Information to the Marketing Authorisation Holder – Emla cream

Referral Art. 30, EMEA/H/A-30/1388 regarding Emla cream was finalised 1 December 2014.

12.12.2014

Information to the Marketing Authorisation Holder-Referral Art. 30, EMEA/H/A-30/1388 regarding Emla cream was finalised 1 December 2014. 
   

http://ec.europa.eu/health/documents/community-register/html/ho25383.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).