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emained favourable and a newly reduced dose of 10 mg up to three times daily orally for adults and
adolescents weighing 35 kg or more as described in the revised product information;where the
medicine is licensed in children and adolescents weighing less than 35 kg, it should be given orally at a
dose of 0.25 mg per kg bodyweight up to three times daily. Moreover measuring devices should be
included with liquid formulations to allow accurate dosing by bodyweight and the medicine should not
normally be used for longer than one week. A revision of other parts of the product information,
including the contraindications, interactions and warnings was also agreed. The PRAC also agreed on
further studies to be carried out to expand the knowledge on specific aspects of the benefit-risk profile
for domperidone, in particular in children.
Summary of recommendation(s)/conclusions
The PRAC adopted, by majority, the variation of the marketing authorisations for domperidonecontaining
medicines (and revocation for some of them: products supplying a dose of 20 mg orally,
and suppositories of 10 or 60 mg are no longer recommended for use and should be withdrawn, as
should combination products with cinnarizine) and adopted a recommendation to be considered by
CMDh for a position– see communication ‘PRAC recommends restricting use of domperidone’
EMA/129231/2014. A Direct Healthcare Professional Communication (DHPC) and communication plan
were also endorsed.
Twenty-nine members, voted in favour of the variation (or revocation as appropriate, see above) of the
marketing authorisation of domperidone-containing products together with Iceland and Norway, while
three members had divergent views 1 .
3.3.2. Zolpidem (NAP)
Review of the benefit-risk balance following notification by Italy of a referral under Article 31 of
Directive 2001/83/EC based on pharmacovigilance data
Regulatory details:
PRAC Rapporteur: Menno van der Elst (NL)
PRAC Co-Rapporteur: Jelena Ivanovic (IT)
Administrative details:
Procedure number: EMEA/H/A-31/1377
EPITT 17427 – Follow up December 2013
MAH(s): Sanofi-aventis, various
Background
A referral procedure under Article 31 of Directive 2001/83/EC for zolpidem-containing medicines (see
minutes of the PRAC 2-5 December 2013) was to be concluded. A final assessment of the data
submitted was produced by the Rapporteurs according to the agreed timetable.
1 The relevant AR containing the divergent views will be published on the EMA website once the procedure is fully
concluded.
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/253432/2014 Page 12/64