Provisional Consent to the Distribution of a New Medicine

A corrigendum to this notice was published on 16 June 2020, Notice No. 2020-go2623.

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:*	Necon 0.5/35
Active Ingredients:	Ethinylestradiol 0.035mg Norethisterone 0.5mg
Dosage Form:	Tablet
New Zealand Sponsor:	Link Pharmaceuticals Limited
Manufacturer:	Teva Women’s Health Inc, Ohio, United States of America
Note: This consent is given subject to the following conditions: Provisional consent is to be granted for six months to address an urgent shortage in the market and only applies to batch number 1000134540. The medicine may only be marketed or distributed when no other norethisterone 0.5mg/ethinylestradiol 0.035mg tablet with consent under section 20 or section 23 of the Medicines Act 1981 is available in the New Zealand market, or if the medicine is required to maintain assurance of supply for PHARMAC funded oral contraceptives.
Note: This consent is valid for six months from the date of publication of this notice.

Dated this 3rd day of June 2020.

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

Publication Date: 4 Jun 2020

Tags: Medicines Act Provisional consent to the distribution of new medicines Health

Notice Number: 2020-go2377

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