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:
Active Ingredients:







Dosage Form:
New Zealand Sponsor:
Manufacturers:

Boostrix-IPV
Diphtheria toxoid, adsorbed 2.5Lf U
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 5Lf U
Suspension for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals (Saint-Amand-Les-Eaux), Saint-Amand-Les-Eaux, France

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturers:

Harvoni
Ledipasvir 90mg
Sofosbuvir 400mg
Film coated tablet
Gilead Sciences (NZ)
Patheon Inc, Mississauga, Canada
Gilead Sciences Ireland UC, Carrigtohill, Ireland

Dated this 19th day of May 2016.

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