WC500169468
WC500169468
WC500169468
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Regulatory details:<br />
PRAC rapporteur: Qun-Ying Yue (SE)<br />
PRAC Co-rapporteur: Karen Pernille Harg (NO)<br />
Administrative details:<br />
Procedure number: EMEA/H/A-107i/1395<br />
MAH(s): Martindale Pharma, various<br />
Background<br />
A referral procedure under Article 107i of Directive 2001/83/EC is ongoing for methadone medicinal<br />
products for oral use containing povidone (see PRAC minutes 7-10 April 2014). An ad-hoc expert<br />
meeting is to be organised.<br />
Summary of recommendation(s)/conclusions<br />
EMA secretariat informed the PRAC of the confirmed date of the ad-hoc expert group which is to be<br />
convened on 16 June 2014 in the framework of the procedure. The PRAC agreed on the expertise<br />
required at the meeting and on a list of questions for the experts, as well as a revised timetable to<br />
take into account this step (EMA/PRAC/186319/2014 rev.1 published on the EMA website). Members<br />
were invited to propose candidates from the Member States. EMA clarified that the current provisions<br />
in terms of the handling of potential conflict of interest will be applied.<br />
2.3. Procedures for finalisation<br />
None<br />
3. EU Referral Procedures for Safety Reasons: Other EU<br />
Referral Procedures<br />
3.1. Newly triggered Procedures<br />
3.1.1. Hydroxyzine (NAP)<br />
<br />
Review of the benefit-risk balance following notification by Hungary of a referral under Article<br />
31 of Directive 2001/83/EC, based on pharmacovigilance data<br />
Regulatory details:<br />
PRAC Rapporteur: Isabelle Robine (FR)<br />
PRAC Co-Rapporteur: Julia Pallos (HU)<br />
Administrative details:<br />
MAH(s): UCB, various<br />
Triggering MS: HU<br />
Background<br />
Following discussion at the April 2014 meeting of the CMDh (see CMDh Minutes of the 22-24 April 2014<br />
meeting) on the intention of one of the MAHs for hydroxyzine-containing medicines to submit a<br />
variation to delete two authorised indications ’preoperative anxiolysis’ and ‘sleep disorders’, and<br />
‘anxiety’ in paediatric patients and to reduce the highest recommended daily dose, the Hungarian<br />
Medicines Agency (GYEMSZI-OGYI) circulated a notification dated 25 April 2014 to initiate a referral<br />
procedure under Article 31 of Directive 2001/83/EC to review the benefit-risk of all hydroxyzinecontaining<br />
medicines in all indications, assessing in particular the pro-arrhythmogenic potential of<br />
hydroxyzine.<br />
Pharmacovigilance Risk Assessment Committee (PRAC)<br />
EMA/PRAC/324055/2014 Page 12/73
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