Notice Type
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:


Product: Biktarvy
Active Ingredients: Bictegravir sodium 52.45mg equivalent to bictegravir 50mg
Emtricitabine 200mg
Tenofovir alafenamide fumarate 28.04mg equivalent to tenofovir alafenamide 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Gilead Sciences (NZ)
Manufacturers: Rottendorf Pharma GmbH, Ennigerloh, Germany
Gilead Sciences Ireland UC, Carrigtohill, Ireland
Product: Hayfexo
Active Ingredient: Fexofenadine hydrochloride 180mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy's New Zealand Limited
Manufacturer: Dr Reddy's Laboratories Limited, Hyderabad, India

Dated this 28th day of June 2021.

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