Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of New Medicines

Pursuant to section 23(1) 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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Exjade
Active Ingredient: Deferasirox 125mg
Dosage Form: Dispersible tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Note: This consent is valid to 27 May 2012.
Product: Exjade
Active Ingredient: Deferasirox 250mg
Dosage Form: Dispersible tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Note: This consent is valid to 27 May 2012.
Product: Exjade
Active Ingredient: Deferasirox 500mg
Dosage Form: Dispersible tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Note: This consent is valid to 27 May 2012.
Dated this 15th day of September 2011.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).