Notice to applicants for variations resulting from the referral for ibuprofen- and dexibuprofen-containing medicines
The Co-Ordination Group for Mutual Recognition Procedure and Decentralised Procedure fur Human Medicines (CMDh) endorsed on 20 May 2015 by consensus the recommendation by EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) for ibuprofen- and dexibuprofen-containing medicines and are intended for systemic use. The recommendation is endorsed under Art. 31 of Directive 2001/83/EC of the European Parliament and Council (procedure number EMEA/H/A-31/1401) following to the referral procedure. Detailed information on this procedure, including the CMDh position is accessible on the EMA webpages.
HALMED is calling on all marketing authorisation holders in Croatia to submit an application for variation for all ibuprofen-containing-medicines, authorised nationally and intended for systemic use, no later than 16 October 2015.