Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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: Aerius
Active Ingredient(s): Desloratadine 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Schering-Plough SpA, Comazzo, Italy
Product: Atracurium Besylate Injection
Active Ingredient(s): Atracurium besylate 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer(s): David Bull Laboratories Limited, Mulgrave North, Victoria, Australia
Product: Claramax
Active Ingredient(s): Desloratadine 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Schering-Plough SpA, Comazzo, Italy
Product: Coldrex Day/Night (Combination Product)
Active Ingredient(s): Chlorpheniramine maleate 2mg/dose
Paracetamol 500mg/dose
Pseudoephedrine hydrochloride 30mg/dose
Dosage Form: Night formulation Film coated tablet
Manufacturer(s): SmithKline Beecham (Australia) Pty Limited, Consumer Healthcare, Ermington,
New South Wales, Australia
Active Ingredient(s): Paracetamol 500mg/dose
Pseudoephedrine hydrochloride 30mg/dose
Dosage Form: Day formulation Film coated tablet
Manufacturer(s): SmithKline Beecham (Australia) Pty Limited, Consumer Healthcare, Ermington, New South Wales, Australia
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Product: Infanrix-IPV
Active Ingredient(s): Adsorbed tetanus vaccine 80IU/mL
Detoxified pertussis toxin 50µg/mL
Diphtheria toxoid (adsorbed) 60IU/mL
Pertussis 69kDa outer membrane protein 16µg/mL
Pertussis filamentous haemagglutinin 50µg/mL
Polio virus type 1 80DAgU/mL
Polio virus type 2 16DAgU/mL
Polio virus type 3 64DAgU/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium
Product: Zantac Relief
Active Ingredient(s): Ranitidine (as hydrochloride) 168mg equivalent to 150mg ranitidine
Dosage Form: Film coated tablet
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturer(s): Glaxo Wellcome Australia Limited, Boronia, Victoria, Australia
Glaxo Wellcome Operations, Ware, Hertfordshire, United Kingdom
Product: Zyprexa IM
Active Ingredient(s): Olanzapine 10mg
Dosage Form: Powder for injection
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer(s): Eli Lilly & Co, Lilly Technology Centre, Indianapolis, Indiana, United States of America

Dated this 26th day of April 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).