Notice Type
Departmental
Notice Title

Consent to the Distribution of a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out
in the Schedule hereto:
Schedule
Product: Gardasil
Active Ingredients: Human Papillomavirus (HPV) 11 L1 Protein 80µg/mL
Human Papillomavirus (HPV) 16 L1 Protein 80µg/mL
Human Papillomavirus (HPV) 18 L1 Protein 40µg/mL
Human Papillomavirus (HPV) 6 L1 Protein 40µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme Corp, Pennsylvania, United States of America
Merck Sharp & Dohme BV, Haarlem, The Netherlands
Dated this 22nd day of March 2012.
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).