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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 Cannot act as Rapporteur or Peer reviewer for: naloxegol; olaparib; saxagliptin, metformin; ceftaroline fosamil Marie Louise De Bruin Full involvement Stephen Evans Brigitte Keller- Stanislawski Not applicable Cannot act as Rapporteur or Peer reviewer for: Full involvement fondaparinux; ofatumumab; pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted); pneumococcal polysaccharide conjugate vaccine (adsorbed); prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted); human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed); eltrombopag; pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) Hervé Le Louet Full involvement Lennart Waldenlind Full involvement Health care professiona ls and patients members Country Outcome restriction following evaluation of e-DoI for the meeting: Topics on the current Committee Agenda for which restriction applies Product/substance Filip Babylon Full involvement Marco Greco Full involvement Kristen Myhr Full involvement Albert van der Zeijden Cannot act as Rapporteur or Peer Reviewer in relation to any medicinal product from the relevant companies for which his institution receives grants as listed in the published Declaration of Interest (2013-05- 30) http://www.ema.europa.eu/docs/en_GB/do cument_library/contacts/avanderzeijden_DI .pdf Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 74/75
Additional European experts participating at the meeting for specific Agenda items Country Arnaud Batz Céline Druet Martin Tribout Thomas Grüger Vahid Taravati Giuseppe Rosano Marjolein Willemen Sabine Leh César de la Fuente Lena Hansson Karl-Mikael Kälkner Inga Bellahn Eleni Gaki Max Lagnado Angelika Siapkara France France France Germany Germany Italy Netherlands Norway Spain Sweden Sweden United Kingdom United Kingdom United Kingdom United Kingdom No restrictions were identified for the participation of European experts attending the PRAC meeting for discussion on specific agenda items ANNEX III – List of abbreviations For a List of the acronyms and abbreviations used in the PRAC (Pharmacovigilance Risk Assessment Committee) Minutes used in the PRAC minutes, see: www.ema.europa.eu Home>About Us>Committees>PRAC Agendas, minutes and highlights Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 75/75
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10 July 2014 EMA/PRAC/438418/2014 P
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More detailed information on the ab
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5.1.6. Insulin degludec, liraglutid
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12.8.1. Post-Authorisation Safety S
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15.1.12. Human normal immunoglobuli
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1. Introduction 1.1. Welcome and de
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Discussion The PRAC noted the notif
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The CMDh position on diacerein (see
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provides the best antimicrobial act
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Summary of recommendation(s) The M
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Summary of recommendation(s) The M
Page 23 and 24: The MAHs of nationally authorised m
Page 25 and 26: 5.1.6. Insulin degludec, liraglutid
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Page 33 and 34: effects with frequencies unknown, a
Page 39 and 40: 7.2. Protocols of PASS non-imposed
Page 43 and 44: MAH(s): Almirall, S.A., Temis Farma
Page 45 and 46: 12. Organisational, regulatory and
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Page 49 and 50: 14. ANNEX I Risk Management Plans M
Page 51 and 52: MAH(s): AbbVie Ltd. 14.1.12. Dabiga
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Page 57 and 58: Procedure scope: Introduction of a
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Page 63 and 64: 15.1.16. Irbesartan, hydrochlorothi
Page 67 and 68: MAH(s): Janssen-Cilag International
Page 71 and 72: Administrative details: Procedure n
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