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: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico
Note: This renewed consent is valid for two years from 12 November 2011.
Product: Priligy
Active Ingredient: Dapoxetine hydrochloride 67.2mg equivalent to dapoxetine base 60mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico
Note: This renewed consent is valid for two years from 12 November 2011.
Dated this 10th day of August 2011.
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).