Notice Type
Departmental
Notice Title

Renewal of Provisional Consent to the Distribution of Medicines

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:
Schedule
Product: Priligy
Active Ingredient: Dapoxetine hydrochloride 33.6mg equivalent to Dapoxetine base 30mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Te Arai Biofarma Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico
Note: This renewed consent is valid for two years from 12 November 2013.
Product: Priligy
Active Ingredient: Dapoxetine hydrochloride 67.2mg equivalent to Dapoxetine base 60mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Te Arai Biofarma Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico
Note: This renewed consent is valid for two years from 12 November 2013.
Dated this 19th day of September 2013.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).