Information to the Marketing Authorisation Holder – Oxynal-Targin and associated names
Information to the Marketing Authorisation Holder-Referral Art. 13, EMEA/H/A-13/1402 regarding Oxynal-Targin and associated names was finalised 23 December 2014.
http://ec.europa.eu/health/documents/community-register/html/ho25423.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).