protect against disease caused by canine distemper virus, canine adenovirus type 1, canine adenovirus type 2, canine parvovirus and Leptospira icterohaemorrhagiae and the aid in protection against disease caused by canine coronavirus. These vaccines can be used for the prevention of clinical disease, however they mail fail to prevent infection or organism shedding.
Date of Registration: 9 April 2002
Label Approval No: 51490/0302

Product Name: Walkabout Australian Made Itch-Free Antiseptic Lotion & Shampoo Bactericide & Fungicide
Active Constituent/s: 0.75 % iodine
Applicant Name: Rudducks Pty Ltd
Applicant ACN: 004 666 871
Summary of Use: A broad spectrum antiseptic treatment for dogs and cats.
Date of Registration: 9 April 2002
Label Approval No: 55600/0302

Product Name: Reptile Science Mite & Tick Spray for Snakes & Lizards
Active Constituent/s: 10 g/L piperonyl butoxide, 2 g/L permethrin
Applicant Name: Universal Manufacturing & Laboratories Pty Ltd
Applicant ACN: 010 668 729
Summary of Use: A spray for control of mites and ticks on snakes and lizards and reptile cages.
Date of Registration: 10 April 2002
Label Approval No: 55250/0302

Product Name: Avian Science Avicure Tetracycline
Active Constituent/s: 200 g/kg tetracycline hydrochloride
Applicant Name: Universal Manufacturing & Laboratories Pty Ltd
Applicant ACN: 010 668 729
Summary of Use: A broad spectrum antibiotic for the treatment of bacterial enteritis and diseases caused by tetracycline sensitive organisms in ornamental caged birds.
Date of Registration: 10 April 2002
Label Approval No: 55234/0102

Product Name: Exelpet Spot-On Flea Control for Cats and Kittens
Active Constituent/s: 100 g/L pyriproxyfen (10%)
Applicant Name: Exelpet Products (A Division of Effem Foods Pty Ltd)
Applicant ACN: 008 454 313
Summary of Use: Control of fleas on cats for 3 months.
Date of Registration: 10 April 2002
Label Approval No: 55481/0302

Product Name: V Diet Renal Programme RF 16
Active Constituent/s: 3.97 % essential fatty acids, 16 % fat, 2.4 % fibre, 16 % protein, 0.57 % calcium, 0.57 % chloride, 33 mg/kg copper sulfate, 0.7 % potassium, 0.06 % magnesium, 0.27 % sodium, 0.26 % phosphorus, 0.24 % sulfur, 4.4 % ash, 20,000 % vitamin A, 1,100 IU/kg vitamin D, 400 mg/kg vitamin E
Applicant Name: Premium Pet Food Imports Pty Ltd
Applicant ACN: 092 020 178
Summary of Use: Therapeutic pet food diet for dogs to support renal function in cases of chronic or temporary renal insufficiency, and to reduce oxalate urocystolithiasis.
Date of Registration: 11 April 2002
Label Approval No: 54488/0402

Product Name: V Diet Intestinal Programme GI 30
Active Constituent/s: 20 % fat, 2 % fibre, 30 % protein, 1 % calcium, 1.1 % chloride, 33 mg/kg copper sulfate, 0.8 % potassium, 0.5 % sodium, 0.8 % phosphorus, 6.5 % ash, 20,000 IU/kg vitamin A, 1,400 IU/kg vitamin D3, 400 mg/kg vitamin E
Applicant Name: Premium Pet Food Imports Pty Ltd
Applicant ACN: 092 020 178
Summary of Use: Therapeutic pet food diet for the reduction of acute intestinal absorptive disorders in dogs.
Date of Registration: 11 April 2002
Label Approval No: 54484/0402

Product Name: V Diet Urinary Programme Lp 20
Active Constituent/s: 0.03 % taurine, 20 % fat, 2 % fibre, 20 % protein, 0.70 % calcium, 1.5 % chloride, 32 mg/kg copper sulfate, 0.82 % potassium, 0.06 % magnesium, 0.36 % sodium, 0.52 % phosphorus, 0.29 % sulfur, 5.4 % ash, 20,000 IU/kg vitamin A, 1,400 IU/kg vitamin D3, 400 mg/kg vitamin E
Applicant Name: Premium Pet Food Imports Pty Ltd
Applicant ACN: 092 020 178
Summary of Use: Therapeutic pet food diet for dogs for the dissolution of calculi in cases of struvite urolithiasis.
Date of Registration: 11 April 2002
Label Approval No: 54490/0402

Product Name: V Diet Moderate Energy Programme AR 30
Active Constituent/s: 2.65 % essential fatty acids, 9.5 % fat, 15 % fibre, 30 % protein, 2.4 % sugars, 18.3 % starch, 0.84 % calcium, 32 mg/kg copper (cu) present as copper sulfate, 0.6 % phosphorus, 6.2 % ash, 22,000 IU/kg vitamin A, 1,900 IU/kg vitamin D3, 500 mg/kg vitamin E
Applicant Name: Premium Pet Food Imports Pty Ltd
Applicant ACN: 092 020 178
Summary of Use: Therapeutic pet food diet for dogs for the regulation of glucose supply in cases of diabetes mellitus and lipid metabolism in cases of hyperlipidaemia.
Date of Registration: 11 April 2002
Label Approval No: 54486/0402

Product Name: Metacam Anti-Inflammatory Injectable for Dogs and Cat
Active Constituent/s: 5 mg/mL meloxicam
Applicant Name: Boehringer Ingelheim Pty Ltd
Applicant ACN: 000 452 308
Summary of Use: A non-steroidal anti-inflammatory for use on dogs and cats.
Date of Registration: 12 April 2002
Label Approval No: 55529/0402

Product Name: V Diet Hypoallergenic Programme DR 21
Active Constituent/s: 4.47 % essential fatty acids, 19 % fat, 1.8 % fibre, 21 % protein, 1 % calcium, 32 mg/kg copper sulfate, 0.8 % phosphorus, 6.5 % ash, 30,000 IU/kg vitamin A, 1,100 IU/kg vitamin D3, 500 mg/kg vitamin E
Applicant Name: Premium Pet Food Imports Pty Ltd
Applicant ACN: 092 020 178
Summary of Use: Therapeutic pet food diet for dogs for the reduction of food intolerance.
Date of Registration: 15 April 2002
Label Approval No: 54482/0402

Product Name: V Diet Hypoallergenic Programme DR 25
Active Constituent/s: 4.76 % essential fatty acids, 20 % fat, 6 % fibre, 25.5 % protein, 0.9 % calcium, 33 mg/kg copper sulfate, 0.7 % phosphorus, 7 % ash, 30,000 IU/kg vitamin A, 1,100 IU/kg vitamin D3, 500 mg/kg vitamin E
Applicant Name: Premium Pet Food Imports Pty Ltd
Applicant ACN: 092 020 178
Summary of Use: Therapeutic pet food diet for cats for the reduction of food intolerance.
Date of Registration: 15 April 2002
Label Approval No: 54483/0402

Product Name: V Diet Moderate Energy Programme AR 37
Active Constituent/s: 2.94 % essential fatty acids, 9.8 % fat, 8 % fibre, 38 % protein, 20 % starch, 1 % calcium, 32 mg/kg copper sulfate, 1 % phosphorus, 8.2 % ash, 30,000 IU/kg vitamin A, 1,400 IU/kg vitamin D3, 500 mg/kg vitamin E
Applicant Name: Premium Pet Food Imports Pty Ltd
Applicant ACN: 092 020 178
Summary of Use: Therapeutic pet food diet for cats for the regulation of glucose supply in cases of diabetes mellitus and lipid metabolism in cases of hyperlipidaemia.
Date of Registration: 15 April 2002
Label Approval No: 54487/0402

Product Name: V Diet Urinary Programme LP 30
Active Constituent/s: 15 % fat, 5.3 % fibre, 30 % protein, 0.83 % calcium, 2.3 % chloride, 35 mg/kg copper sulfate, 1 % potassium, 0.08 % magnesium, 1 % sodium, 0.68 % phosphorus, 0.5 % sulpur, 0.18 % taurine, 7.7 % ash, 30,000 IU/kg vitamin A, 1,200 IU/kg vitamin D3, 500 mg/kg vitamin E
Applicant Name: Premium Pet Food Imports Pty Ltd
Applicant ACN: 092 020 178
Summary of Use: Therapeutic pet food diet for cats for the dissolution of calculi in cases of struvite urolithiasis.
Date of Registration: 16 April 2002
Label Approval No: 54491/0402

Product Name: V Diet Renal Programme RF 25
Active Constituent/s: 5.5 % essential fatty acids, 22 % fat, 6 % fibre, 25 % protein, 0.8 % calcium, 32 mg/kg copper sulfate, 0.3 % sodium, 0.5 % phosphorus, potassium 0.9 %, 6.3 % ash, 30,000 IU/kg vitamin A, 1,200 IU/kg vitamin D, 500 mg/kg vitamin E
Applicant Name: Premium Pet Food Imports Pty Ltd
Applicant ACN: 092 020 178
Summary of Use: Therapeutic pet food diet for cats to support renal function in cases of chronic or temporary renal insufficiency, and to reduce oxalate urocystolithiasis.
Date of Registration: 16 April 2002
Label Approval No: 54489/0402

Product Name: V Diet Intestinal Programme GI 32
Active Constituent/s: 22 % fat, 5.1 % fibre, 32 % protein, 1 % calcium, 32 mg/kg copper sulfate, 1 % potassium, 0.45 % sodium, 1 % phosphorus, 7.6 % ash, 30,000 IU/kg vitamin A, 1,200 IU/kg vitamin D3, 500 mg/kg vitamin E, taurine 0.22%
Applicant Name: Premium Pet Food Imports Pty Ltd
Applicant ACN: 092 020 178
Summary of Use: Therapeutic pet food diet for the reduction of acute intestinal absorptive disorders in cats.
Date of Registration: 17 April 2002
Label Approval No: 54485/0402

Product Name: Atopica 25 MG Soft Capsules for Dogs
Active Constituent/s: Each capsule contains 25 mg cyclosporin
Applicant Name: Novartis Animal Health Australasia Pty Limited
Applicant ACN: 076 745 198
Summary of Use: For the treatment of atopic dermatitis in dogs.
Date of Registration: 18 April 2002
Label Approval No: 54355/0402

Product Name: Atopica 10 MG Soft Capsules for Dogs
Active Constituent/s: Each capsule contains 10 mg cyclosporin
Applicant Name: Novartis Animal Health Australasia Pty Limited
Applicant ACN: 076 745 198
Summary of Use: For the treatment of atopic dermatitis in dogs.
Date of Registration: 18 April 2002
Label Approval No: 54354/0402

Product Name: Atopica 100 MG Soft Capsules for Dogs
Active Constituent/s: Each capsule contains 100 mg cyclosporin
Applicant Name: Novartis Animal Health Australasia Pty Limited
Applicant ACN: 076 745 198
Summary of Use: For the treatment of atopic dermatitis in dogs.
Date of Registration: 18 April 2002
Label Approval No: 54357/0402

3. VARIATIONS

Product Name: Paramectin RV Pour-On for Cattle
Applicant Name: Jurox Pty Limited
Applicant ACN: 000 932 230
Summary of Variation: Extension of claims for use to include control of buffalo fly (Haematobia irritans exigua).
Date of Variation: 9 April 2002
Label Approval No: 53549/0302

Product Name: Metacam Anti-Inflammatory Injectable for Dogs
Applicant Name: Boehringer Ingelheim Pty Ltd
Applicant ACN: 000 452 308
Summary of Variation: Approval of extension to use to include cats.
Date of Variation: 12 April 2002
Label Approval No: 49656/0302

Product Name: Cydectin Pour-On for Cattle and Red Deer
Applicant Name: Fort Dodge Australia Pty Limited
Applicant ACN: 000 074 902
Summary of Variation: Extension of claims to Cooperia pectinata, Nematodirus helvetianus and Trichuris spp. 21 days persistent protection period against Nematodirus helvetianus.
Date of Variation: 19 April 2002
Label Approval No: 45970/0402