Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the schedule hereto:
Schedule
Product: Dry Cough Mixture
Active Ingredient: Dextromethorphan hydrobromide 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: PSM Healthcare Limited
Manufacturer: PSM Healthcare Limited, Wiri, Auckland
Product: Propofol 1% Fresenius
Active Ingredient: Propofol 10mg/mL
Dosage Form: Emulsion for infusion
New Zealand Sponsor: REM Systems Limited
Manufacturers: Fresenius Kabi Austria GmbH, Graz, Austria
Fresenius Kabi Deutschland GmbH, Bad Homburg v d Hohe, Germany
Product: Valcyte
Active Ingredients: Valganciclovir hydrochloride 496.3mg equivalent to 450mg valganciclovir
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Patheon Inc, Mississauga, Ontario, Canada
Product: Voluven
Active Ingredients: Hetastarch 6%
Sodium chloride 0.9%
Dosage Form: Solution for infusion
New Zealand Sponsor: REM Systems Limited
Manufacturer: Fresenius Kabi Deutschland GmbH, Friedberg, Germany
Dated this 24th day of April 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).