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 set out in the Schedule hereto:
Schedule
Product: Rilutek
Active Ingredient: Riluzole 50mg
Dosage Form: Tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Winthrop Industrie, Compiegne, France
Note: This consent is given subject to the following condition:
- Rilutek may only be prescribed by specialist physicians who care for patients with Motor Neurone Disease, neurologists and palliative care physicians.
Note: This consent is valid for two years from the date of publication of this notice.
Product: Sodibic
Active Ingredient: Sodium bicarbonate 840mg
Dosage Form: Capsule
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Strides Arcolab Limited, Anekal Taluk, India
Note: This consent is valid for two years from the date of publication of this notice.
Dated this 3rd day of June 2010.
STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).