WC500185968

2.4. Planned public hearings
None
3. EU Referral Procedures for Safety Reasons: Other EU
Referral Procedures
3.1. Newly triggered Procedures
None
3.2. Ongoing Procedures
3.2.1. Dexibuprofen (NAP); ibuprofen (NAP)
Review of the benefit-risk balance following the notification by the United Kingdom of a referral
under Article 31 of Directive 2001/83/EC, based on pharmacovigilance data
Regulatory details:
PRAC Rapporteur: Dolores Montero Corominas (ES)
PRAC Co-Rapporteur: Julie Williams (UK)
Administrative details:
Procedure number(s): EMEA/H/A-31/1401
MAH(s): various
Background
A referral procedure under Article 31 of Directive 2001/83/EC is ongoing for ibuprofen (and for the
dextrorotatory enantiomer of ibuprofen, dexibuprofen)-containing medicines (see PRAC Minutes
December 2014).
Following receipt of a response from the Coxib and traditional NSAID Trialists' (CNT) Collaboration to a
list of questions adopted in December 2014, as well as the MAHs’ responses to a list of outstanding
issues, the Rapporteurs prepared an assessment report for discussion at the meeting.
Summary of recommendation(s)/conclusions
The PRAC discussed aspects relating to cardiovascular risk of ibuprofen/dexibuprofen at high doses
( ≥ 2400 mg/day for ibuprofen, ≥ 1200 mg/day for dexibuprofen) and the potential interaction with low
dose aspirin including the evaluation of the MAHs’ responses to the first list of outstanding issues and
the response from the CNT Collaboration. The PRAC agreed a second list of outstanding issues (LoOI)
to be addressed by the MAHs, together with a revised timetable for the procedure
(EMA/PRAC/332908/2014 Rev.2).
3.3. Procedures for finalisation
3.3.1. Codeine (NAP)
Review of the benefit-risk balance of codeine indicated for the treatment of cough in paediatric
patients following the notification by Germany of a referral under Article 31 of Directive
2001/83/EC, based on pharmacovigilance data
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/257790/2015 Page 12/89