Notice Type
Departmental
Consent to the Distribution of Changed Medicines Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicines which were referred to the Minister of Health under the provisions of section 24 (5) of the Act and are set out in the Schedule hereto: Schedule Product: Cerezyme. Active Ingredient(s): Imiglucerase-rch 212U. Dosage Form: Powder for injection. NZ Sponsor: Medra Services. Manufacturer(s): Genzyme Corporation, Allston, Massachusetts, United States of America. Product: Havrix 1440 vaccine. Active Ingredient(s): Hepatitis A vaccine 1,440 EU/ mL. Dosage Form: Suspension for injection. NZ Sponsor: SmithKline Beecham (NZ) Limited. Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium. Product: Havrix Junior. Active Ingredient(s): Hepatitis A vaccine 1,440 EU/mL equivalent to 720 EU/0.5 mL. Dosage Form: Suspension for injection. NZ Sponsor: SmithKline Beecham (NZ) Limited. Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium. Product: Lipitor. Active Ingredient(s): Atorvastatin calcium 10 mg. Dosage Form: Film coated tablet. NZ Sponsor: Parke Davis (Div. Warner Lambert NZ Limited). Manufacturer(s): Godecke AG, Freiburg, Germany. Parke Davis Pharmaceuticals Limited, Vega Baja, Puerto Rico. Parke-Davis, Usine Pharmaceutique d'Angers, Angers Cedex 01, France. Warner Lambert Company, Lititz, Pennsylvania, United States of America. Product: Lipitor. Active Ingredient(s): Atorvastatin calcium 20 mg. Dosage Form: Film coated tablet. NZ Sponsor: Parke Davis (Div. Warner Lambert NZ Limited). Manufacturer(s): Godecke AG, Freiburg, Germany. Parke Davis Pharmaceuticals Limited, Vega Baja, Puerto Rico. Parke-Davis, Usine Pharmaceutique d'Angers, Angers Cedex 01, France. Warner Lambert Company, Lititz, Pennsylvania, United States of America. Product: Lipitor. Active Ingredient(s): Atorvastatin calcium 40 mg. Dosage Form: Film coated tablet. NZ Sponsor: Parke Davis (Div. Warner Lambert NZ Limited). Manufacturer(s): Godecke AG, Freiburg, Germany. Parke Davis Pharmaceuticals Limited, Vega Baja, Puerto Rico. Parke-Davis, Usine Pharmaceutique d'Angers, Angers Cedex 01, France. Warner Lambert Company, Lititz, Pennsylvania, United States of America. Product: Lumavir. Active Ingredient(s): Penciclovir sodium 13.63 mg/mL. Dosage Form: Powder for infusion. NZ Sponsor: SmithKline Beecham (NZ) Limited. Manufacturer(s): SmithKline Beecham Pharmaceuticals, Conshohocken, Pennsylvania, United States of America. Product: Lumavir. Active Ingredient(s): Penciclovir sodium 27.27 mg/mL. Dosage Form: Powder for infusion. NZ Sponsor: SmithKline Beecham (NZ) Limited. Manufacturer(s): SmithKline Beecham Pharmaceuticals, Conshohocken, Pennsylvania, United States of America. Product: Prozac 20. Active Ingredient(s): Fluoxetine hydrochloride 22.36 mg equivalent to 20 mg fluoxetine base. Dosage Form: Capsule. NZ Sponsor: Eli Lilly and Company (NZ) Limited. Manufacturer(s): Eli Lilly & Co (UK) Limited, Basingstoke, Hampshire, England. Eli Lilly & Co, Lilly Technology Centre, Indianapolis, Indiana, United States of America. Product: Prozac 20. Active Ingredient(s): Fluoxetine hydrochloride 22.36 mg equivalent to 20 mg fluoxetine base. Dosage Form: Dispersible tablet. NZ Sponsor: Eli Lilly and Company (NZ) Limited. Manufacturer(s): Eli Lilly & Co (UK) Limited, Basingstoke, Hampshire, England. Eli Lilly & Co, Lilly Technology Centre, Indianapolis, Indiana, United States of America. Lilly SA, Poligono Industrial, Alcobendas, Madrid, Spain. Dated this 20th 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
28 Oct 1999

Notice Number

1999-go7902

Page Number

3838