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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: Betadine Antiseptic Liquid Spray
Active Ingredient: Povidone-iodine 5.5%w/v equivalent to iodine 0.5%
Dosage Form: Topical spray
New Zealand Sponsor: Sanofi-aventis New Zealand Limited
Manufacturer: Mayne Pharma International Pty Limited, Adelaide, Australia
   
Product: Boostrix
Active Ingredients: Diphtheria toxoid, adsorbed 2IU
Pertactin 2.5mcg
Pertussis filamentous haemagglutinin 8mcg
Pertussis toxoid, adsorbed 8mcg
Tetanus toxoid, adsorbed 20IU
Dosage Form: Suspension for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France
   
Product: Boostrix-IPV
Active Ingredients: Diphtheria toxoid, adsorbed 2IU
Pertactin 2.5mcg
Pertussis filamentous haemagglutinin 8mcg
Pertussis toxoid, adsorbed 8mcg
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: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals (France), Saint-Amand-Les-Eaux, France
   
Product: Cerezyme
Active Ingredient: Imiglucerase 400U
Dosage Form: Powder for infusion
New Zealand Sponsor: Sanofi-aventis New Zealand Limited
Manufacturer: Genzyme Ireland Limited, Waterford, Ireland
   
Product: Zyban
Active Ingredient: Bupropion hydrochloride 150mg
Dosage Form: Modified release tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline LLC, North Carolina, United States of America

Dated this 15th day of July 2020.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on the 11 September 2013).