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 medicines set out in the Schedule hereto:
Schedule
Product: Fortovase
Active Ingredient(s): Saquinavir 200mg
Dosage Form: liquid filled Soft gelatin capsule
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): R P Scherer GmbH, Eberbach/Baden, Germany
Note: This consent is valid for 2 years from 4 February 2001.
Product: Ziagen
Active Ingredient(s): Abacavir sulphate 23.4mg/mL equivalent to 20mg/ml abacavir base.
Dosage Form: Oral solution
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturer(s): Glaxo Wellcome Operations, Speke, Liverpool, United Kingdom
Note: This consent is valid for 2 years from 25 February 2001.
Product: Ziagen
Active Ingredient(s): Abacavir sulphate 351mg equivalent to 300mg abacavir
Dosage Form: Film coated tablet
New Zealand Sponsor: Glaxo Wellcome New Zealand Limited
Manufacturer(s): Glaxo Wellcome Operations, Ware, Hertfordshire, United Kingdom
Note: This consent is valid for 2 years from 25 February 2001.
Dated this 8th day of November 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).