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: Emtricitabine/Tenofovir disoproxil
Active Ingredients: Emtricitabine 200mg
Tenofovir disoproxil succinate 300.6mg equivalent to tenofovir disoproxil 245mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Remedica Limited, Limassol, Cyprus
   
Product: Erlyand
Active Ingredient: Apalutamide 60mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico
   
Product: Tenofovir disoproxil tablets
Active Ingredient: Tenofovir disoproxil succinate 300.6mg equivalent to tenofovir disoproxil 245mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Remedica Limited, Limassol, Cyprus


Dated this 27th day of November 2020.

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