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The next PSURs should be submitted in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal, unless changes apply as stated under relevant PSUR procedure(s). Evaluation of PSUR procedures 15.1.1. Alogliptin – VIPIDIA (CAP) Evaluation of a PSUR procedure Regulatory details: PRAC Rapporteur: Menno van der Elst (NL) Administrative details: Procedure number(s): EMEA/H/C/002182/PSUV/0004 MAH(s): Takeda Pharma A/S 15.1.2. Alogliptin, metformin – VIPDOMET (CAP) Evaluation of a PSUR procedure Regulatory details: PRAC Rapporteur: Menno van der Elst (NL) Administrative details: Procedure number(s): EMEA/H/C/002654/PSUV/0005 MAH(s): Takeda Pharma A/S 15.1.3. Alogliptin, pioglitazone – INCRESYNC (CAP) Evaluation of a PSUR procedure Regulatory details: PRAC Rapporteur: Menno van der Elst (NL) Administrative details: Procedure number(s): EMEA/H/C/002178/PSUV/0005 MAH(s): Takeda Pharma A/S 15.1.4. Apixaban – ELIQUIS (CAP) Evaluation of a PSUR procedure Regulatory details: PRAC Rapporteur: Menno van der Elst (NL) Administrative details: Procedure number(s): EMEA/H/C/002148/PSUV/0018 MAH(s): Bristol-Myers Squibb / Pfizer EEIG 15.1.5. Bosentan – STAYVEER (CAP), TRACLEER (CAP) Evaluation of a PSUR procedure Regulatory details: PRAC Rapporteur: Isabelle Robine (FR) Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 60/75
Administrative details: Procedure number(s): EMEA/H/C/002644/PSUV/0006, EMEA/H/C/000401/PSUV/0065 MAH(s): Marklas Nederlands BV (Stayveer), Actelion Registration Ltd. (Tracleer) 15.1.6. Bromfenac – YELLOX (CAP) Evaluation of a PSUR procedure Regulatory details: PRAC Rapporteur: Torbjörn Callréus (DK) Administrative details: Procedure number(s): EMEA/H/C/001198/PSUV/0007 MAH(s): Croma-Pharma GmbH 15.1.7. Conestat alfa – RUCONEST (CAP) Evaluation of a PSUR procedure Regulatory details: PRAC Rapporteur: Rafe Suvarna (UK) Administrative details: Procedure number(s): EMEA/H/C/001223/PSUV/0014 MAH(s): Pharming Group N.V 15.1.8. Copper ( 64 Cu) chloride – CUPRYMINA (CAP) Evaluation of a PSUR procedure Regulatory details: PRAC Rapporteur: Rafe Suvarna (UK) Administrative details: Procedure number(s): EMEA/H/C/002136/PSUV/0001 MAH(s): Sparkle Srl 15.1.9. Eribulin – HALAVEN (CAP) Evaluation of a PSUR procedure Regulatory details: PRAC Rapporteur: Ulla Wändel Liminga (SE) Administrative details: Procedure number(s): EMEA/H/C/002084/PSUV/0018 (with RMP version 3.0) MAH(s): Eisai Europe Ltd. 15.1.10. Erlotinib – TARCEVA (CAP) Evaluation of a PSUR procedure Regulatory details: PRAC Rapporteur: Doris Stenver (DK) Administrative details: Procedure number(s): EMEA/H/C/000618/PSUV/0036 (with RMP version 4.0) MAH(s): Roche Registration Ltd Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 61/75
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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
Page 9 and 10: 15.1.12. Human normal immunoglobuli
Page 11 and 12: 1. Introduction 1.1. Welcome and de
Page 13 and 14: Discussion The PRAC noted the notif
Page 15 and 16: The CMDh position on diacerein (see
Page 17 and 18: provides the best antimicrobial act
Page 19 and 20: Summary of recommendation(s) The M
Page 21 and 22: 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
Page 27 and 28: 5.2.3. Influenza vaccine (split vir
Page 29 and 30: Regulatory details: PRAC Rapporteur
Page 31 and 32: Summary of recommendation(s) and co
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
Page 47 and 48: EMA secretariat also made a proposa
Page 49 and 50: 14. ANNEX I Risk Management Plans M
Page 51 and 52: MAH(s): AbbVie Ltd. 14.1.12. Dabiga
Page 53 and 54: RMP in the context of a variation -
Page 57 and 58: Procedure scope: Introduction of a
Page 59: RMP evaluated in the context of a s
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
Page 73 and 74: PRAC member PRAC alternate Country
Page 75: Additional European experts partici
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