WC500169468

More documents

Recommendations

Info

PRAC member PRAC alternate Country Outcome restriction following evaluation of e-DoI for the meeting Topics on the current Committee Agenda for which restriction applies Product/ substance Marin Banovac Croatia Full involvement Viola Macolić Šarinić Croatia Full involvement Nectaroula Cooper Cyprus Full involvement Jana Mladá Czech Republic Full involvement Torbjörn Callreus Denmark Full involvement Doris Stenver Denmark Full involvement Maia Uusküla Estonia Full involvement Kirsti Villikka Finland Full involvement Terhi Lehtinen Finland Full involvement Isabelle Robine France Full involvement Martin Huber Germany Full involvement Leonidas Klironomos Greece Cannot act as Rapporteur or Peer reviewer for: Julia Pallos Hungary Full involvement azithromycin, pegaptanib, bosutinib, bazedoxifene, tigecycline Hrefna Guðmundsdóttir Iceland Full involvement Almath Spooner Ireland Full involvement Ruchika Sharma Ireland Full involvement Carmela Macchiarulo Italy Full involvement Carmela Macchiarulo Italy Full involvement Andis Lacis Latvia Full involvement Jolanta Gulbinovic Lithuania Full involvement Jacqueline Genoux- Hames Luxembourg Full involvement Amy Tanti Malta Full involvement Sabine Straus Netherlands Full involvement Menno van der Elst Netherlands Full involvement Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/324055/2014 Page 70/73
PRAC member PRAC alternate Country Outcome restriction following evaluation of e-DoI for the meeting Topics on the current Committee Agenda for which restriction applies Product/ substance 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 Tatiana Magálová Slovakia Full involvement Gabriela Jazbec Slovenia Full involvement Miguel-Angel Maciá Spain Full involvement Dolores Montero Corominas Spain Full involvement Ulla Wändel Liminga Sweden Full involvement Qun-Ying Yue Sweden Full involvement June Munro Raine Chair Full involvement Julie Williams UK Full involvement Rafe Suvarna UK 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 Brigitte Keller- Stanislawski Hervé Le Louet Not applicable Cannot act as Rapporteur or Peer reviewer for: Full involvement Cannot act as Rapporteur or Peer reviewer for: Full involvement Full involvement quetiapine, saxagliptin, saxagliptin metformin, ceftaroline fosamil, dapagliflozin, exenatide fluticasone furoate, ofatumumab, pazopanib, raltegravir, vilanterol, Lennart Waldenlind Full involvement Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/324055/2014 Page 71/73
Page 1 and 2:
13 June 2014 EMA/PRAC/324055/2014 P
Page 3 and 4:
More detailed information on the ab
Page 5 and 6:
4.3.7. Tiotropium bromide (NAP) ...
Page 7 and 8:
13. Any other business ............
Page 9 and 10:
3.2.3. Elvitegravir - VITEKTA (CAP)
Page 11 and 12:
Administrative details: MAH(s): Ser
Page 13 and 14:
Discussion The PRAC noted the notif
Page 15 and 16:
Background A referral procedure und
Page 17 and 18:
A 60-day timetable was recommended
Page 19 and 20: Background Bisphosphonates and othe
Page 21 and 22: Administrative details: EPITT 17956
Page 23 and 24: Discussion The PRAC supported the c
Page 25 and 26: Summary of recommendation(s) The
Page 27 and 28: Background For background informati
Page 29 and 30: Procedure scope: Update of SmPC sec
Page 31 and 32: acceptable provided some requests f
Page 33 and 34: 6. Periodic Safety Update Reports (
Page 35 and 36: Summary of recommendation(s) and co
Page 37 and 38: Regulatory details: PRAC Rapporteur
Page 39 and 40: The current terms of the marketing
Page 41 and 42: Summary of recommendation(s) and co
Page 43 and 44: information, reflecting also the li
Page 45 and 46: 7.3. Results of PASS imposed in the
Page 47 and 48: Background The CHMP) adopted a nega
Page 49 and 50: 12.7.1.2. Progressive multifocal le
Page 51 and 52: 1. ANNEX I Risk Management Plans 1.
Page 53 and 54: Procedure scope: Update of RMP (ver
Page 57 and 58: 1.2.19. Ofatumumab - ARZERRA (CAP)
Page 59 and 60: Administrative details: Procedure n
Page 61 and 62: 2.1.9. Eltrombopag - REVOLADE (CAP)
Page 63 and 64: 2.1.19. Miglustat - ZAVESCA (CAP)
Page 65 and 66: Administrative details: Procedure n
Page 69: 3.5.5. Tigecycline - TYGACIL (CAP)
Page 73: Additional European experts partici
show all

WC500169468

Create successful ePaper yourself

Delete template?

Save as template?