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
26.11.2014
Datei
PD
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
26.11.2014
Datei
PD
16 May 2013
EMA/PRAC/137732/2013 Rev.1
Timetable for the procedure
Procedure under article 107i of Directive 2001/83/EC
Procedure no: flupirtine containing medicinal products
EMEA/H/A-107i
26.11.2014
Datei
PD
16 May 2013
EMA/PRAC/137732/2013 Rev.1
Timetable for the procedure
Procedure under article 107i of Directive 2001/83/EC
Procedure no: flupirtine containing medicinal products
EMEA/H/A-107i
26.11.2014
Datei
PD
08 March 2013
Rationale for the triggering of procedure
under Article 107i of Directive 2001/83/EC
on flupirtine
presented by the Federal Institute for Drugs and Medicina
26.11.2014
Datei
PD
!
"!
!
!
!
!
"#$!%&'(!)*"+!
!
,(-./012-3&-4!561!7061896&7(./06-!:(6'41&996!&-5!;6416-<&-4!561!
;608-5'&-4.58&61!=>1!?'&9(17(-@08'7(46!A1<-6(B(776'"!-8/0!;6C617&-4!
56.!D6E617FG(<(727.1(.(3F.!
26.11.2014
Datei
PD
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
26.11.2014
Datei
PD
_______________________________________________________ Chapter 3 Community referral
1
EUROPEAN COMMISSION
ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL
Consumer goods
Pharmaceuticals
26.11.2014
Datei
PD
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
26.11.2014
Datei
PD
05 December 2013
EMA/PRAC/127280/2013 Rev.2
Timetable for the procedure
Referral under article 31 of Directive 2001/83/EC resulting from
pharmacovigilance data
Domperidone containing medicinal
26.11.2014
Datei
PD
