Information to the Marketing Authorisation Holder – Zolpidem

23.7.2014

Information to the Marketing Authorisation Holder-Referral Art. 31, EMEA/H/A-31/1377 regarding Zolpidem was finalised 24 June 2014.

http://ec.europa.eu/health/documents/community-register/html/ho25252.htm

A list of medicinal products with Marketing Authorisation in Iceland.

Approved Icelandic texts.

The applicant shall apply for this change either as IA(IN) C.I.1.a. (using the proposed Icelandic text unchanged) or IB.C.I.1.a. (if the proposed Icelandic text must be changed to adapt to the relevant text).