WC500169468

Background
Flupirtine is an analgesic currently indicated for the treatment of acute pain (orally) and for
postoperative pain (intravenously) which was subject to the Art.107i referral procedure concluded in
July 2014. According to the EC decision Annex IV conditions the marketing authorisation holders for
flupirtine containing medicines, MAHs should carry out a post-authorisation safety study to evaluate
the effectiveness of the risk minimisation activities.
A protocol for such study was submitted for assessment by the PRAC by Meda Pharma.
Conclusion
The PRAC appointed Valerie Strassmann (DE) as Rapporteur for the assessment of the protocol and
adopted a timetable for review of the protocol for PRAC decision in June 2014.
7.1.3. Solutions for parenteral nutrition, combination - NUMETA G16%E EMULSION FOR
INFUSION and associated names (NAP)
Evaluation of an imposed PASS protocol
Regulatory details:
PRAC Rapporteur: Ulla Wändel Liminga (SE)
Administrative details:
Procedure scope: Evaluation of a PASS protocol (following conclusion of 107i Referral) on a multicentre,
non-interventional, uncontrolled, open-label, observational study in children to evaluate serum mg
levels associated with the intake of Numeta G 16% E
MAH(s): Baxter
Background
For background, see PRAC minutes 3-6 February 2014.
The protocol for a PASS submitted by the MAH was assessed by the Rapporteur.
Endorsement/Refusal of the protocol
The PRAC, having considered the draft protocol version 1.0- in accordance with Article 107n of
Directive 2001/83/EC, agreed that overall the design was acceptable, although further justification is
needed on the proposed small sample size. In addition, some other points also need to be addressed
before the protocol can be agreed. Therefore the PRAC objected to the draft protocol and
recommended that:
The MAH should submit a revised PASS protocol within 30 days to the EMA. A 30 daysassessment
timetable will be applied.
7.2. Protocols of PASS non-imposed in the marketing authorisation(s) 23
See Annex 16.2
23 In accordance with Article 107m of Directive 2001/83/EC, supervised by PRAC in accordance with Article 61a (6) of
Regulation (EC) No 726/2004
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/324055/2014 Page 44/73