Information to the Marketing Authorisation Holders - Renin-angiotensin system acting agents 

Referral Art. 31, EMEA/H/A-31/1370 regarding RAS (Renin-angiotensin system) -acting agents was finalised 8 September 2014.

18.9.2014

Information to the Marketing Authorisation Holder-Referral Art. 31, EMEA/H/A-31/1370 regarding RAS (Renin-angiotensin system) -acting agents was finalised 8 September 2014.

http://ec.europa.eu/health/documents/community-register/html/ho25273.htm

Lists of medicinal products with Marketing Authorisation in Iceland:

RAS-acting agents (ACE)

RAS-acting agents (ARBs)

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).