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: Apo-Naproxen SR
Active Ingredient(s): Naproxen 750mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Apotex Inc, Weston, Ontario, Canada
Product: Diovan
Active Ingredient(s): Valsartan 160mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland
Product: Diovan
Active Ingredient(s): Valsartan 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland
Product: Diovan
Active Ingredient(s): Valsartan 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland
Product: Lora-tabs
Active Ingredient(s): Loratadine 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Laboratorios Vita S.A., Sant Joan Depsi, Barcelona, Spain
Product: Ospamox Paediatric Drops
Active Ingredient(s): Amoxycillin (trihydrate) 114.8mg/mL equivalent to 100mg/mL amoxycillin
Dosage Form: Granules for oral suspension
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Symbicort 100/6 Turbuhaler
Active Ingredient(s): Budesonide 80µg/dose equivalent to 100µg metered dose
Eformoterol fumarate 4.5µg/dose equivalent to 6µg metered dose
Dosage Form: Powder for inhalation
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): AstraZeneca AB, Sodertalje, Sweden
Product: Symbicort 200/6 Turbuhaler
Active Ingredient(s): Budesonide 160µg/dose equivalent to 200µg metered dose
Eformoterol fumarate 4.5µg/dose equivalent to 6µg metered dose
Dosage Form: Powder for inhalation
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): AstraZeneca AB, Sodertalje, Sweden
Dated this 25th day of July 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).