Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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 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: Adacel
Active Ingredients: Diphtheria toxoid, adsorbed 2IU
Pertactin 3mcg
Pertussis filamentous haemagglutinin 5mcg
Pertussis fimbriae 2+3 5mcg
Pertussis toxoid, adsorbed 2.5mcg
Tetanus toxoid 20IU
Dosage Form: Suspension for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Pasteur Limited, Ontario, Canada
Product: Adacel Polio
Active Ingredients: Diphtheria toxoid, adsorbed 2IU
Pertactin 3mcg
Pertussis filamentous haemagglutinin 5mcg
Pertussis fimbriae 2+3 5mcg
Pertussis toxoid, adsorbed 2.5mcg
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid 20IU
Dosage Form: Suspension for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Sanofi Pasteur SA, Marcy L’Etoile, France
Sanofi Pasteur Limited, Ontario, Canada
Product: Pediacel
Active Ingredients: Diphtheria toxoid, adsorbed 15Lf U
Haemophilus influenzae type b polysaccharide 10mcg
Pertactin 3mcg
Pertussis filamentous haemagglutinin 20mcg
Pertussis fimbriae 2+3 5mcg
Pertussis toxoid, adsorbed 20mcg
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid 20mcg
Tetanus toxoid, adsorbed 5Lf U
Dosage Form: Suspension for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Pasteur Limited, Ontario, Canada
Product: Poliacel (Combination Product)
Active Ingredients: Diphtheria toxoid, adsorbed 15Lf U
Pertactin 3mcg
Pertussis filamentous haemagglutinin 20mcg
Pertussis fimbriae 2+3 5mcg
Pertussis toxoid, adsorbed 20mcg
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid, adsorbed 5Lf U
Dosage Form: Quadracel component Suspension for injection
Active Ingredient: Haemophilus influenzae type b polysaccharide 10mcg
Dosage Form: Act-HIB component Powder for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Pasteur Limited, Ontario, Canada
Product: Quadracel
Active Ingredients: Diphtheria toxoid, adsorbed 15Lf U
Pertactin 3mcg
Pertussis filamentous haemagglutinin 20mcg
Pertussis fimbriae 2+3 5mcg
Pertussis toxoid, adsorbed 20mcg
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid, adsorbed 5Lf U
Dosage Form: Suspension for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Pasteur Limited, Ontario, Canada
Product: Tripacel
Active Ingredients: Diphtheria toxoid, adsorbed 30IU
Pertactin 3mcg
Pertussis filamentous haemagglutinin 5mcg
Pertussis fimbriae 2+3 5mcg
Pertussis toxoid, adsorbed 10mcg
Tetanus toxoid, adsorbed 40IU
Dosage Form: Suspension for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Pasteur Limited, Ontario, Canada
Dated this 31st day of January 2013.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).