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: Genvoya
Active Ingredients: Cobicistat 150mg
Elvitegravir 150mg
Emtricitabine 200mg
Tenofovir alafenamide 10mg
Dosage Form: Tablet
New Zealand Sponsor: Gilead Sciences (NZ)
Manufacturers: Patheon Inc, Toronto Region Operations (TRO), Mississauga, Canada
Gilead Sciences Ireland UC, Carrigtohill, Ireland
   
Product: Vivotif Oral
Active Ingredient: Salmonella typhi strain TY21A Berna 2000million organisms
Dosage Form: Modified release capsule
New Zealand Sponsor: Seqirus (NZ) Limited
Manufacturer: Emergent BioSolutions Berna GmbH, Thorishaus, Switzerland


Dated this 28th day of February 2020.

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