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