WC500165698

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15.1.19. Orlistat – ALLI (CAP) Evaluation of a PSUR procedure Regulatory details: PRAC Rapporteur: Rafe Suvarna (UK) Administrative details: Procedure number(s): EMEA/H/C/000854/PSU 024 (with RMP version 13) MAH(s): Glaxo Group Ltd 15.1.20. Pioglitazone – ACTOS (CAP), GLUSTIN (CAP), NAP Pioglitazone, glimepiride – TANDEMACT (CAP) Pioglitazone, metformin – COMPETACT (CAP), GLUBRAVA (CAP) Evaluation of a PSUSA 30 procedure Regulatory details: PRAC Rapporteur: Almath Spooner (IE) Administrative details: Procedure number(s): EMEA/H/C/PSUSA/00002417/201307 MAH(s): Takeda Pharma A/S (Actos, Competact, Glubrava, Glustin, Tandemact), Cinfa Portugal (Pioglitazona Cinfa), Generis Farmaceutica (Pioglitazona Generis), Germed Farmaceutica, lda (Pioglitazona Germed), Torrent Pharma SRL (Pioglitazone Torrent), Heumann Pharma GmbH&Co Generica (Pioglitazone Torrent IT), Torrent Pharma GmbH (Pioglitazone Torrent NL), Torrent Pharma SRL (Pioglitazono Torrent LT), Terix Labs ltd (Zatrip) 15.1.21. Prasugrel – EFIENT (CAP) Evaluation of a PSUR procedure Regulatory details: PRAC Rapporteur: Doris Stenver (DK) Administrative details: Procedure number(s): EMEA/H/C/000984/PSU 032 (with RMP version 9.0) MAH(s): Eli Lilly Nederland B.V. 15.1.22. Romiplostim – NPLATE (CAP) Evaluation of a PSUR procedure Regulatory details: PRAC Rapporteur: Dolores Montero Corominas (ES) Administrative details: Procedure number(s): EMEA/H/C/000942/PSU 031 MAH(s): Amgen Europe B.V. 15.1.23. Telavancin – VIBATIV (CAP) Evaluation of a PSUR procedure Regulatory details: PRAC Rapporteur: Julie Williams (UK) 30 PSUR single assessment, referring to CAP, NAP Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/253432/2014 Page 54/64
Administrative details: Procedure number(s): EMEA/H/C/001240/PSU 012 MAH(s): Clinigen Healthcare Ltd 15.1.24. Telbivudine – SEBIVO (CAP) Evaluation of a PSUR procedure Regulatory details: PRAC Rapporteur: Isabelle Robine (FR) Administrative details: Procedure number(s): EMEA/H/C/000713/PSU 063 MAH(s): Novartis Europharm Ltd 15.1.25. Tocofersolan – VEDROP (CAP) Evaluation of a PSUR procedure Regulatory details: PRAC Rapporteur: Julie Williams (UK) Administrative details: Procedure number(s): EMEA/H/C/000920/PSU 012 MAH(s): Orphan Europe S.A.R.L. 15.1.26. Ulipristal – ESMYA (CAP) Evaluation of a PSUR procedure Regulatory details: PRAC Rapporteur: Ulla Wändel Liminga (SE) Administrative details: Procedure number(s): EMEA/H/C/002041/PSU 014 MAH(s): Gedeon Richter 15.1.27. Vemurafenib – ZELBORAF (CAP) Evaluation of a PSUR procedure Regulatory details: PRAC Rapporteur: Ulla Wändel Liminga (SE) Administrative details: Procedure number(s): EMEA/H/C/002409/PSU 028 MAH(s): Roche Registration Ltd 15.1.28. Vismodegib – ERIVEDGE (CAP) Evaluation of a PSUR procedure Regulatory details: PRAC Rapporteur: Ulla Wändel Liminga (SE) Administrative details: Procedure number(s): EMEA/H/C/002602/PSU 015 MAH(s): Roche Registration Ltd Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/253432/2014 Page 55/64
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 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 53: Administrative details: Procedure n
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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