Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicines which were referred to the Minister of Health under the provisions of section 24 (5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Lescol XL
Active Ingredient: Fluvastatin sodium 84.24mg equivalent to 80mg fluvastatin
Dosage Form: Modified release tablet
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturers: Novartis Farmaceutica SA, Barbera del Valles, Barcelona, Spain
Novartis Pharma Stein AG, Stein, Switzerland
Product: MeNZB
Active Ingredient: Neisseria meningitidis group B (strain NZ98/254) 25µg/dose
Dosage Form: Suspension for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Chiron S.r.l, Bellaria, Rosia, Sovicille, Italy
Product: Stromectol
Active Ingredient: Ivermectin 3mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck Sharp & Dohme BV, Haarlem, The Netherlands
Product: Trileptal
Active Ingredient: Oxcarbazepine 60mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Novartis Pharma SAS, Huningue, France
Product: Trileptal
Active Ingredient: Oxcarbazepine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturers: Novartis Farma SpA, Pharma Production Plant, Torre Annunziata, Italy
Novartis Pharma Stein AG, Stein, Switzerland
Product: Trileptal
Active Ingredient: Oxcarbazepine 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturers: Novartis Farma SpA, Pharma Production Plant, Torre Annunziata, Italy
Novartis Pharma Stein AG, Stein, Switzerland
Product: Trileptal
Active Ingredient: Oxcarbazepine 600mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturers: Novartis Farma SpA, Pharma Production Plant, Torre Annunziata, Italy
Novartis Pharma Stein AG, Stein, Switzerland
Dated this 5th day of January 2006.
CYNTHIA MALING, Acting-Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).