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 medicine set out in the Schedule hereto: Schedule Product: Betaferon. Active Ingredient(s): Interferon beta-1b 0.3 mg. Dosage Form: Powder for injection. NZ Sponsor: Schering (NZ) Limited. Manufacturer(s): Chiron Corporation, Emeryville, California, United States of America. Product: Colgate Neutrafluor Fluoride Tablet. Active Ingredient(s): Sodium fluoride 0.5525 mg equivalent to 0.25 mg fluoride. Dosage Form: Chewable/dispersible tablet. NZ Sponsor: Colgate-Palmolive Limited. Manufacturer(s): KV Pharmaceutical Co, St Louis, Missouri, United States of America. Product: Focus Care All-in-One. Active Ingredient(s): Polyhexanide 0.001 mg/mL. Dosage Form: Contact lens solution. NZ Sponsor: Ciba Vision New Zealand. Manufacturer(s): [ix]Ciba Vision Canada Inc - Sterile Manufacturing, Mississauga, Ontario, Canada. Laboratoires Ciba Vision Faure, La Lombardiere Industrial Zone, Annonay Cedex, France. Product: Focus Care One Step. Active Ingredient(s): Hydrogen peroxide 30 mg/mL. Dosage Form: Contact lens solution. NZ Sponsor: Ciba Vision New Zealand. Manufacturer(s): Ciba Vision Canada Inc - Sterile Manufacturing, Mississauga, Ontario, Canada. Product: Monazole 7. Active Ingredient(s): Miconazole nitrate 20 mg/g. Dosage Form: Vaginal cream. NZ Sponsor: Technilab Inc. Manufacturer(s): Technilab Inc, Mirabel, Quebec, Canada. Product: Poly Visc. Active Ingredient(s): [ix]Liquid paraffin 30 mg/g. Wool fat 30 mg/g. Dosage Form: Eye ointment. NZ Sponsor: Pacific Pharmaceuticals Limited. Manufacturer(s): [ix]Alcon Couvreur SA, Puurs, Belgium. Alcon Laboratories Inc, Fort Worth, Texas, United States of America. Product: Robitussin DX Extra Strength Cough Control. Active Ingredient(s): Dextromethorphan hydrobromide 3 mg/mL. Dosage Form: Syrup. NZ Sponsor: Whitehall Laboratories (NZ) Limited. Manufacturer(s): [ix]Interphil Laboratories Inc, Canlubang Industrial Estate, BO., Pittland, Cabuyao, Laguna, Philippines. Wyeth Australia Pty Limited, Smithfield,, New South Wales, Australia. Product: Telfast. Active Ingredient(s): Fexofenadine hydrochloride 30 mg. Dosage Form: Film coated tablet. NZ Sponsor: Hoechst Marion Roussel (NZ) Limited. Manufacturer(s): Hoechst Marion Roussel Inc, Kansas City, Missouri, United States of America. Product: Telfast. Active Ingredient(s): Fexofenadine hydrochloride 60 mg. Dosage Form: Film coated tablet. NZ Sponsor: Hoechst Marion Roussel (NZ) Limited. Manufacturer(s): Hoechst Marion Roussel Inc, Kansas City, Missouri, United States of America. Dated this 7th day of October 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
14 Oct 1999

Notice Number

1999-go7517

Page Number

3583