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: Gonal-F. Active Ingredient(s): Follitropin alpha 150 IU. Dosage Form: Powder for injection. NZ Sponsor: Douglas Pharmaceuticals Limited. Manufacturer(s): Laboratoires Serono SA (Switzerland), Zone Industrial de l'Ouriettaz, Aubonne, Switzerland. Serono Pharma SpA, Zone Industriale di Modugno, Bari, Italy. Product: Gonal-F. Active Ingredient(s): Follitropin alpha 75 IU. Dosage Form: Powder for injection. NZ Sponsor: Douglas Pharmaceuticals Limited. Manufacturer(s): Laboratoires Serono SA., Zone Industrial de l'Ouriettaz, Aubonne, Switzerland. Serono Pharma SpA, Zone Industriale di Modugno, Bari, Italy. Product: Humalog. Active Ingredient(s): Insulin lispro 100 U/mL. Dosage Form: Solution for injection (vial). NZ Sponsor: Eli Lilly and Company (NZ) Limited. Manufacturer(s): Lilly France SA, Fegersheim, France. Product: Humalog. Active Ingredient(s): Insulin lispro 100 U/mL. Dosage Form: Solution for injection (cartridge). NZ Sponsor: Eli Lilly and Company (NZ) Limited. Manufacturer(s): Lilly France SA, Fegersheim, France. Product: Mabthera. Active Ingredient(s): Rituximab 10 mg/mL. Dosage Form: Concentrate for infusion. NZ Sponsor: Roche Products (New Zealand) Limited. Manufacturer(s): Genentech Inc, South San Francisco, California, United States of America. IDEC Pharmaceuticals Corp., San Diego, California, United States of America. Product: NovoSeven. Active Ingredient(s): Factor VIIa (recombinant human) 1.2 mg. Dosage Form: Powder for injection. NZ Sponsor: Novo Nordisk Pharmaceuticals Limited. Manufacturer(s): Novo Nordisk A/S, Gentofte, Denmark. Product: NovoSeven. Active Ingredient(s): Factor VIIa (recombinant human) 2.4 mg. Dosage Form: Powder for injection. NZ Sponsor: Novo Nordisk Pharmaceuticals Limited. Manufacturer(s): Novo Nordisk A/S, Gentofte, Denmark. Product: NovoSeven. Active Ingredient(s): Factor VIIa (recombinant human) 4.8 mg. Dosage Form: Powder for injection. NZ Sponsor: Novo Nordisk Pharmaceuticals Limited. Manufacturer(s): Novo Nordisk A/S, Gentofte, Denmark. Product: Qvar 100 Autohaler. Active Ingredient(s): Beclomethasone dipropionate 100 g/dose. Dosage Form: Aerosol inhaler, metered dose. NZ Sponsor: 3M New Zealand Limited. Manufacturer(s): 3M Health Care (UK) Limited, Loughborough, Leicestershire, England. Product: Qvar 100 Inhaler. Active Ingredient(s): Beclomethasone dipropionate 100 g/dose. Dosage Form: Aerosol inhaler, metered dose. NZ Sponsor: 3M New Zealand Limited. Manufacturer(s): 3M Health Care (UK) Limited, Loughborough, Leicestershire, England. Product: Qvar 50 Autohaler. Active Ingredient(s): Beclomethasone dipropionate 50 g/dose. Dosage Form: Aerosol inhaler, metered dose. NZ Sponsor: 3M New Zealand Limited. Manufacturer(s): 3M Health Care (UK) Limited, Loughborough, Leicestershire, England. Product: Qvar 50 Inhaler. Active Ingredient(s): Beclomethasone dipropionate 50 g/dose. Dosage Form: Aerosol inhaler, metered dose. NZ Sponsor: 3M New Zealand Limited. Manufacturer(s): 3M Health Care (UK) Limited, Loughborough, Leicestershire, England. Product: Taxol. Active Ingredient(s): Paclitaxel 6 mg/mL. Dosage Form: Concentrate for infusion. NZ Sponsor: Bristol-Myers Squibb (N.Z.) Limited Pharmaceutical Group. Manufacturer(s): Bristol-Caribbean Inc, Foreign Trade Zone 7, Mayaguez, Puerto Rico. Dated this 20th 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-go8644

Page Number

4231