WC500165698

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ANNEX II – List of participants: Including any restrictions with respect to involvement of members / alternates / experts following evaluation of declared interests for the 3-6 March 2014 meeting. PRAC members and alternates Country Outcome restriction following evaluation of e- DoI for the meeting Topics on the current Committee Agenda for which restriction applies Product/ substance Aleksandra Martinovic Austria Cannot act as Rapporteur or Peer reviewer for: Harald Herkner Austria Full involvement Jean-Michel Dogné Belgium Cannot act as Rapporteur or Peer reviewer for: Veerle Verlinden Belgium Full involvement Yuliyan Eftimov Bulgaria Full involvement Maria Popova- Bulgaria Full involvement Kiradjieva Viola Macolić Šarinić Croatia Full involvement Nectaroula Cooper Cyprus Full involvement Zena Gunther Cyprus Full involvement Jana Mladá Czech Republic Full involvement Line Michan Denmark Full involvement Doris Stenver Denmark Full involvement Katrin Kiisk Estonia Full involvement Maia Uusküla Estonia Full involvement Terhi Lehtinen Finland Full involvement Kirsti Villikka Finland Full involvement Isabelle Robine France Full involvement Martin Huber Germany Full involvement Valerie Strassmann Germany Full involvement Julia Pallos Hungary Full involvement Guðrún Kristín Iceland Full involvement Steingrímsdóttir Almath Spooner Ireland Full involvement Ruchika Sharma Ireland Full involvement Jelena Ivanovic Italy Full involvement Carmela Macchiarulo Italy Full involvement Andis Lacis Latvia Full involvement Jolanta Gulbinovic Lithuania Full involvement Jacqueline Genoux- Luxembourg Full involvement Hames Amy Tanti Malta Full involvement Sabine Straus Netherlands Full involvement Menno van der Elst Netherlands Full involvement Ingebjørg Buajordet Norway Full involvement Karen Pernille Harg Norway Full involvement Kamila Czajkowska Poland Full involvement Margarida Guimarães Portugal Full involvement Roxana Stroe Romania Full involvement agents acting on the reninangiotensin system, dabigatran agents acting on the reninangiotensin system, regorafenib, iloprost Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/253432/2014 Page 62/64
PRAC members and alternates Country Outcome restriction following evaluation of e- DoI for the meeting Topics on the current Committee Agenda for which restriction applies Product/ substance Tatiana Magálová Slovakia Full involvement Gabriela Jazbec Slovenia Full involvement Miguel-Angel Macia Spain Full involvement Dolores Montero Spain Full involvement Corominas Ulla Wändel Liminga Sweden Full involvement Qun-Ying Yue Sweden Full involvement June Munro Raine Chair Full involvement Julie Williams United Kingdom Full involvement Rafe Suvarna United Kingdom Full involvement Independent scientific experts nominated by the European Commission Country Outcome restriction following evaluation of e- DoI for the meeting: Topics on the current Committee Agenda for which restriction applies Product/ substance Jane Ahlqvist Rastad Marie Louise De Bruin Stephen Evans Birgitte Keller- Stanislawski Herve Le Louet Not applicable Full involvement Full involvement Cannot act as Rapporteur or Peer reviewer for: Full involvement Full involvement bupropion, belimumab, pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted), orlistat, human rotavirus Lennart Waldenlind Full involvement Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/253432/2014 Page 63/64
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10 April 2014 EMA/PRAC/253432/2014
Page 3 and 4:
Table of contents Note on access to
Page 5 and 6:
10.2. Timing and message content in
Page 7 and 8:
15.1.8. Dronedarone - MULTAQ (CAP)
Page 9 and 10:
1. Introduction 1.1. Welcome and de
Page 11 and 12: 3.2.2. Bromocriptine (NAP) Review
Page 13 and 14: Discussion The PRAC discussed the e
Page 15 and 16: Background Cefepime is a cephalospo
Page 17 and 18: Summary of recommendation(s) The M
Page 19 and 20: conducted in the US Veterans Affair
Page 21 and 22: Taken together, the available evide
Page 23 and 24: eported in 38.5% of the cases. Amon
Page 25 and 26: 5.2. Medicines already authorised R
Page 27 and 28: Summary of advice The RMP version
Page 29 and 30: Background Colistimethate sodium is
Page 31 and 32: The next PSUR should be submitted i
Page 33 and 34: Administrative details: Procedure n
Page 35 and 36: Summary of advice Based on the revi
Page 37 and 38: 10.3. Other requests None 11. Other
Page 39 and 40: The PRAC endorsed the final version
Page 41 and 42: 12.8. Post-authorisation Safety Stu
Page 43 and 44: 14. ANNEX I Risk Management Plans 1
Page 45 and 46: 14.1.13. Tobramycin Evaluation of
Page 47 and 48: 14.2.8. Amifampridine - FIRDAPSE (C
Page 49 and 50: Procedure scope: Grouping of three
Page 57 and 58: 16.2. Protocols of PASS non-imposed
Page 59 and 60: Procedure scope: Evaluation of fina
Page 61: Administrative details: Procedure n
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