Notice Type
Departmental
Consent to the Distribution of a New Medicine Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto: Schedule Product: Cervitec. Active Ingredient(s): Thymol 1% w/w. Chlorhexidine acetate 1% w/w. Dosage Form: Topical solution. NZ Sponsor: Ivoclar Dental (NZ) Limited. Manufacturer(s): Vivadent Ets., Schaan, Liechtenstein. Product: Clear Eyes ACR. Active Ingredient(s): Naphazoline hydrochloride 0.012% w/v. Zinc sulphate 0.25% w/v. Glycerol 0.26% w/v. Dosage Form: Eye drops, solution. NZ Sponsor: Abbott Laboratories (NZ) Limited. Manufacturer(s): Abbott Laboratories, North Chicago, Illinois, United States of America. Product: Full Marks. Active Ingredient: Phenothrin 0.5% w/w. Dosage Form: Aerosol foam. NZ Sponsor: Pharmaco (NZ) Limited. Manufacturer(s): CCL Industries Limited, Runcorn, United Kingdom. Product: Genteal. Active Ingredient: Hypromellose 3 mg/g equivalent to 3.018 mg/mL. Dosage Form: Eye drops, solution. NZ Sponsor: Ciba Vision New Zealand. Manufacturer(s): Ciba Vision Canada Inc - Sterile Manufacturing, Mississauga, Ontario, Canada. Product: MDS QuickCard hCG One-Step Pregnancy Test. Active Ingredient(s): Bovine serum albumin 0.7 g. Goat anti-mouse polyclonal antibody 3.5 g. Goat Anti-alpha-hCG Polyclonal Antibody 1.4 g. Murine Anti-beta-hCG Monoclonal Antibody-Colloidal Gold Conjugate 1.4 g. Dosage Form: Pregnancy test kit. NZ Sponsor: Medical & Dental Supplies (NZ) Limited. Manufacturer(s): Phamatech, Padgett Rd, San Diego, California, United States of America. Phamatech, Activity Rd, San Diego, California, United States of America. Product: MDS QuickStick hCG One-Step Pregnancy Test. Active Ingredient(s): Bovine serum albumin 0.7 g. Goat anti-mouse polyclonal antibody 3.5 g. Goat Anti-alpha-hCG Polyclonal Antibody 1.4 g. Murine Anti-beta-hCG Monoclonal Antibody-Colloidal Gold Conjugate 1.4 g. Dosage Form: Pregnancy test kit. NZ Sponsor: Medical & Dental Supplies (NZ) Limited. Manufacturer(s): Phamatech, Padgett Road, San Diego, California, United States of America. Phamatech, Activity Road, San Diego, California, United States of America. Product: PicoPrep. Active Ingredient: Sodium picosulphate 0.64 mg/g. Dosage Form: Powder. NZ Sponsor: New Zealand Surgical Limited. Manufacturer(s): DFC Thompson Australia Pty Limited, Thornleigh, N.S.W., Australia. Product: Robitussin DM-P Extra Strength. Active Ingredient(s): Dextromethorphan hydrobromide 3 mg/mL. Pseudoephedrine hydrochloride 6 mg/mL. Dosage Form: Syrup. NZ Sponsor: Whitehall Laboratories (NZ) Limited. Manufacturer(s): Interphil Laboratories Inc, Cabuyao, Laguna, Philippines. Wyeth Australia Pty Limited, Smithfield, N.S.W., Australia. Product: Synagis. Active Ingredient: Palivizumab 122 mg. Dosage Form: Powder for injection. NZ Sponsor: Abbott Laboratories (NZ) Limited. Manufacturer(s): Abbott SpA, Latina, Italy. Boehringer Ingelheim Pharma KG, Biberach an der Riss, Germany. Product: Synagis. Active Ingredient: Palivizumab 73 mg. Dosage Form: Powder for injection. NZ Sponsor: Abbott Laboratories (NZ) Limited. Manufacturer(s): Abbott SpA, Latina, Italy. Boehringer Ingelheim Pharma KG, Biberach an der Riss, Germany. Product: Tamoxifen Hexal. Active Ingredient: Tamoxifen citrate 15.2 mg equivalent to 10 mg tamoxifen. Dosage Form: Film coated tablet. NZ Sponsor: Hexal New Zealand Limited. Manufacturer(s): Salutas Pharma GmbH, Barleben, Germany. Product: Tamoxifen Hexal. Active Ingredient: Tamoxifen citrate 30.4 mg equivalent to 20 mg tamoxifen. Dosage Form: Film coated tablet. NZ Sponsor: Hexal New Zealand Limited. Manufacturer(s): Salutas Pharma GmbH, Barleben, Germany. Product: Visine Allergy with Antihistamine. Active Ingredient(s): Naphazoline hydrochloride 0.25 mg/mL. Pheniramine maleate 3 mg/mL. Dosage Form: Eye drops, solution. NZ Sponsor: Pfizer Laboratories Limited. Manufacturer(s): AstraZeneca (Australia) Limited, Melbourne, Victoria, Australia. Taylor Pharmacal Company, Decatur, Illinois, United States of America. Dated this 16th day of September 1999. S. S. JESSAMINE, Acting Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).
Publication Date
23 Sep 1999

Notice Number

1999-go6889

Page Number

3203

Issue Number

133