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: Viracept
Active Ingredient(s): Nelfinavir mesylate 58.5mg/g equivalent 50 mg/g nelfinavir free base
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): F Hoffmann-La Roche AG, Head Office and manufacturing site, Basel, Switzerland
Note: This product has provisional consent that is valid to 12 February 2002.
Product: Viracept
Active Ingredient(s): Nelfinavir mesylate 292.25mg equivalent 250 mg nelfinavir free base
Dosage Form: Tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): F Hoffmann-La Roche AG, Head Office and manufacturing site, Basel, Switzerland
Mova Pharmaceutical Corporation, Villa Blanca Industrial Park, Caguas, Puerto Rico
Productos Roche S.A., Poligono Ind. Leganes, Leganes (Madrid), Spain
Note: This product has provisional consent that is valid to 12 February 2002.
Dated this 25th day of July 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).