Gazette APVMA 9, 6 September 2005 page 12

NOTICE OF REGISTRATION OF AGRICULTURAL AND VETERINARY CHEMICAL PRODUCTS

Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has registered or varied the registration in respect of the following products, with effect from the dates shown.

VETERINARY CHEMICAL PRODUCTS

1. RESTRICTED PRODUCT:

“No Entries”

2. VETERINARY PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS:

“No Entries”

3. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS:

Product Name: Duramune Adult C3 Canine Distemper, Adenovirus & Parvovirus Live Vaccine
Active Constituent/s: Duramune Adult C3 Canine Distemper, Adenovirus & Parvovirus Live Vaccine is prepared from attenuated canine distemper virus (onderstepoort strain, 10 2.46 TCID50), canine
adenovirus type 2 (CAV-V197 strain, 10 4.8 TCID50)
and canine parvovirus (SAH-CPV-2b strain, 10 5.5 TCID50) grown on continuous cell lines.
Applicant Name: Fort Dodge Australia Pty
Limited
Applicant ACN: 000 074 902
Summary of Use: For immunization of healthy dogs, 6 weeks of age or older to protect against disease caused by canine distemper virus, canine adenovirus type 1, canine adenovirus type 2 and canine parvovirus.
Date of Registration: 25 July 2005
Label Approval No: 59730/25/0405, 59730/10/0405, 59730/0405

Product Name: Duramune Adult C4 Canine Distemper, Adenovirus, Parainfluenza & Parvovirus Live Vaccine
Active Constituent/s: Duramune Adult C4 Canine Distemper, Adenovirus, Parainfluenza & Parvovirus Live Vaccine is prepared from attenuated canine distemper virus (onderstepoort strain, 10 2.46 TCID50), canine adenovirus type 2 (CAV2-V197 strain, 10 4.8 TCID50), canine parvovirus (SAH-CPV-2b strain, 10 5.5 TCID50) and canine parainfluenza Type 2 (10 4.55 TCID50) grown on continuous cell lines
Applicant Name: Fort Dodge Australia Pty Limited
Applicant ACN: 000 074 902
Summary of Use: For immunization of healthy dogs, 6 weeks of age or older to protect against disease caused by canine distemper virus, canine adenovirus type 1, canine adenovirus type 2 and canine parvovirus.
Date of Registration: 25 July 2005
Label Approval No: 59731/25/0405, 59731/10/0405, 59731/0405

Product Name: Oodonex by Aquasonic
Active Constituent/s: Each mL of solution
contains 0.24 mg aminacrine hydrochloride,
5.4 mg copper as copper sulfate
Applicant Name: Aquasonic Pty Ltd
Applicant ACN: 001 427 256
Summary of Use: Aquarium antiseptic to aid in the control of oodinium and white spot in marine fish.
Date of Registration: 13 July 2005
Label Approval No: 57854/100mL/0704, 57854/250mL/0704, 57854/1L/0704

Product Name: Bactonex by Aquasonic
Active Constituent/s: Each mL of solution contains 0.025 mg methylene blue, 1.66 mg aminacrine hydrochloride
Applicant Name: Aquasonic Pty Ltd
Applicant ACN: 001 427 256
Summary of Use: A preparation which assists in the prevention of bacterial, fungal and parasitic diseases in fresh water and saltwater fish.
Date of Registration: 14 July 2005
Label Approval No: 57893/100mL/0704, 57893/250mL/0704, 57893/1L/0704

Product Name: Vertonex Antiprotozoal Solution by Aquasonic
Active Constituent/s: Each mL of solution contains 30 mg quinine hydrochloride, 3.8 mg malachite green
Applicant Name: Aquasonic Pty Ltd
Applicant ACN: 001 427 256
Summary of Use: A disinfectant and anti-protozooal product for the treatment of parasitic diseases in ornamental marine aquarium fish.
Date of Registration: 14 July 2005
Label Approval No: 57851/50mL/0704, 57851/100mL/0704, 57851/250mL/0704, 57851/1L/0704

Product Name: Roedoxx Tablets
Active Constituent/s: Each tablet contains 100 mg doxycycline (as doxycycline monohydrate)
Applicant Name: Cipla Ltd
Summary of Use: For treatment of infections caused by organisms sensitive to doxycycline in large dogs.
Date of Registration: 14 July 2005
Label Approval No: 58853/100/0904, 58853/0904

Product Name: Equis Fre-Itch Cooling Medicated Shampoo for Horses
Active Constituent/s: 4 g/L cresol, 2 g/L cetrimide
Applicant Name: Mavlab Pty. Ltd.
Applicant ACN: 009 708 187
Summary of Use: Medicated shampoo to be used as an aid in the treatment of non-specific dermatological conditions of horses.
Date of Registration: 18 July 2005
Label Approval No: 59242/250/0505, 59242/500/0505, 59242/2L/0505

Product Name: Cephalexin 1000 Antibiotic Tablets
Active Constituent/s: Each tablet contains 1000 mg cephalexin (as cephalexin monohydrate)
Applicant Name: Apex Laboratories Pty Ltd
Applicant ACN: 000 397 240
Summary of Use: For the treatment of infections in large dogs caused by micro-organisms sensitive to cephalexin.
Date of Registration: 21 July 2005
Label Approval No: 59249/100/0505

Product Name: I Love My Pet Bird Mite & Lice Spray
Active Constituent/s: 5 g/L piperonyl butoxide, 0.5 g/L pyrethrins
Applicant Name: My Pet Products Australia Pty. Ltd.
Applicant ACN: 068 507 148
Summary of Use: Bird mite and lice spray for the control of feather mites and lice on caged birds.
Date of Registration: 21 July 2005
Label Approval No: 59306/125/0205, 59306/250/0205, 59306/500/0205

Product Name: NV Haemo Injection
Active Constituent/s: 20 mg/mL glycine, 20 mg/mL L-lysine HCl, 20 mg/mL methionine-DL, 240 μg/mL cobalt sulfate, 70 μg/mL copper sulfate, 15 mg/mL ammonium ferric citrate, 10 μg/mL biotin, 10 mg/mL choline bitartrate, 10 mg/mL inositol, 150 μg/mL cyanocobalamin, 100 mg/mL nicotinamide, 15 mg/mL D-pantothenol, 10 mg/mL riboflavin, 10 mg/mL pyridoxine HCl
Applicant Name: Nature Vet Pty Limited
Applicant ACN: 002 692 426
Summary of Use: For the supplementation of vitamins, amino acids and minerals to horses, cattle and dogs.
Date of Registration: 21 July 2005
Label Approval No: 59984/100ML1/0605, 59984/100ML2/0605

Product Name: RWR Tissue Repair Oily Injection
Active Constituent/s: 80 mg/mL nandrolone decanoate, 1.30 mg/mL oestradiol dipropionate, 80 mg/mL hydroxy progesterone hexanoate
Applicant Name: RWR Veterinary Products Pty Ltd
Applicant ACN: 088 423 018
Summary of Use: A depot antibiotic steroid with moderate androgenic effect for the use in horses to aid bone and tissue repair.
Date of Registration: 21 July 2005
Label Approval No: 59787/10ML/0505

Product Name: Duramune Adult C4 Canine Distemper, Adenovirus, Parainfluenza & Parvovirus Live Vaccine
Active Constituent/s: Duramune Adult C4 Canine Distemper, Adenovirus, Parainfluenza & Parvovirus Live Vaccine is prepared from attenuated canine distemper virus (onderstepoort strain, 10 2.46 TCID50), canine adenovirus type 2 (CAV2-V197 strain, 10 4.8 TCID50), canine parvovirus (SAH-CPV-2b strain, 10 5.5 TCID50) and canine parainfluenza Type 2 (10 4.55 TCID50) grown on continuous cell lines
Applicant Name: Fort Dodge Australia Pty Limited
Applicant ACN: 000 074 902
Summary of Use: For immunisation of healthy dogs, 6 weeks of age or older to protect against disease caused by canine distemper virus, canine adenovirus type 1, canine adenovirus type 2 and canine parvovirus.
Date of Registration: 25 July 2005
Label Approval No: 59731/25/0405, 59731/10/0405, 59731/0405

Product Name: Duramune Adult C3 Canine Distemper, Adenovirus & Parvovirus Live Vaccine
Active Constituent/s: Duramune Adult C3 Canine Distemper, Adenovirus & Parvovirus Live Vaccine is prepared from attenuated canine distemper virus (onderstepoort strain, 10 2.46 TCID50), canine adenovirus type 2 (CAV-V197 strain, 10 4.8 TCID50) and canine parvovirus (SAH-CPV-2b strain, 10 5.5 TCID50)
grown on continuous cell lines
Applicant Name: Fort Dodge Australia Pty
Limited
Applicant ACN: 000 074 902
Summary of Use: For immunisation of healthy dogs, 6 weeks of age or older to protect against disease caused by canine distemper virus, canine adenovirus type 1, canine adenovirus type 2 and canine parvovirus.
Date of Registration: 25 July 2005
Label Approval No: 59730/25/0405, 59730/10/0405, 59730/0405

Product Name: Ranvet's Worm Free Allwormer for Dogs
Active Constituent/s: Each tablet contains 542 mg oxantel embonate, 143 mg pyrantel embonate, 50 mg praziquantel.
Applicant Name: Ranvet Pty. Limited
Applicant ACN: 001 606 033
Summary of Use: For the treatment of gastrointestinal worms in dogs.
Date of Registration: 27 July 2005
Label Approval No: 59582/25/0305, 59582/50/0305, 59582/100/0305

Product Name: Ranvet's Worm Free Allwormer for Large Dogs
Active Constituent/s:Each tablet contains 1355 mg oxantel embonate, 357.5 mg pyrantel embonate,
125 mg praziquantel
Applicant Name: Ranvet Pty. Limited
Applicant ACN: 001 606 033
Summary of Use: For the treatment of gastrointertinal worms in large dogs.
Date of Registration: 27 July 2005
Label Approval No: 59581/25/0305, 59581/50/0305, 59581/100/0305

Product Name: Para-Gone Antiparasitic Tablets by Aquasonic
Active Constituent/s: Each tablet contains 32 mg trichlorfon
Applicant Name: Aquasonic Pty Ltd
Applicant ACN: 001 427 256
Summary of Use: An anticholinesterase compound for the treatment of parasitic infestations in ornamental aquarium fish.
Date of Registration: 27 July 2005
Label Approval No: 58285/25/0704, 58285/100/0704, 58285/300/0704

Product Name: Para-Gone Antiparasitic Tablets by Aquasonic
Active Constituent/s: 32 mg trichlorfon
Applicant Name: Aquasonic Pty Ltd
Applicant ACN: 001 427 256
Summary of Use: An anticholinesterase compound for the treatment of parasitic infestations in ornamental aquarium fish.
Date of Registration: 27 July 2005
Label Approval No: 58285/25/0704, 58285/100/0704, 58285/300/0704

Product Name: Equiwormer Oral Broad Spectrum Parasite Control for Horses
Active Constituent/s: 3.70 mg/g abamectin
Applicant Name: Aussie Veterinary Supplies Pty
Ltd
Applicant ACN: 060 417 352
Summary of Use: For the treatment and control of roundworms, bots, and skin lesions caused by summer sores and cutaneous onchocerciasis in horses.
Date of Registration: 29 July 2005
Label Approval No: 58246/32.4/0104

Product Name: Equiwormer Plus Tape Oral Paste for Horses
Active Constituent/s: 3.7 mg/g abamectin, 46.2 mg/g praziquantel
Applicant Name: Aussie Veterinary Supplies Pty Ltd
Applicant ACN: 060 417 352
Summary of Use: For treatment and control of tapeworms and roundworms, bots and skin lesions caused by Habronema, Draschia and Onchocerca spp. in horses.
Date of Registration: 2 August 2005
Label Approval No: 58236/32.4/0504

Product Name: Fenpral Intestinal Worming Paste for Cats
Active Constituent/s: Each mL contains 300 mg/g niclosamide as the monohydrate
Applicant Name: Riverside Veterinary Products Pty. Limited
Applicant ACN: 059 860 589
Summary of Use: Worming paste for the control of roundworms, hookworms and tapeworms in cats.
Date of Registration: 8 August 2005
Label Approval No: 57801/5mL/0405, 57801/0405

Product Name: Bay-O-Pet Drontal Allwormer Chewable for Large Dogs Controls all 11 Gastrointestinal Worms
Active Constituent/s: Each chewable contains 174.4 mg pyrantel as pyrantel embonate, 175 mg praziquantel, 875 mg febantel
Applicant Name: Bayer Australia Ltd
Applicant ACN: 000 138 714
Summary of Use: For the treatment and control of gastrointestinal worms in large dogs.
Date of Registration: 10 August 2005
Label Approval No: 59289/2/0705, 59289/20/0705

Product Name: Bay-O-Pet Drontal Allwormer Chewable for Dogs Controls all 11 Gastrointestinal Worms
Active Constituent/s: Each chewable contains 49.8 mg pyrantel as pyrantel embonate, 50 mg praziquantel, 250 mg febantel.
Applicant Name: Bayer Australia Ltd
Applicant ACN: 000 138 714
Summary of Use: For the treatment and control of gastrointestinal worms in dogs.
Date of Registration: 10 August 2005
Label Approval No: 59292/2/0705, 59292/5/0705, 59292/20/0705

Product Name: Rumi-Buff Natural Ruminant Buffer Based on Calcified Seaweed
Active Constituent/s: 803.5 g/kg calcium carbonate, 126 g/kg magnesium carbonate
Applicant Name: Rabar Pty. Ltd.
Applicant ACN: 010 969 776
Summary of Use: A calcified seaweed food additive to be used as a slow release for ruminants.
Date of Registration: 11 August 2005
Label Approval No: 59355/25/0705

Product Name: Vetbasix Puppy & Kitten Worm Syrup
Active Constituent/s: 100 mg/mL piperazine citrate
Applicant Name: Rudducks Pty Ltd
Applicant ACN: 004 666 871
Summary of Use: A pleasant tasting worm syrup for the removal of roundworms in puppies and kittens.
Date of Registration: 11 August 2005
Label Approval No: 59168/30ML/0105, 59168/50ML/0105

4.VARIATIONS

Product Name: Dectomax Pour-On Endectocide
Applicant Name: Pfizer Australia Pty Ltd
Applicant ACN: 008 422 348
Summary of Variation: Extension of use to include dairy cattle.
Date of Variation: 15 July 2005
Label Approval No: 49665/2.5L/0605, 49665/5L/0605, 49665/0605

5.. RESTRICTED PRODUCT VARIATION

“No Entries”