Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Colgate Neutrafluor 5000 Plus Freshmint 5000ppm Fluoride Professional Toothpaste
Active Ingredient(s): Sodium fluoride 1.105%w/w equivalent to 5000ppm fluoride ion
Dosage Form: Toothpaste
New Zealand Sponsor: Colgate-Palmolive Limited
Manufacturer(s): Colgate Oral Pharmaceuticals, Dallas, Texas, United States of America
Product: Genotropin
Active Ingredient(s): Somatropin 5.8mg equivalent to 5mg somatropin
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacia Limited Company trading as Pharmacia
Manufacturer(s): Recip AB, Stockholm, Sweden
Product: Infanrix-hexa (Combination Product)
Active Ingredient(s): Adsorbed tetanus vaccine 40IU/dose
Diphtheria toxoid (adsorbed) 30IU/dose
Hepatitis B surface antigen (recombinant) 10µg/dose
Pertussis 69kDa outer membrane protein (Pertactin) 8µg/dose
Pertussis filamentous haemagglutinin 25µg/dose
Pertussis toxoid (adsorbed) 25µg/dose
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Dosage Form: Suspension for injection
Active Ingredient(s): Haemophilus influenzae type b vaccine 10µg/dose
Dosage Form: Powder for injection
Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Product: Infanrix-penta
Active Ingredient(s): Adsorbed tetanus vaccine 40IU/dose
Diphtheria toxoid (adsorbed) 30IU/dose
Hepatitis B surface antigen (recombinant) 10µg/dose
Pertussis 69kDa outer membrane protein (Pertactin) 8µg/dose
Pertussis filamentous haemagglutinin 25µg/dose
Pertussis toxoid (adsorbed) 25µg/dose
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Dosage Form: Suspension for injection
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium
Product: Miacalcic 200 IU Nasal Spray
Active Ingredient(s): Salcatonin 200IU/dose
Dosage Form: Solution for inhalation
New Zealand Sponsor: Novartis New Zealand Ltd
Manufacturer(s): MIPHARM S.p.A, Milano, Italy
Novartis Pharma AG, Basel, Switzerland
Novartis Pharma SA, Huningue, France
Dated this 11th day of April 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).