Gazette APVMA 5, 3 May 2005 page 9

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:

Product Name:
Active Constituent/s:
Applicant Name:
Applicant ACN:
Summary of Use:
Date of Registration:
Label Approval No:

“No Entries”

2. VETERINARY PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS:

Product Name:
Active Constituent/s:
Applicant Name:
Applicant ACN:
Summary of Use:
Date of Registration:
Label Approval No:

“No Entries”

3. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS:

Product Name:
Active Constituent/s:
Applicant Name:
Applicant ACN:
Summary of Use:
Date of Registration:
Label Approval No:

Product Name: Prostamate (Dinoprost Trometamol Injection)
Active Constituent/s: 5 mg/mL dinoprost as dinoprost trometamol
Applicant Name: Phoenix Scientific Inc
Summary of Use: An injectable prostaglandin F2α for use as an aid in the control of reproduction in cattle, horses and pigs.
Date of Registration: 22 March 2005
Label Approval No: 58540/30ML/0704

Product Name: Amoxysol Amoxycillin Trihydrate Soluble Powder
Active Constituent/s: 853 g/kg amoxycillin (as the trihydrate)
Applicant Name: Anzchem Pty Limited
Applicant ACN: 103 260 215
Summary of Use: Broad spectrum antibiotic for administration in drinking water for treatment of infections of chickens caused by organisms sensitive to amoxyicillin.
Date of Registration: 22 March 2005
Label Approval No: 58842/25kg/0305

Product Name: Phibrobac 150 Feed Additive Premix
Active Constituent/s: 150 g/kg bacitracin zinc
Applicant Name: Phibro Animal Health Pty Ltd
Applicant ACN: 093 869 991
Summary of Use: For the treatment of Necrotic Enteritis (Clostridium Perfeingens Types A and C)
and as a growth promotant.
Date of Registration: 23 March 2005
Label Approval No: 58388/25/0205

Product Name: Tylopharm Soluble Tylosin Tartrate Soluble Powder
Active Constituent/s: 800 g/kg tylosin as tartrate
Applicant Name: Pharmtech Pty Limited
Applicant ACN: 084 248 206
Summary of Use: For use in drinking water as an aid in the prevention and treatment of chronic respiratory disease in broilers and replacemnet chickens, infectious sinusitis in turkeys and swine dysentery in pigs.
Date of Registration: 29 March 2005
Label Approval No: 59362/100g/0405, 59362/1kg/0405, 59362/10kg/0405

Product Name: Advantix For Dogs 10-25kg
Active Constituent/s: 100 g/L imidacloprid, 500 g/L permethrin (40:60)
Applicant Name: Bayer Australia Ltd (Animal Health)
Applicant ACN: 000 138 714
Summary of Use: Spot on ectoparasiticide product for use on dogs between 10 - 25kg. The product controls ticks including the paralysis tick, brown dog tick, and bush tick and is also for the treatment and prevention of fleas, reducing the incidence of Flea Allergy Dermatitis. Additionally, larval flea stages are killed in the surroundings of treatesd pets, lice are controlled for up to 6 weeks and mosquitoes and sandflies are repelled and killed.
Date of Registration: 30 March 2005
Label Approval No: 58260/1004, 58260/1/1004, 58260/3/1004, 58260/6/1004, leaflet

Product Name: Nobilis Gumboro + ND Combined Inactivated Vaccine Against Gumboro And Newcastle Disease
Active Constituent/s: NVD clone 30 inducing > 4 log2 HI units per 1/50th of a dose or containing >50 PD50 units/dose; IBDV D78: inducing > 14.5log2 VN units/dose in an oil adjuvanted emulsion.
Applicant Name: Intervet Australia Pty Limited
Applicant ACN: 008 467 034
Summary of Use: Inactivated vaccine for the protection of chickens against Infectous Bursal Disease and poultry against Newcastle Disease
Date of Registration: 31 March 2005
Label Approval No: 58353/1000D/1204, 58353/1204

Product Name: Advantix For Dogs Over 25kg
Active Constituent/s: 100 g/L imidacloprid, 500 g/L permethrin (40:60)
Applicant Name: Bayer Australia Ltd (Animal Health)
Applicant ACN: 000 138 714
Summary of Use: Spot on ectoparasiticide product for use on dogs over 25 kg. The product controls ticks including the paralysis tick, brown dog tick, and bush tick and is also for the treatment and prevention of fleas, reducing the incidence of Flea Allergy Dermatitis. Additionally, larval flea stages are killed in the surroundings of treated pets, lice are controlled for up to 6 weeks and mosquitoes and sandflies are repelled and killed.
Date of Registration: 4 April 2005
Label Approval No: 58262/1004, 58262/1/1004, 58262/3/1004, 58262/6/1004, leaflet

Product Name: Advantix For Dogs 4-10kg
Active Constituent/s: 100 g/L imidacloprid, 500 g/L permethrin (40:60)
Applicant Name: Bayer Australia Ltd (Animal Health)
Applicant ACN: 000 138 714
Summary of Use: Spot on ectoparasiticide product for use on dogs between 4 - 10 kg. The product controls ticks including the paralysis tick, brown dog tick, and bush tick and is also for the treatment and prevention of fleas, reducing the incidence of Flea Allergy Dermatitis. Additionally, larval flea stages are killed in the surroundings of treated pets, lice are controlled for up to 6 weeks and mosquitoes and sandflies are repelled and killed.
Date of Registration: 4 April 2005
Label Approval No: 58261/1004, 58261/1/1004, 58261/3/1004, 58261/6/1004, leaflet

Product Name: Y-Tex Python Maxima Insecticidal Cattle Ear Tag
Active Constituent/s: 200 g/kg piperonyl butoxide, 100 g/kg zeta-cypermethrin
Applicant Name: Flycam Pty Ltd
Applicant ACN: 310 625 216
Summary of Use: Ear tag product for the control of buffalo flies and as an aid in control of cattle biting lice and nuisance flies on beef and dairy cattle.
Date of Registration: 4 April 2005
Label Approval No: 57920/20T/0305, 57920/100T/0305, 57920/500T/0305, 57920/0305

Product Name: Tildren Injection
Active Constituent/s: 56.91 mg/vial tiludronic acid as disodium tiludronate
Applicant Name: Ceva Sante Animale S.A
Summary of Use: An intravenous injection for horses, containing an active ingredient belonging to the bisphosphonate class, which inhibits the resorption of bone and so regulates bone remodeling when excessive bone resorption occurs.
Date of Registration: 4 April 2005
Label Approval No: 58057/10/0205

Product Name: Worm-It Broad Spectrum Worm And Bot Paste For Horses
Active Constituent/s: 3.64 mg/g abamectin
Applicant Name: Kelato Animal Health A Div Of Evolution Animal Health PL
Applicant ACN: 006 357 366
Summary of Use: For the treatment and control of roundworms, bots and nematodes for horses.
Date of Registration: 6 April 2005
Label Approval No: 58146/33/0204, 58146/1/0204, 58146/2/0204

Product Name: Go-Pet Spot-On Flea Control For Cats And Kittens
Active Constituent/s: 100 g/L pyriproxyfen
Applicant Name: Go-Pet Petcare Solutions A Div Of Nestle Australia Ltd
Applicant ACN: 000 011 316
Summary of Use: For the control of fleas in cat by preventing adult fleas from producing viable eggs and arresting flea larval development for 3 months.
Date of Registration: 8 April 2005
Label Approval No: 59505/1/0105

Product Name: Aristopet Worm-Enda Poultry Wormer
Active Constituent/s: 8.48 g/L levamisole (present as levamisole hydrochloride)
Applicant Name: Aristopet Pty Ltd
Applicant ACN: 009 697 152
Summary of Use: For the treatment of levimisole-sensitive large roundworm, caecal worm and hairworm in fowls, turkeys and other food producing birds.
Date of Registration: 8 April 2005
Label Approval No: 59127/125/0305

Product Name: Go-Pet Spot-On Flea Control For Cats And Kittens
Active Constituent/s: 100 g/L pyriproxyfen
Applicant Name: Go-Pet Petcare Solutions A Div Of Nestle Australia Ltd
Applicant ACN: 000 011 316
Summary of Use: For the control of fleas in cats by preventing adult fleas from producing viable eggs and arresting flea larval development for 3 months.
Date of Registration: 8 April 2005
Label Approval No: 59505/1/0105

Product Name: FGA-30 Vaginal Sponge
Active Constituent/s: 30 mg per sponge flugestone acetate
Applicant Name: Pharmplex Pty Ltd
Applicant ACN: 005 368 614
Summary of Use: Vaginal sponges indicated for oestrus induction in adult sheep.
Date of Registration: 11 April 2005
Label Approval No: 56278/25S(0205), 56278

Product Name: Avi-Care The Science Of Bird Care Scale Barrier
Active Constituent/s: 75 g/L benzyl benzoate
Applicant Name: Rudducks Pty Ltd
Applicant ACN: 004 666 871
Summary of Use: For the treatment of Scaly Face and Scaly Leg caused by the parasite Cnemidocoptes pilae in budgerigars, canaries, finches and parrots.
Date of Registration: 11 April 2005
Label Approval No: 58707/50/1004

Product Name: RWR 4 Fillies Oily Anabolic Injection For Fillies And Mares
Active Constituent/s: 45 mg/mL methandriol dipropionate, 30 mg/mL nandrolone phenylpropionate
Applicant Name: RWR Veterinary Products Pty Ltd
Applicant ACN: 088 423 018
Summary of Use: An anabolic steroid with low androgenic effect for horses.
Date of Registration: 12 April 2005
Label Approval No: 59360/10ML/1004

Product Name: Ultravac Botulinum Vaccine
Active Constituent/s: Cl. Botulinum type C,
Cl. Botulinum type D toxoids
Applicant Name: Pfizer Animal Health
A Division of Pfizer Australia Pty Ltd
Applicant ACN: 008 422 348
Summary of Use: For the prevention of
botulism in cattle and sheep.
Date of Registration: 13 April 2005
Label Approval No: 59537/1/1204,
59537/2/1204, 59537/3/1204, 59537/4/1204,
59537/1204

Product Name: Gastrozol Daily Oral Paste For Horses
Active Constituent/s: 50 mg/mL omeprazole
Applicant Name: Metelli Pty Ltd As Trustee For Axon Animal Health Trust
Applicant ACN: 103 996 390
Summary of Use: An oral paste for the treatment and prevention of gastric ulcers in horses.
Date of Registration: 13 April 2005
Label Approval No: 58757/30mL/0405

4.VARIATIONS

Product Name:
Applicant Name:
Applicant ACN:
Summary of Variation:
Date of Variation:
Label Approval No:

“No Entries”

5.. RESTRICTED PRODUCT VARIATION

Product Name:
Applicant Name:
Applicant ACN:
Summary of Variation:
Date of Variation:
Label Approval No:

“No Entries”