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: Tracleer
Active Ingredient: Bosentan 125mg
Dosage Form: Film coated tablet
New Zealand Sponsor: St Ives Medical
Manufacturer: Pantheon Inc, Mississauga, Ontario, Canada
Note: This consent is valid for two years from the date of publication of this notice.
Product: Tracleer
Active Ingredient: Bosentan 62.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: St Ives Medical
Manufacturer: Pantheon Inc, Mississauga, Ontario, Canada
Note: This consent is valid for two years from the date of publication of this notice.
Dated this 9th day of December 2004.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).