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: Optilast
Active Ingredient(s): Azelastine hydrochloride 0.05%w/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: 3M New Zealand Limited
Manufacturer(s): Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Rebif
Active Ingredient(s): Interferon beta 1a (recombinant chinese hamster) 22µg equivalent to 6 MIU
Dosage Form: Solution for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Rebif
Active Ingredient(s): Interferon beta 1a (recombinant chinese hamster) 44µg equivalent to 12 MIU
Dosage Form: Solution for injection
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Terbafin
Active Ingredient(s): Terbinafine hydrochloride 281.3 equivalent to 250mg terbinafine
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Genpharm Inc., Etobicoke, Ontario, Canada
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).