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 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: Ipol
Active Ingredients: Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Dosage Form: Suspension for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Sanofi Pasteur SA, Marcy L'Etoile, France
Sanofi Pasteur SA, Val-De-Reuil, France
Product: Lidocaine
Active Ingredients: Glucose 5%
Lidocaine hydrochloride monohydrate 0.4%
Dosage Form: Solution for infusion
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare of Puerto Rico, Jayuya, Puerto Rico
Dated this 8th day of July 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).