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: Elevit
Active Ingredient(s): Biotin 0.20mg
Calcium ascorbate (dihydrate) 133mg equivalent to 100mg ascorbic acid
Calcium hydrogen phosphate (anhydrous) 378.89mg equivalent to 125mg Calcium
Calcium pantothenate 10mg
Cholecalciferol 6mg equivalent to 0.0125mg Vitamin D3
Copper sulphate (anhydrous) 2.51mg equivalent to 1mg copper
Cyanocobalamin 0.004mg
Dibasic Magnesium phosphate (trihydrate) 217.95mg
Ferrous fumarate 183mg equivalent to 60mg iron
Folic acid 0.8mg
Light magnesium oxide 114.2mg
Manganese sulphate (monohydrate) 3.08mg equivalent to 1mg manganese
Nicotinamide 19.mg
Pyridoxine hydrochloride 2.6mg
Retinol palmitate 9.6mg equivalent to 1200µg vitamin A
Riboflavin 1.8 mg
Thiamine nitrate 1.71mg equivalent to 1.6mg thiamine hydrochloride
Zinc sulphate (monohydrate) 20.6mg equivalent to 7.5mg zinc
dl-alpha tocopheryl acetate 15mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): Roche Products Limited, T/A Roche Consumer Health, Welwyn Garden City, Hertfordshire, United Kingdom
Product: Exelon
Active Ingredient(s): Rivastigmine hydrogen tartrate 0.8mg equivalent to 0.5mg rivastigmine
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Pharma AG., Basel, Switzerland
Product: Exelon
Active Ingredient(s): Rivastigmine hydrogen tartrate 1.6mg equivalent to 1mg rivastigmine
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland
Product: Exelon
Active Ingredient(s): Rivastigmine hydrogen tartrate 2.4mg equivalent 1.5mg rivastigmine
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Farmaceutica SA, Barbera del Valles, Barcelona, Spain
Novartis Pharma Stein AG/SA, Stein, Switzerland
Product: Exelon
Active Ingredient(s): Rivastigmine hydrogen tartrate 4.8mg equivalent 3mg rivastigmine
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Farmaceutica SA, Barbera del Valles, Barcelona, Spain
Novartis Pharma Stein AG/SA, Stein, Switzerland
Product: Exelon
Active Ingredient(s): Rivastigmine hydrogen tartrate 7.2mg equivalent to 4.5mg rivastigmine
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Farmaceutica SA, Barbera del Valles, Barcelona, Spain
Novartis Pharma Stein AG/SA, Stein, Switzerland
Product: Exelon
Active Ingredient(s): Rivastigmine hydrogen tartrate 9.6mg equivalent to 6mg rivastigmine
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Farmaceutica SA, Barbera del Valles, Barcelona, Spain
Novartis Pharma Stein AG/SA, Stein, Switzerland
Product: Ospexin
Active Ingredient(s): Cephalexin (monohydrate) 27.602mg/mL equivalent to 25mg/mL cephalexin
Dosage Form: Granules for oral suspension
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Ospexin
Active Ingredient(s): Cephalexin (monohydrate) 55.206mg/mL equivalent to 50mg/mL cephalexin
Dosage Form: Granules for oral suspension
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Biochemie GmbH, Kundl, Austria
Product: Razene
Active Ingredient(s): Cetirizine hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Gerard Laboratories, Dublin, Ireland
Product: Seroquel
Active Ingredient(s): Quetiapine fumarate 172.69mg equivalent 150mg quetiapine
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): AstraZeneca Pharmaceuticals LP, Newark, Delaware, United States of America
AstraZeneca UK Limited, Macclesfield, Cheshire, United Kingdom
Product: Seroquel
Active Ingredient(s): Quetiapine fumarate 345.39mg equivalent 300mg quetiapine
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer(s): AstraZeneca Pharmaceuticals LP, Newark, Delaware, United States of America
AstraZeneca UK Limited, Macclesfield, Cheshire, United Kingdom
Product: Vaniqa
Active Ingredient(s): Eflornithine hydrochloride 13.9%
Dosage Form: Topical cream
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer(s): Westwood-Squibb Pharmaceuticals Inc, Buffalo, New York, United States of America
Product: Zeldox IM
Active Ingredient(s): Ziprasidone mesylate 40.93mg equivalent to 30mg ziprasidone
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Dated this 29th day of September 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).