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Administrative details: Product number(s): EMEA/H/C/002749 Intended indication: Radiolabelling of carrier molecules 14.1.7. Mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002705 Intended indication: Control of serum phosphorus levels in patients with end-stage renal disease (ESRD) 14.1.8. Naloxegol Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002810 Intended indication: Treatment of adult patients 18 years and older with opioid-induced constipation (OIC) including patients with inadequate response to laxatives 14.1.9. Ramucirumab Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002829, Orphan Intended indication: Treatment of gastric cancer 14.1.10. Tedizolid Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002846 Intended indication: Treatment of complicated skin and soft tissue infections (cSSTI) in adults 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 36 – PRAC-led procedure 14.1.11. Adalimumab – HUMIRA (CAP) Evaluation of an RMP in the context of a variation Regulatory details: PRAC Rapporteur: Ulla Wändel Liminga (SE) Administrative details: Procedure number(s): EMEA/H/C/000481/II/0130 Procedure scope: Update of the RMP (version 11.1) 36 In line with the revised variation regulation for submissions as of 4 August 2013 Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 50/75
MAH(s): AbbVie Ltd. 14.1.12. Dabigatran – PRADAXA (CAP) Evaluation of an RMP in the context of a variation Regulatory details: PRAC Rapporteur: Torbjörn Callréus (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 atrial fibrillation at risk for stroke receiving dabigatran. Consequent changes were done to the RMP (version 28.3) MAH(s): Boehringer Ingelheim International GmbH 14.1.13. Everolimus – VOTUBIA (CAP) Evaluation of an RMP in the context of a variation Regulatory details: PRAC Rapporteur: Martin Huber (DE) Administrative details: Procedure number(s): EMEA/H/C/002311/II/0021 Procedure scope: Update of the RMP (version 8.0) MAH(s): Novartis Europharm Ltd 14.1.14. Fondaparinux – ARIXTRA (CAP) Evaluation of an RMP in the context of a variation Regulatory details: PRAC Rapporteur: Qun-Ying Yue (SE) Administrative details: Procedure number(s): EMEA/H/C/000403/II/0061 Procedure scope: Update of the RMP (version 1.9) including an update of the current timeline for completion of the superficial vein thrombosis post-marketing observational study from December 2013 to December 2014 MAH(s): Glaxo Group Ltd 14.1.15. 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 Procedure scope: Update of RMP (version 6.0) MAH(s): Sanofi-aventis Deutschland GmbH 14.1.16. Prucalopride – RESOLOR (CAP) Evaluation of an RMP in the context of a variation Regulatory details: PRAC Rapporteur: Rafe Suvarna (UK) Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 51/75
Page 1 and 2: 10 July 2014 EMA/PRAC/438418/2014 P
Page 3 and 4: More detailed information on the ab
Page 5 and 6: 5.1.6. Insulin degludec, liraglutid
Page 7 and 8: 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: 14. ANNEX I Risk Management Plans M
Page 53 and 54: RMP in the context of a variation -
Page 57 and 58: Procedure scope: Introduction of a
Page 59 and 60: RMP evaluated in the context of a s
Page 61 and 62: Administrative details: Procedure n
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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