WC500169468

Discussion
The PRAC noted the notification letter from the Hungarian Medicines Agency and agreed on a list of
questions to be addressed during the procedure as well as a timetable for conducting the review. The
PRAC also agreed that the PDCO should be consulted during the procedure and that a list of questions
to the PDCO will be agreed during the June 2014 PRAC meeting.
The PRAC appointed Isabelle Robine (FR) as Rapporteur and Julia Pallos (HU) as Co-Rapporteur for the
procedure.
Summary of recommendation(s)/conclusions
The Committee adopted a list of questions (EMA/PRAC/261900/2014) and a timetable for the
procedure (EMA/PRAC/261903/2014), both published on the EMA website.
3.2. Ongoing Procedures
3.2.1. Ambroxol (NAP); bromhexine (NAP)
Review of the benefit-risk balance following notification by Belgium of a referral under Article
31 of Directive 2001/83/EC, based on pharmacovigilance data
Regulatory details:
PRAC Rapporteur: Margarida Guimarães (PT)
PRAC Co-Rapporteurs: Jean-Michel Dogné (BE), Harald Herkner (AT)
Administrative details:
Procedure number: EMEA/H/A-31/1397
MAH(s): Boehringer Ingelheim, various
Background
A referral procedure under Article 31 of Directive 2001/83/EC is ongoing for ambroxol and
bromhexine-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.
3.2.2. Ponatinib - ICLUSIG (CAP)
Review of the benefit-risk balance following notification by the European Commission of a
referral under Article 20(8) of Regulation (EC) No 726/2004, based on pharmacovigilance data
Regulatory details:
PRAC Rapporteur: Rafe Suvarna (UK)
PRAC Co-Rapporteur: Ulla Wändel Liminga (SE)
Administrative details:
Procedure number: EMEA/H/C/002695/A-20/0003
MAH(s): Ariad Pharma Ltd
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/324055/2014 Page 13/73