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: Diprivan 2% w/v
Active Ingredient(s): Propofol 20mg/mL
Dosage Form: Emulsion for injection (prefilled syringe)
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): Zeneca SpA, Caponago, Milan, Italy
Product: Diprivan 1% w/v
Active Ingredient(s): Propofol 10mg/mL
Dosage Form: Emulsion for injection (vial)
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): Pharmacia & Upjohn AB, Uppsala, Sweden
Zeneca SpA, Caponago, Milan, Italy
Product: Diprivan 1% w/v
Active Ingredient(s): Propofol 10mg/mL
Dosage Form: Solution for injection (prefilled syringe)
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): Zeneca SpA, Caponago, Milan, Italy
Product: Diprivan 1% w/v
Active Ingredient(s): Propofol 10mg/mL
Dosage Form: Emulsion for injection (ampoule)
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): Pharmacia & Upjohn AB, Uppsala, Sweden
Zeneca SpA, Caponago, Milan, Italy
Product: Intron-A
Active Ingredient(s): Interferon alfa-2b 5MIU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Schering-Plough Inc, Union, New Jersey, United States of America
Product: Prograf
Active Ingredient(s): Tacrolimus 1mg
Dosage Form: Capsule
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Fujisawa Ireland Limited, Killorglin, Co Kerry, Eire
Product: Prograf
Active Ingredient(s): Tacrolimus 5mg
Dosage Form: Capsule
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Fujisawa Ireland Limited, Killorglin, Co Kerry, Eire
Product: Prograf
Active Ingredient(s): Tacrolimus 5mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Fujisawa Ireland Limited, Killorglin, Co Kerry, Eire
Product: Taxotere
Active Ingredient(s): Docetaxel (trihydrate) 40mg/mL
Dosage Form: Solution for Concentrate for infusion
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer(s): Rhone-Poulenc Rorer Limited, Dagenham, Essex, United Kingdom
Rhone-Poulenc Rorer SA, Vitry sur Seine, France
Note: This product has provisional consent.
Dated this 24th day of August 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).