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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:

Glassia
alpha1-Proteinase inhibitor 20mg/mL
Solution for injection
Shire New Zealand Limited
Kamada Limited, Beit Kama, Israel


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

Company to provide Medsafe with results of all post-marketing studies required by the FDA. The last of these should be accompanied by an application for approval pursuant to section 20 of the Medicines Act 1981.

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

Dated this 5th day of December 2017.

ALISON COSSAR, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on the 11th day of September 2013).