WC500165698

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17. ANNEX I Renewals of the Marketing Authorisation, Conditional Renewals and Annual Reassessments ....................................................... 59 17.1.1. Certolizumab pegol – CIMZIA (CAP) ................................................................. 59 17.1.2. Characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins – CHONDROCELECT (CAP) .................................................................. 60 17.1.3. Clopidogrel – CLOPIDOGREL DURA (CAP), CLOPIDOGREL MYLAN (CAP) ................ 60 17.1.4. Clopidogrel – CLOPIDOGREL KRKA (CAP), CLOPIDOGREL KRKA D.D. (CAP), ZYLAGREN (CAP), ZYLLT (CAP) ................................................................................... 60 17.1.5. Clopidogrel – CLOPIDOGREL TAD (CAP) ............................................................ 60 17.1.6. Clopidogrel – CLOPIDOGREL TEVA (CAP) .......................................................... 60 ANNEX II – List of participants: ................................................................. 62 ANNEX III – List of abbreviations .............................................................. 64 Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/253432/2014 Page 8/64
1. Introduction 1.1. Welcome and declarations of interest of members, alternates and experts The Chairperson opened the meeting, welcoming all participants to the 3-6 March 2014 meeting of the PRAC. Based on the declarations of interest submitted by the Committee members, alternates and experts and based on the topics in the agenda of the current meeting, the Committee Secretariat announced the restricted involvement of some Committee members for the related upcoming discussions; in accordance with the Agency’s policy on the handling of conflicts of interests, participants in this meeting were asked to declare any changes, omissions or errors to the already declared interests on the matters for discussion. No new or additional conflicts were declared(see Annex II). Discussions, deliberations and voting took place in full respect of the restricted involvement of Committee members and experts in line with the relevant provisions of the Rules of Procedure. All decisions taken at this meeting were made in the presence of a quorum of members (i.e. 24 or more members were present in the room). All decisions, recommendations and advice were agreed unanimously, unless otherwise specified. The PRAC Chair welcomed Rafe Suvarna as new alternate for the UK and Hrefna Guðmundsdóttir as alternate for Iceland. 1.2. Adoption of agenda of the meeting of 3-6 March 2014 The agenda was adopted with some modifications upon request from the members of the Committee and the EMA secretariat. 1.3. Minutes of the previous PRAC meeting on 3-6 February 2014 The minutes were adopted with some amendments received during the consultation phase and will be published on the EMA website. Post-meeting note: the PRAC minutes of the meeting held on 3-6 February 2014 EMA/PRAC/158631/2014 were published on the EMA website on 19 March 2014. 2. EU Referral Procedures for Safety Reasons: Urgent EU Procedures None 3. EU Referral Procedures for Safety Reasons: Other EU Referral Procedures 3.1. Newly triggered Procedures None Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/253432/2014 Page 9/64
Page 1 and 2: 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: 15.1.8. Dronedarone - MULTAQ (CAP)
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
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Procedure scope: Evaluation of fina
Page 61 and 62:
Administrative details: Procedure n
Page 63 and 64:
PRAC members and alternates Country
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