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).