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 medicines set out in the Schedule hereto:
Schedule
Product: Orgalutran
Active Ingredient: Ganirelix 0.5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Note: This consent is valid for two years from 9 November 2006.
Product: Tracleer
Active Ingredient: Bosentan 125mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Patheon Inc, Mississauga, Ontario, Canada
Note: This consent is valid for two years from 16 December 2006.
Product: Tracleer
Active Ingredient: Bosentan 62.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Patheon Inc, Mississauga, Ontario, Canada
Note: This consent is valid for two years from 16 December 2006.
Product: Ursofalk
Active Ingredient: Ursodeoxycholic acid 250mg
Dosage Form: Capsule
New Zealand Sponsor: St Ives Medical
Manufacturer: Losan Pharma GmbH, Neuenburg, Germany
Note: This consent is valid for two years from 28 October 2006.
Dated this 31st day of August 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).