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: Abilify
Active Ingredient: Aripiprazole 10mg
Dosage Form: Tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturers: Bristol-Myers Squibb Manufacturing Company, Mayaguez, Puerto Rico
Otsuka Pharmaceutical Co Limited, Matsutani, Itano-cho, Itano-gun, Tokushima, Japan
Product: Abilify
Active Ingredient: Aripiprazole 15mg
Dosage Form: Tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturers: Bristol-Myers Squibb Manufacturing Company, Mayaguez, Puerto Rico
Otsuka Pharmaceutical Co Limited, Matsutani, Itano-cho, Itano-gun, Tokushima, Japan
Product: Abilify
Active Ingredient: Aripiprazole 2mg
Dosage Form: Tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturers: Bristol-Myers Squibb Manufacturing Company, Mayaguez, Puerto Rico
Otsuka Pharmaceutical Co Limited, Matsutani, Itano-cho, Itano-gun, Tokushima, Japan
Product: Abilify
Active Ingredient: Aripiprazole 20mg
Dosage Form: Tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturers: Bristol-Myers Squibb Manufacturing Company, Mayaguez, Puerto Rico
Otsuka Pharmaceutical Co Limited, Matsutani, Itano-cho, Itano-gun, Tokushima, Japan
Product: Abilify
Active Ingredient: Aripiprazole 30mg
Dosage Form: Tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturers: Bristol-Myers Squibb Manufacturing Company, Mayaguez, Puerto Rico
Otsuka Pharmaceutical Co Limited, Matsutani, Itano-cho, Itano-gun, Tokushima, Japan
Product: Abilify
Active Ingredient: Aripiprazole 5mg
Dosage Form: Tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturers: Bristol-Myers Squibb Manufacturing Company, Mayaguez, Puerto Rico
Otsuka Pharmaceutical Co Limited, Matsutani, Itano-cho, Itano-gun, Tokushima, Japan
Product: Apidra 100IU/mL
Active Ingredient: Insulin glulisine 3.49mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany
Product: Aspen Ciprofloxacin
Active Ingredient: Ciprofloxacin 2mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: ACS Dobfar Info SA, Campascio, Switzerland
Product: Cefuroxime Injection
Active Ingredient: Cefuroxime sodium 1,577.8mg equivalent to cefuroxime 1,500mg
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Sandoz GmbH, Kundl, Austria
Product: Cefuroxime Injection
Active Ingredient: Cefuroxime sodium 263mg equivalent to cefuroxime 250mg
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer Sandoz GmbH, Kundl, Austria
Product: Cefuroxime Injection
Active Ingredient: Cefuroxime sodium 788.9mg equivalent to cefuroxime 750mg
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Sandoz GmbH, Kundl, Austria
Product: SimStatin
Active Ingredient: Simvastatin 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturers: Rottendorf Pharma GmbH, Ennigerloh, Germany
Synthon Hispania SL, Poligno Las Salinas, Sant Boi de Llobregat, Barcelona, Spain
Product: Symbicort Rapihaler
Active Ingredients: Budesonide 80µg/dose
Formoterol fumarate 4.5µg/dose
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca Dunkerque Production, Cedex, France
Product: Symbicort Rapihaler
Active Ingredients: Budesonide 160µg/dose
Formoterol fumarate 4.5µg/dose
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca Dunkerque Production, Dunkerque Cedex, France
Dated this 26th day of January 2007.
MARK JACOBS, Acting Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).