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).