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: Advate
Active Ingredient: Octocog alfa 1,000IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter AG, Vienna, Austria
Baxter Bioscience AG, Neuchatel, Switzerland
Product: Advate
Active Ingredient: Octocog alfa 1,500IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter AG, Vienna, Austria
Baxter Bioscience AG, Neuchatel, Switzerland
Product: Advate
Active Ingredient: Octocog alfa 250IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter AG, Vienna, Austria
Baxter Bioscience AG, Neuchatel, Switzerland
Product: Advate
Active Ingredients: Octocog alfa 500IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter AG, Vienna, Austria
Baxter Bioscience AG, Neuchatel, Switzerland
Product: Perfalgan 1g/100mL
Active Ingredient: Paracetamol 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturers: Bristol-Myers Squibb S.r.l., Anagni, Italy
Laboratoire Renaudin, Itxassou, France
Product: Perfalgan 500mg/50mL
Active Ingredient: Paracetamol 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturers: Bristol-Myers Squibb S.r.l., Anagni, Italy
Laboratoire Renaudin, Itxassou, France
Product: Tracleer
Active Ingredient: Bosentan 125mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics
Manufacturer: Patheon Inc, Mississauga, Ontario, Canada
Product: Tracleer
Active Ingredient: Bosentan 62.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics
Manufacturer: Patheon Inc, Mississauga, Ontario, Canada
Dated this 19th day of January 2007.
BARRY BORMAN, Acting-Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).