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
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Gardasil 9
Human Papillomavirus (HPV) 6 L1 Protein 30mcg
Human Papillomavirus (HPV) 11 L1 Protein 40mcg
Human Papillomavirus (HPV) 16 L1 Protein 60mcg
Human Papillomavirus (HPV) 18 L1 Protein 40mcg
Human Papillomavirus (HPV) 31 L1 Protein 20mcg
Human Papillomavirus (HPV) 33 L1 Protein 20mcg
Human Papillomavirus (HPV) 45 L1 Protein 20mcg
Human Papillomavirus (HPV) 52 L1 Protein 20mcg
Human Papillomavirus (HPV) 58 L1 Protein 20mcg
Suspension for injection
Merck Sharp & Dohme (New Zealand) Limited
Merck Sharp & Dohme Corp, Pennsylvania, United States of America
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Dated this 14th day of July 2016.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz