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: Stalevo
Active Ingredients: Carbidopa monohydrate 27mg equivalent to carbidopa 25mg
Entacapone 200mg
Levodopa 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Orion Pharma, Espoo, Finland
Product: Stalevo
Active Ingredients: Carbidopa monohydrate 40.5mg equivalent to carbidopa 37.5mg
Entacapone 200mg
Levodopa 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Orion Pharma, Espoo, Finland
Product: Stalevo
Active Ingredients: Carbidopa monohydrate 13.5mg equivalent to carbidopa 12.5mg
Entacapone 200mg
Levodopa 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Orion Pharma, Espoo, Finland
Product: Topistin
Active Ingredient: Ciprofloxacin lactate 2.544mg/mL equivalent to Ciprofloxacin 2.00 mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Elpen SA, Pikermi Attica, Greece
Dated this 12th day of August 2004.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).