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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Vannair
Active Ingredients: Budesonide 80mcg
Formoterol fumarate 4.5mcg
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca Dunkerque Production SCS, Dunkerque, France
Product: Vannair
Active Ingredients: Budesonide 160mcg
Formoterol fumarate 4.5mcg
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca Dunkerque Production SCS, Dunkerque, France
Dated this 6th day of June 2013.
DR MARK JACOBS, Acting 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).