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: Actifed Chesty. Active Ingredient(s): Guaiphenesin 20 mg/mL. Pseudoephedrine hydrochloride 6 mg/mL. Dosage Form: Syrup. NZ Sponsor: Warner Lambert Consumer Healthcare Pty Limited. Manufacturer(s): Parke Davis Pty Limited, Caringbah, Sydney, Australia. Product: Actifed Dry. Active Ingredient(s): Dextromethorphan hydrobromide 2 mg/mL. Pseudoephedrine hydrochloride 6 mg/mL. Dosage Form: Syrup. NZ Sponsor: Warner Lambert Consumer Healthcare Pty Limited. Manufacturer(s): Parke Davis Pty Limited, Caringbah, Sydney, Australia. Product: Imodium Advanced. Active Ingredient(s): Loperamide hydrochloride 2 mg. Simethicone 125 mg. Dosage Form: Chewable tablet. NZ Sponsor: Janssen-Cilag Pty Limited. Manufacturer(s): Johnson & Johnson / Merck Consumer Pharmaceutical Company, Lancaster, Pennsylvania, United States of America. Product: Johnson's Baby Anti-Rash Powder. Active Ingredient(s): Zinc oxide 100 mg/g. Dosage Form: Topical powder. NZ Sponsor: Johnson & Johnson Pacific Pty Limited. Manufacturer(s): DFC Thompson Australia Pty Limited, Thornleigh, New South Wales, Australia. Product: Synvisc. Active Ingredient(s): Hylan polymer 8 mg/mL. Dosage Form: Solution for injection. NZ Sponsor: Bayer New Zealand Limited Health Care Division. Manufacturer(s): Biomatrix Medical Canada Inc, Pointe-Claire, Quebec, Canada. Product: Teslascan. Active Ingredient(s): Mangafodipir trisodium 0.01 mmol/mL. Dosage Form: Solution for injection. NZ Sponsor: Nycomed New Zealand Limited. Manufacturer(s): Abbott Laboratories, McPherson, Kansas, United States of America. Nycomed AS Production, Oslo, Norway. Product: WinRho SDF. Active Ingredient(s): Anti-D (Rho) immunoglobulin 600 IU equivalent to 120 g. Dosage Form: Powder for injection. NZ Sponsor: CSL (New Zealand) Limited. Manufacturer(s): Cangene Corporation, Winnipeg, Manitoba, Canada. Dated this 22nd day of November 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
25 Nov 1999

Notice Number

1999-go8645

Page Number

4232