Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of New Medicines

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: Amirol
Active Ingredient: Amitriptyline hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Remedica Limited, Limassol, Cyprus
Note: This consent is valid for two years from the date of publication of this notice.
Product: Amirol
Active Ingredient: Amitriptyline hydrochloride 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Remedica Limited, Limassol, Cyprus
Note: This consent is valid for two years from the date of publication of this notice.
Product: Ixempra
Active Ingredient: Ixabepilone 15mg
Dosage Forms: Powder for injection
Diluent
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Baxter Oncology GmbH, Halle-Kunsebeck, Germany
Note: This consent is valid for two years from the date of publication of this notice.
Product: Ixempra
Active Ingredient: Ixabepilone 45mg
Dosage Forms: Powder for injection
Diluent
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Baxter Oncology GmbH, Halle-Kunsebeck, Germany
Note: This consent is valid for two years from the date of publication of this notice.
Dated this 22nd day of August 2008.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).