Gazette APVMA 6, 7 June 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: 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 remodelling when excessive bone resorption occurs.
Date of Registration: 4 April 2005
Label Approval No: 58057/10/0205

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

Product Name: Aquatopia Australia Multi-Fix Broad Spectrum Medication
Active Constituent/s: 4 mg/mL methylene blue, 2 mg/mL acriflavine, 0.40 mg/mL malachite green
Applicant Name: Aquatopia Australia Pty Ltd
Applicant ACN: 101 954 938
Summary of Use: Aids in the treatment of white spot, velvet disease and fungal diseases in aquarium fish.
Date of Registration: 14 April 2005
Label Approval No: 59122/2/1004, 59122/50/1004, 59122/125/1004, 59122/250/1004, 59122/500/1004

Product Name: Guardian Complete Worming Chew Monthly Heartworm and Intestinal Allwormer for Dogs
Active Constituent/s: Each chew contains 60 µg ivermectin, 543 mg oxantel embonate (equivalent to 194.2 mg oxantel), 143 mg pyrantel embonate (equivalent to 49.6 mg pyrantel), 50 mg praziquantel.
Applicant Name: Schering-Plough Pty Limited
Applicant ACN: 000 235 245
Summary of Use: A monthly chewable tablet for the prevention of heartworm infection and the control of roundworms, whipworms, hookworms and tapeworms (including hydatid tapeworms) in dogs.
Date of Registration: 18 April 2005
Label Approval No: 58819/4/1204, 58819/8/1204, 58819/12/1204, 58819/16/1204,58819/20/1204, 58819/24/1204, 58819/72/1204, foil

Product Name: AAH Chloramine T Fungicide Disinfectant
Active Constituent/s: 1000 g/kg chloramine
Applicant Name: Goodwale Pty Ltd T/A Allied Animal Health
Applicant ACN: 003 939 339
Summary of Use: A fungicide disinfectant to assist in the disinfection of wounds, obstetrical procedures, animal housing and food producing animal equipment.
Date of Registration: 19 April 2005
Label Approval No: 59342/2kg/0205, 59342/5kg/0205, 59342/10kg/0205, 59342/20kg/0205, 59342/25kg/0205

Product Name: Nobilis EDS + ND Combined Inactivated Vaccine Against EDS'76 and Newcastle Disease
Active Constituent/s: EDS’76 virus BC14: including ≥ 6.5 log2 HI unites per dose; NDV Clone 30: including ≥4 log2 HI units per 1/50th dose or containing ≥ 50 PD log50 units per dose, in oil adjuvant emulsion.
Applicant Name: Intervet Australia Pty Limited
Applicant ACN: 008 467 034
Summary of Use: Combined inactivated vaccine against EDS’76 and Newcastle Disease.
Date of Registration: 20 April 2005
Label Approval No: 58494/1000D/1104, 58494/1104

Product Name: Poulvac Newcastle IK Vaccine (Inactivated)
Active Constituent/s: Newcastle disease virus LaSota strain (inactivated). Each dose contain no less than 107.8 EID50 Newcastle virus
Applicant Name: Fort Dodge Australia Pty Limited
Applicant ACN: 000 074 902
Summary of Use: For intramuscular or subcutaneous vaccination of healthy chickens 3 weeks of age or older, as an aid in the prevention of newcastle disease.
Date of Registration: 22 April 2005
Label Approval No: 59138/500mL/0305

Product Name: Obesity with Beef
Applicant Name: Royal Canin Australia Pty Ltd
Applicant ACN: 092 020 178
Summary of Use: Complete diet intended for the reduction of excessive body weight in cats
Date of Registration: 27 April 2005
Label Approval No: 58593/100/1104, 58593/100C/1104

Product Name: Urinary with Chicken
Applicant Name: Royal Canin Australia Pty Ltd
Applicant ACN: 092 020 178
Summary of Use: Complete diet intended for the dissolution of struvite stones and the reduction of struvite stone recurrence.
Date of Registration: 27 April 2005
Label Approval No: 58592/100/1104, 58592/100C/1104

Product Name: Renal with Chicken
Applicant Name: Royal Canin Australia Pty Ltd
Applicant ACN: 092 020 178
Summary of Use: Complete diet intended for the support of renal function in case of chronic renal insufficiency.
Date of Registration: 27 April 2005
Label Approval No: 58591/100/1104, 58591/100C/1104

Product Name: Sensitivity Control Chicken with Rice
Applicant Name: Royal Canin Australia Pty Ltd
Applicant ACN: 092 020 178
Summary of Use: A complete diet for cats, which is intended as an aid in reducing ingredient and nutrient intolerances.
Date of Registration: 27 April 2005
Label Approval No: 58776/100/1104, 58776/100C/1104

Product Name: Pet Care Australia's Concentrate Wash For Fleas Ticks and Lice
Active Constituent/s: 5 g/L N-octyl bicycloheptene dicarboximide, 18 g/L piperonyl butoxide, 10 g/L pyrethrum.
Applicant Name: Nebaj Nominee Pty Ltd T/A Kanine Nutrition
Applicant ACN: 008 838 015
Summary of Use: A pet wash concentrate for the control of fleas and lice on dogs, puppies, cats, and kittens. The product also aids in the control of adult brown ticks, for up to seven days but does not control paralysis tick. The product also controls lice and biting lice on caged birds and in aviaries.
Date of Registration:28 April 2005
Label Approval No: 47752/250ml/1004, 47752/500ml/1004, 47752/1L/1004, 47752/5L/1004, 47752/10L/1004, 47752/20L/1004

Product Name: Noroclox LC Lactating Cow Intramammary Antibiotic Infusion with Prolonged Action
Active Constituent/s: Each 3g syringe contains 200 mg cloxacillin as the benzathine salt, 25 mg brilliant blue FCF
Applicant Name: Norbrook Laboratories Australia Pty Limited
Applicant ACN: 080 972 596
Summary of Use: For the treatment of mastitis in lactating cows caused by organisms sensitive to cloxacillin.
Date of Registration: 2 May 2005
Label Approval No: 58491/20/0205, 58491/0205

Product Name: Imax CD Pour-On for Cattle
Active Constituent/s: 10 mg/mL ivermectin
Applicant Name: Pharmtech Pty Limited
Applicant ACN: 084 248 206
Summary of Use: For the treatment and control of ivermectin sensitive nematodes and external parasites of beef and dairy cattle.
Date of Registration: 3 May 2005
Label Approval No: 59344/500mL/0305, 59344/2.5L/0305, 59344/10L/0305

Product Name: Quantum Phytase 5000 L
Active Constituent/s: Each 1L contains 6-phytase (from pichia pastoris) 5000 FTU/g
Applicant Name: Syngenta Seeds Pty Limited
Applicant ACN: 001 302 254
Summary of Use: A liquid source of phytase to be used to improve the utilisation of phosphorous in poultry and pig feeds.
Date of Registration: 9 May 2005
Label Approval No: 58962/200L/0405, 58962/1000L/0405

Product Name: Allzyme SSF
Active Constituent/s: Alpha-amylase (min.30 FAU/g), Beta-glucanase (min. 200 BGU/g), Celluase (min.10 CMC/g), Pectinase (min. 4000 AJDU/g), Phytase (300 SPU/g), Fungal Protease (min. 700 HUT/g), Xylanase (min. 100 XU/g) delivered from Aspergillus niger.
Applicant Name: Alltech Biotechnology Pty
Limited
Applicant ACN: 075 560 584
Summary of Use: An enzyme complex for
improving the bioavailability of phosphorous,
calcium, energy and amino acids in poultry and pig feeds based on cereal grains or oil seeds.
Date of Registration: 12 May 2005
Label Approval No: 58860/25kg/0105

Product Name: Phyzyme XP 5000G
Active Constituent/s: Each 1kg contains 6-phytase (from Schizosaccharomyces pombe) 5000 FTU/g
Applicant Name: Finnfeeds International Ltd (UK)
Summary of Use: A source of phytase to be used to improve the utilisation in poultry and pig feeds.
Date of Registration: 13 May 2005
Label Approval No: 59295/25kg/0505

Product Name: Defiance's' Aerosol Insecticidal Flystrike, Mules and Wound Dressing
Active Constituent/s: 60 g/L naphthalene, 25 g/L eucalyptus oil, 2.5 g/L chlorfenvinphos, 610 g/L petroleum oil, 25 g/L cresylic acid
Applicant Name: Fort Dodge Australia Pty Limited
Applicant ACN: 000 074 902
Summary of Use: Antiseptic and insecticidal dressing for treatment of blowfly strike on sheep, and for use at mulesing and marking. Helps protect wounds form blowfly strike. Suitable for use on superficial wounds on sheep, cattle and horses.
Date of Registration: 16 May 2005
Label Approval No: 58998/400g/0305

4.VARIATIONS

Product Name: Protech Duramune C3 Canine Distemper, Adenovirus & Parvovirus Live Vaccine
Applicant Name: Fort Dodge Australia Pty Limited
Summary of Use: The changes included the instruction leaflet to indicate that the vaccine are efficacious and protective in six week of age and older dogs for up to thirty-nine months following a second vaccination.
Date of Variation: 4 April 2005
Label Approval No: 51487/0205

Product Name: Genesis Ultra Pour-On Roundworm, Liver Fluke & External Parasiticide for Cattle
Applicant Name: Ancare Australia Pty Limited
Applicant ACN: 076 252 241
Summary of Use: Addition of a 15L pack size to be used as anthelminthic pour-on for cattle.
Date of Variation: 26 April 2005
Label Approval No: 56465/15L/0205

5.. RESTRICTED PRODUCT VARIATION

“No Entries”

Cheryl Venables
Pesticides Division
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604

Phone: (02) 6272 3894
Fax: (02) 6272 3218
Email: cheryl.venables@apvma.gov.au