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: BeneFIX
Active Ingredient(s): Coagulation Factor IX (Recombinant) [rFIX] 1,000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer(s): Abbott Laboratories, McPherson, Kansas, United States of America
Product: BeneFIX
Active Ingredient(s): Coagulation Factor IX (Recombinant) [rFIX] 250IU
Dosage Form: Powder for injection
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer(s): Abbott Laboratories, McPherson, Kansas, United States of America
Product: BeneFIX
Active Ingredient(s): Coagulation Factor IX (Recombinant) [rFIX] 500IU
Dosage Form: Powder for injection
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer(s): Abbott Laboratories, McPherson, Kansas, United States of America
Product: Cefazolin
Active Ingredient(s): Cephazolin sodium 1.048g equivalent to 1g cephazolin
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer(s): GC Hanford Manufacturing Company, Syracuse, New York, United States of America
Product: Cefazolin
Active Ingredient(s): Cephazolin sodium 524mg equivalent to 500mg cephazolin
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer(s): GC Hanford Manufacturing Company, Syracuse, New York, United States of America
Product: Co-Diovan
Active Ingredient(s): Hydrochlorothiazide 12.5mg
Valsartan 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Pharma AG, Stein, Switzerland
Product: ReNu MultiPlus Great Start Kit
Active Ingredient(s): Hydroxyalkyl phosphonate 1mg/mL
Poloxamine 10mg/mL
Polyhexamethylene Biguanide 0.00779mg/mL
Dosage Form: ReNu MultiPlus Multi-Purpose Contact lens solutionActive
Ingredient(s): Povidone 12.5mg/mL
Dosage Form: ReNu MultiPlus Lubricating & Rewetting Drops Contact lens solution
New Zealand Sponsor: Bausch and Lomb (NZ) Limited
Manufacturer(s): Bausch & Lomb Personal Products Division, Greenville, South Carolina, United States of America
Product: Trileptal
Active Ingredient(s): Oxcarbazepine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Pharma AG, Stein, Switzerland
Product: Trileptal
Active Ingredient(s): Oxcarbazepine 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland
Product: Trileptal
Active Ingredient(s): Oxcarbazepine 600mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland
Product: Vicks Formula 44 Expectorant & Cough Suppressant Syrup
Active Ingredient(s): Dextromethorphan hydrobromide 0.07%w/v
Guaiphenesin 1%w/v
Dextromethorphan hydrobromide 0.07%w/v
Dosage Form: Syrup
New Zealand Sponsor: Procter & Gamble NPD Inc
Manufacturer(s): PT Procter & Gamble Indonesia, Ujung Mentang, Jakarta, Indonesia
Product: Vicks Formula 44 for Dry Coughs
Active Ingredient(s): Dextromethorphan hydrobromide 0.133%w/v
Dosage Form: Syrup
New Zealand Sponsor: Procter & Gamble NPD Inc
Manufacturer(s): Procter & Gamble GmbH, Gross Gerau, Germany
Dated this 2nd 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).