Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Actigall
Active Ingredient: Ursodeoxycholic acid 300mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Watson Laboratories Inc, Carmel NY, United States of America
Note: This consent is valid for two years from 7 September 2005.
Dated this 26th day of September 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).