Information to the Marketing Authorisation Holder – Docetaxel (with alcohol in formulation)

30.12.2014

Information to the Marketing Authorisation Holder-Referral Art. 107i, EMEA/H/C/PSUSA/1152/201311 regarding Docetaxel (with alcohol in formulation) was finalised 23 December 2014.
 

http://ec.europa.eu/health/documents/community-register/html/ho25390.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).