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Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of a New Medicine

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 medicine set out in the Schedule hereto:

Schedule

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Apo-Riluzole
Riluzole 50mg
Film coated tablet
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

Note: This consent is given subject to the following condition: Apo-Riluzole 50mg tablets can only be prescribed by specialist physicians who care for patients with motor neuron diseases, neurologists and palliative care physicians.

Also Note: This consent is valid for two years from the date of publication of this notice.

Dated this 26th day of November 2015.

CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).