In the notice published in the New Zealand Gazette, 12 November 2009, No. 164, page 3972, the first entry for Priligy is to be deleted from Full Consent section 20, and be placed in Provisional Consent section 23 as hereunder:
Provisional Consent to the Distribution of a New Medicine
Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Priligy
Active Ingredient: Dapoxetine hydrochloride 33.6mg equivalent to 30mg dapoxetine
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Mamey Ward, Gurabo, Puerto Rico
Dated this 11th day of December 2009.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).