Information to the Marketing Authorisation Holder – Colistimethate Alvogen

8.1.2015

Information to the Marketing Authorisation Holder-Referral Art. 31, EMEA/H/A-31/1383 regarding Colistimethate Alvogen 1 milljón a.e. og 2 milljónir a.e. stungulyfs-/innrennslisstofn, lausn was finalised 17 December 2014.
 

http://ec.europa.eu/health/documents/community-register/html/ho25421.htm

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).