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 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 Disease, neurologists and palliative care physicians.

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

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

H5N1 Influenza Vaccine
Influenza Virus Type A haemagglutinin 30mcg
Suspension for injection
Seqirus (NZ) Limited
Seqirus Pty Limited, Melbourne, Australia

Note: This consent is given subject to the following condition:

  • The vaccine may only be marketed or distributed in accordance with the directives contained in the current version of the New Zealand Influenza Pandemic Action Plan.

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

Dated this 2nd day of February 2018.

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