Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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: Symbicort 100/6 Turbuhaler
Active Ingredients: Budesonide 80µg/dose equivalent to 100µg metered dose
Formoterol fumarate 4.5µg/dose equivalent to 6µg metered dose
Dosage Form: Powder for inhalation
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden
Product: Symbicort 200/6 Turbuhaler
Active Ingredients: Budesonide 160µg/dose equivalent to 200µg metered dose
Formoterol fumarate 4.5µg/dose equivalent to 6µg metered dose
Dosage Form: Powder for inhalation
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden
Dated this 13th day of October 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).