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: | 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).