WC500165698

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14.1.6. Mifepristone Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002830 Intended indication: Treatment of signs and symptoms of endogenous Cushing’s syndrome in adults 14.1.7. Nonacog gamma Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/003771 Intended indication: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency) 14.1.8. Perflubutane Evaluation of an RMP in the context of an initial marketing authorisation application procedure Status: for discussion and agreement of advice to CHMP Administrative details: Product number(s): EMEA/H/C/002347 Intended indication: Detection of coronary artery disease (CAD) 14.1.9. Secukinumab Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/003729 Intended indication: Treatment of plaque psoriasis 14.1.10. Simeprevir Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002777 Intended indication: Treatment of chronic hepatitis C (CHC) genotype 1 or genotype 4 infection 14.1.11. Simoctocog alfa Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002813 Intended indication: Treatment and prophylaxis of bleeding 14.1.12. Tacrolimus Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002655, Hybrid Intended indication: Prophylaxis of transplant rejection in adult kidney allograft recipients Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/253432/2014 Page 44/64
14.1.13. Tobramycin Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002633, Hybrid Intended indication: Treatment of chronic pulmonary infection 14.1.14. Trametinib Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002643 Intended indication: Treatment of unresectable or metastatic melanoma with a BRAF V600 mutation 14.2. Medicines already authorised As per agreed criteria, the PRAC endorsed without further plenary discussion the conclusions of the Rapporteur on the assessment of these updated versions of the RMP for the below mentioned medicines. RMP in the context of a variation – PRAC led procedure 14.2.1. Dabigatran – PRADAXA (CAP) Evaluation of an RMP in the context of a variation Regulatory details: PRAC Rapporteur: Doris Stenver (DK) Administrative details: Procedure number(s): EMEA/H/C/000829/II/0058 Procedure scope: Changes in the agreed study protocol for 1160.136 (SPAF MEA 025), a global registry program GLORIA-AF investigating patients with newly diagnosed non-valvular AF at risk for stroke receiving dabigatran MAH(s): Boehringer Ingelheim International GmbH 14.2.2. Human fibrinogen, human thrombin – EVICEL (CAP) Evaluation of an RMP in the context of a variation Regulatory details: PRAC Rapporteur: Brigitte Keller-Stanislawski (DE) Administrative details: Procedure number(s): EMEA/H/C/000898/II/0026 Procedure scope: Update of the RMP version 11 MAH(s): Omrix Biopharmaceuticals N. V. 14.2.3. Insulin glulisine – APIDRA (CAP) Evaluation of an RMP in the context of a variation Regulatory details: PRAC Rapporteur: Julie Williams (UK) Administrative details: Procedure number(s): EMEA/H/C/000557/II/0054 Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/253432/2014 Page 45/64
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 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: 14. ANNEX I Risk Management Plans 1
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 63 and 64: PRAC members and alternates Country

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