WC500169468

Background
A referral procedure under Article 20 of Regulation (EC) No 726/2004 is ongoing for Iclusig (ponatinib,
see PRAC minutes 2-5 December 2013). The PRAC (Co)-Rapporteurs prepared assessment reports on
the responses received to the list of questions agreed by the PRAC for discussion at the meeting.
Summary of recommendation(s)/conclusions
The PRAC discussed the preliminary conclusions reached by the Rapporteurs and agreed that additional
data and further analyses were needed in order to conclude on the most effective risk minimisation
regarding cardiovascular events that have been noted in clinical trials, and on the overall balance of
benefits and risks of use. Therefore the PRAC agreed on a list of outstanding issues to be addressed by
the MAH according to a revised timetable (EMA/PRAC/746118/2013 Rev.1).
3.2.3. Testosterone (NAP)
Review of the benefit-risk balance following notification by Estonia of a referral under Article 31
of Directive 2001/83/EC, based on pharmacovigilance data
Regulatory details:
PRAC Rapporteur: Torbjörn Callréus (DK)
PRAC Co-Rapporteur: Maia Uusküla (EE)
Administrative details:
Procedure number: EMEA/H/A-31/1396
MAH(s): various
Background
A referral procedure under Article 31 of Directive 2001/83/EC is ongoing for testosterone-containing
medicines (see PRAC minutes 7-10 April 2014). A request for extension of the previously agreed
timetable for providing a response to the agreed list of questions was requested by one of the MAHs
involved.
Summary of recommendation(s)/conclusions
The PRAC, having taken into account the MAH’s justification for an extension to the timetable,
considered that it was important to proceed in accordance to the already established timelines and
supported the decision to maintain the previously agreed timetable.
3.2.4. Valproate and related substances: sodium valproate, valproic acid, valproate
semisodium, valpromide (NAP)
• Review of the benefit-risk balance following notification by the UK of a referral under Article
31 of Directive 2001/83/EC based on pharmacovigilance data
Regulatory details:
PRAC Rapporteur: Sabine Straus (NL)
PRAC Co-Rapporteur: Julie Williams (UK)
Administrative details:
Procedure number: EMEA/H/A-31/1387
MAH(s): sanofi-aventis GmbH, various
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/324055/2014 Page 14/73