Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the schedule hereto:
Schedule
Product: Combantrin-1 with Mebendazole Chocolate Squares
Active Ingredient(s): Mebendazole 100mg
Dosage Form: Medicated chocolate
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Mentholatum Australasia Pty Limited, Scoresby, Victoria, Australia
Product: Levobunolol Hydrochloride Eye Drops 0.5%
Active Ingredient(s): Levobunolol hydrochloride 0.5%w/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Alcon Couvreur SA, Puurs, Belgium
Product: Rebetol
Active Ingredient(s): Ribavirin 200mg
Dosage Form: Capsule
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Schering-Plough Products Inc, Las Piedras, Puerto Rico
Note: For use in combination only.
Product: Rebetron (Combination Product)
Active Ingredient(s): Interferon alfa-2b 15MIU/mL
Dosage Form: Solution for injection
Manufacturer(s): Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Schering-Plough Products Inc, Las Piedras, Puerto Rico
Active Ingredient(s): Ribavirin 200mg
Dosage Form: Capsule
Manufacturer(s): Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Schering-Plough Products Inc, Las Piedras, Puerto Rico
New Zealand Sponsor: Schering-Plough Pty Limited
Product: Rebetron (Combination Product)
Active Ingredient(s): Interferon alfa-2b 6MIU/mL
Dosage Form: Solution for injection
Manufacturer(s): Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Schering-Plough Products Inc, Las Piedras, Puerto Rico
Active Ingredient(s): Ribavirin 200mg
Dosage Form: Capsule
Manufacturer(s): Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Schering-Plough Products Inc, Las Piedras, Puerto Rico
New Zealand Sponsor: Schering-Plough Pty Limited
Product: Sinus & Nasal Decongestant
Active Ingredient(s): Pseudoephedrine hydrochloride 60mg
Dosage Form: Tablet
New Zealand Sponsor: PSM Healthcare Limited
Manufacturer(s): PSM Healthcare Limited, Wiri, Auckland
Dated this 7th day of April 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).