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 which was referred to the Minister of Health under the provisions of section 24(5) of the Act and set out in the Schedule hereto:

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*Product:*	Alyacen 1/35
Active Ingredients:	Ethinylestradiol 0.035mg Norethisterone 1mg
Dosage Form:	Tablet
New Zealand Sponsor:	ORSPEC Pharma Management Limited
Manufacturer:	Glenmark Pharmaceuticals Limited, Bardez, India
Provisional consent is granted until 17 October 2025. This consent is given subject to the following conditions: Provisional consent is granted for one year to address an urgent shortage in the market and only applies to batch numbers 20240218, 20240333 and 20240336. The medicine may only be marketed or distributed when no other norethisterone/ethinyl estradiol 1mg/0.035mg tablet medicine with consent under section 20 or section 23 of the Medicines Act 1981 is available in the New Zealand market, or to meet PHARMAC supply obligations.

Dated this 18th day of December 2024.

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

Provisional Consent to the Distribution of a New Medicine

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