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: Aggrastat. Active Ingredient(s): Tirofiban hydrochloride (monohydrate) 0.05618 mg/mL. Dosage Form: Solution for infusion. NZ Sponsor: Merck Sharp & Dohme (New Zealand) Limited. Manufacturer(s): Baxter Healthcare Corporation, Marion, North Carolina, United States of America. Product: Aggrastat. Active Ingredient(s): Tirofiban hydrochloride (monohydrate) 0.281 mg/mL. Dosage Form: Concentrate for infusion. NZ Sponsor: Merck Sharp & Dohme (New Zealand) Limited. Manufacturer(s): Ben Venue Laboratories Inc, Bedford, Ohio, United States of America. Product: Klacid Hp7 (Combination Product). Active Ingredient(s): Omeprazole 20 mg. Dosage Form: Capsule. Manufacturer(s): Astra Pharmaceutical Production AB, Strangnasvagen 44, Sodertalje, Sweden; and Astra Pharmaceuticals Limited, Headway, Great Oakley, Corby, Northamptonshire, United Kingdom. Active Ingredient(s): Amoxycillin (trihydrate) 573.96 mg. Dosage Form: Capsule. Manufacturer(s): Apo-Biotics Inc., Weston, Ontario, Canada. Active Ingredient(s): Clarithromycin 500 mg. Dosage Form: Film coated tablet. Manufacturer(s): Abbott Laboratories (UK) Limited, Queensborough, Kent, England; Abbott SpA, Campoverde di Aprilia, Latina, Italy; and Abbott Australasia Pty Limited, Kurnell, New South Wales, Australia. NZ Sponsor: Abbott Laboratories (NZ) Limited. Product: Losec Hp7 OAC (Combination Product). Active Ingredient(s): Omeprazole 20 mg. Dosage Form: Capsule. Manufacturer(s): Astra Pharmaceutical Production AB, Strangnasvagen 44, Sodertalje, Sweden; and Astra Pharmaceuticals Limited, Headway, Great Oakley, Corby, Northamptonshire, United Kingdom. Active Ingredient(s): Amoxycillin (trihydrate) 573.96 mg. Dosage Form: Capsule. Manufacturer(s): Apo-Biotics Inc, Weston, Ontario, Canada. Active Ingredient(s): Clarithromycin 500 mg. Dosage Form: Film coated tablet. Manufacturer(s): Abbott Laboratories (UK) Limited, Queensborough, Kent, England; Abbott SpA, Campoverde di Aprilia, Latina, Italy; and Abbott Australasia Pty Limited, Kurnell, New South Wales, Australia. NZ Sponsor: AstraZeneca Limited. Product: Tazko. Active Ingredient(s): Felodipine 5 mg.[ql] Ramipril 5 mg. Dosage Form: Film coated tablet. NZ Sponsor: Hoechst Marion Roussel (NZ) Limited. Manufacturer(s): Astra Pharmaceutical Production AB, Sodertalje, Sweden. Product: Tazko. Active Ingredient(s): Felodipine 2.5 mg.[ql] Ramipril 2.5 mg. Dosage Form: Film coated tablet. NZ Sponsor: Hoechst Marion Roussel (NZ) Limited. Manufacturer(s): Astra Pharmaceutical Production AB, Sodertalje, Sweden. Product: Typherix. Active Ingredient(s): Vi capsular polysaccharide of S. typhi ty2 25g. Dosage Form: Suspension for injection. NZ Sponsor: SmithKline Beecham (NZ) Limited. Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium. Product: Visipaque. Active Ingredient(s): Iodixanol 305 mg/mL Weight refers to anhydrous active. Dosage Form: Solution for injection. NZ Sponsor: Nycomed New Zealand Limited. Manufacturer(s): Nycomed Ireland Limited, IDA Industrial Estate, Carrigtohil, Co. Cork, Eire; and Nycomed AS Production, Oslo, Norway. Product: Ziaxel 120/0.5. Active Ingredient(s): Trandolapril 0.5 mg.[ql] Verapamil hydrochloride 120 mg. Dosage Form: Combination capsule. NZ Sponsor: Hoechst Marion Roussel (NZ) Limited. Manufacturer(s): Knoll AG, Ludwigshafen/Rhein, Germany. Product: Ziaxel 180/1. Active Ingredient(s): Trandolapril 1 mg.[ql] Verapamil hydrochloride 180 mg. Dosage Form: Combination capsule. NZ Sponsor: Hoechst Marion Roussel (NZ) Limited. Manufacturer(s): Knoll AG, Ludwigshafen/Rhein, Germany. Product: Ziaxel 180/2. Active Ingredient(s): Trandolapril 2 mg.[ql] Verapamil hydrochloride 180 mg. Dosage Form: Combination capsule. NZ Sponsor: Hoechst Marion Roussel (NZ) Limited. Manufacturer(s): Knoll AG, Ludwigshafen/Rhein, Germany. Dated this 22nd day of July 1999. G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).
Publication Date
29 Jul 1999

Notice Number

1999-go5396

Page Number

2077