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30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
An agency of the European Union
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Send a question via our website
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07 March 2013
EMA/PRAC/124198/2013
PRAC List of questions
To be addressed by the marketing authorisation holder(s) for domperidone
containing medicinal products
Article 31 of Directive 2001/83
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06 March 2014
EMA/152501/2014
Pharmacovigilance Risk Assessment Committee (PRAC)
Assessment report
Procedure under Article 31 of Directive 2001/83/EC
Domperidone-containing medicin
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7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom
An agency of the European Union
Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7129
E-mail info@ema.europa.eu Webs
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7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom
An agency of the European Union
Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7129
E-mail info@ema.europa.eu Webs
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Annex II
Scientific conclusions and grounds for revocation or variation to the terms
of the marketing authorisations, as applicable, and detailed explanation for
the differences from the PRAC
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1 September 2014
EMA/465179/2014
Restrictions on the use of domperidone-containing
medicines
On 23 April 2014, the Co-ordination Group for Mutual Recognition and Decentralised Procedures –
Hu
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