Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the schedule hereto:
Schedule
Product: Viracept
Active Ingredient(s): Nelfinavir mesylate 58.5mg/g equivalent to 50mg/g nelfinavir free base
Dosage Form: Powder for oral solution
NZ Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): Oread Pharmaceutical Manufacturing, Palo Alto, California, United States of America
Note: This consent is valid for 2 years from 12 February 2000.
Product: Viracept
Active Ingredient(s): Nelfinavir mesylate 292.25mg equivalent to 250mg/g nelfinavir free base
Dosage Form: Tablet
NZ Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): F Hoffmann-La Roche AG, Head Office and manufacturing site, Basle, Switzerland
Mova Pharmaceutical Corporation, Villa Blanca Industrial Park, Caguas, Puerto Rico
Note: This consent is valid for 2 years from 12 February 2000.
Dated this 12th day of January 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).