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: Intragam P
Active Ingredient: Immunoglobulin G 0.06g/mL
Dosage Form: Solution for injection
New Zealand Sponsor: CSL New Zealand Limited
Manufacturer: CSL Limited, Broadmeadows, Victoria, Australia
Product: Nicorette Citrus Gum
Active Ingredient: Nicotine 2mg
Dosage Form: Chewing gum
New Zealand Sponsor: Pharmacia Limited Company
Manufacturer: Pharmacia AB, Helsingborg, Sweden
Product: Nicorette gum
Active Ingredient: Nicotine 2mg
Dosage Form: Chewing gum
New Zealand Sponsor: Pharmacia Limited Company
Manufacturers: Pharmacia AB, Helsingborg, Sweden Scan-Gum Aps, Esbjerg, Denmark
Product: Nicorette gum
Active Ingredient: Nicotine 4mg
Dosage Form: Chewing gum
New Zealand Sponsor: Pharmacia Limited Company
Manufacturers: Pharmacia AB, Helsingborg, Sweden Scan-Gum Aps, Esbjerg, Denmark
Product: Nicorette Inhaler
Active Ingredient: Nicotine 10mg
Dosage Form: Volatile liquid for inhalation
New Zealand Sponsor: Pharmacia Limited Company
Manufacturer: Pharmacia AB, Helsingborg, Sweden
Product: Nicorette Mint gum
Active Ingredient: Nicotine 2mg
Dosage Form: Chewing gum
New Zealand Sponsor: Pharmacia Limited Company
Manufacturers: Pharmacia AB, Helsingborg, Sweden Scan-Gum Aps, Esbjerg, Denmark
Product: Nicorette Mint gum
Active Ingredient: Nicotine 4mg
Dosage Form: Chewing gum
New Zealand Sponsor: Pharmacia Limited Company
Manufacturers: Pharmacia AB, Helsingborg, Sweden Scan-Gum Aps, Esbjerg, Denmark
Product: Nicorette
Active Ingredient: Nicotine 16.6mg
Dosage Form: Transdermal patch, systemic effect
New Zealand Sponsor: Pharmacia Limited Company
Manufacturer: Pharmacia AB, Helsingborg, Sweden
Product: Nicorette
Active Ingredient: Nicotine 24.9mg
Dosage Form: Transdermal patch, systemic effect
New Zealand Sponsor: Pharmacia Limited Company
Manufacturer: Pharmacia AB, Helsingborg, Sweden
Product: Nicorette
Active Ingredient: Nicotine 8.3mg
Dosage Form: Transdermal patch, systemic effect
New Zealand Sponsor: Pharmacia Limited Company trading
Manufacturer: Pharmacia AB, Helsingborg, Sweden
Product: Nicotrol
Active Ingredient: Nicotine 0.3125mg/h
Dosage Form: Transdermal patch, systemic effect
New Zealand Sponsor: Pharmacia Limited Company
Manufacturer: Pharmacia AB, Helsingborg, Sweden
Product: Nicotrol
Active Ingredient: Nicotine 0.625mg/h
Dosage Form: Transdermal patch, systemic effect
New Zealand Sponsor: Pharmacia Limited Company
Manufacturer: Pharmacia AB, Helsingborg, Sweden
Product: Nicotrol
Active Ingredient: Nicotine 0.9375mg/h
Dosage Form: Transdermal patch, systemic effect
New Zealand Sponsor: Pharmacia Limited Company
Manufacturer: Pharmacia AB, Helsingborg, Sweden
Product: NovoRapid NovoLet
Active Ingredient: Insulin aspart 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Copenhagen, Denmark
Product: NovoRapid Penfill
Active Ingredient: Insulin aspart 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: NovoRapid
Active Ingredient: Insulin aspart 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Priorix
Active Ingredients: Measles vaccine, Schwarz strain 1,000CCID50
Mumps virus, live attenuated, RIT 4385 5,012CCID50
Rubella virus, Wistar RA27/3 strain 1,000CCID50
Dosage Form: Powder for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline Biologicals, Rixensart, Belgium GlaxoSmithKline Biologicals, Genval, Belgium Sachsisches Serumwerk Dresden, Dresden, Germany
Product: Varilrix Vaccine
Active Ingredient: Varicella vaccine 2,000PFU
Dosage Form: Solution for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Biologicals, Rixensart, Belgium
Product: Xenical
Active Ingredient: Orlistat 120mg
Dosage Form: Capsule
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland Hoffmann-La Roche Inc, Nutley, New Jersey, United States of America Roche Prodotti SpA, Segrate, Milan, Italy
Dated this 10th day of February 2003.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).