Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product:
Active Ingredients:








Dosage Form:

New Zealand Sponsor:
Manufacturer:

Gardasil 9
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
Human Papillomavirus (HPV) 6 L1 Protein 30mcg
Suspension for injection
Merck Sharp & Dohme (New Zealand) Limited
Merck Sharp & Dohme Corp, Pennsylvania, United States of America

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Tobramycin Mylan
Tobramycin 80mg
Solution for injection
Mylan New Zealand Limited
Mylan Laboratories Limited, Bangalore, India

Dated this 11th day of February 2016.

CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).