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: AOSept Plus
Active Ingredient: Hydrogen peroxide 3.5%w/v
Dosage Form: Contact lens solution
New Zealand Sponsor: Ciba Vision New Zealand
Manufacturer: Ciba Vision Canada Inc - Sterile Manufacturing, Mississauga, Ontario, Canada
Product: Apo-Ipravent Sterules
Active Ingredient) Ipratropium bromide (monohydrate) 500Ág/mL
Dosage Form: Solution for inhalation
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Novex Pharma Inc, Richmond Hill, Ontario, Canada
Product: Optrex Fresh Eyes Singles
Active Ingredient: Witch hazel (distilled) 13%v/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: Boots Healthcare New Zealand Limited
Manufacturer: Laboratoire Unither, Amiens Cedex 2, France
Product: Precedex
Active Ingredient: Dexmedetomidine 100Ág/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer(s): Abbott Laboratories Inc, Rocky Mount, North Carolina, United States of America
Orion Corporation Farmos, Espoo, Finland
Product: Recormon
Active Ingredient: Epoetin beta 1,000IU
Dosage Form: 0.3mL pre-filled syringe Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 10,000IU
Dosage Form: 0.6mL pre-filled syringe Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Sandhofer Strasse 116, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 2,000IU
Dosage Form: 0.3mL pre-filled syringe Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 3,000IU
Dosage Form: 0.3mL pre-filled syringe Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 4,000IU
Dosage Form: 0.3mL pre-filled syringe Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 5,000IU
Dosage Form: 0.3mL pre-filled syringe Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 500IU
Dosage Form: 0.3mL pre-filled syringe Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 6,000IU
Dosage Form: 0.3mL pre-filled syringe Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Strepsils Dry Cough Liquid
Active Ingredient: Dextromethorphan hydrobromide 1mg/mL
Dosage Form: Solution
New Zealand Sponsor: PSM Healthcare Limited
Manufacturer: PSM Healthcare Limited, Wiri, Auckland
Dated this 16th day of January 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).