1u7kf0g

The PRAC discussed the conclusion reached by the Rapporteurs and agreed on a list of outstanding
issues, to complete the review and to address a few remaining aspects, to be addressed in an
expedited way in accordance with a revised timetable (EMA/PRAC/493206/2013 rev.2).
3.2.2. Hydroxyzine (NAP)
Review of the benefit-risk balance following notification by Hungary of a referral under Article
31 of Directive 2001/83/EC, based on pharmacovigilance data
Regulatory details:
PRAC Rapporteur: Isabelle Robine (FR)
PRAC Co-Rapporteur: Julia Pallos (HU)
Administrative details:
Procedure number: EMEA/H/A-31/1400
MAH(s): UCB, various
Background
A referral procedure under Article 31 of Directive 2001/83/EC is ongoing for hydroxyzine-containing
medicines (see, PRAC Minutes 8-11 May 2014). The PRAC previously agreed that input from the
Paediatric Committee (PDCO) was needed on the procedure and a draft list of questions was prepared
by the Rapporteur.
Summary of recommendation(s)/conclusions
The PRAC discussed and agreed a list of questions to be transmitted to the PDCO in order to obtain
additional information on the clinical use of these products in paediatric patients.
3.3. Procedures for finalisation
None
3.4. Article 5(3) of Regulation (EC) No 726/2004 as amended: PRAC advice
on CHMP request
None
3.5. Others
3.5.1. Diacerein (NAP)
Review of recommendations of the referral procedure under Article 31 of Directive 2001/83/EC
adopted in March 2014, at the request of the European Commission
Regulatory details:
PRAC Rapporteur (re-examination): Margarida Guimarães (PT)
PRAC Co-Rapporteur (re-examination): Harald Herkner (AT)
Administrative details:
Procedure number: EMEA/H/A-31/1349
MAH(s): Negma-Wockhardt, TRB Chemedica, various
Background
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/438418/2014 Page 14/75