WC500185968

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16.1.24. Infliximab – REMICADE (CAP) Evaluation of interim PASS results Regulatory details: PRAC Rapporteur: Ulla Wändel Liminga (SE) Administrative details: Procedure number(s): EMEA/H/C/000240/MEA 133.9 Procedure scope: Seventh annual paediatric inflammatory bowel disease (IBD) registry (DEVELOP) report MAH(s): Janssen Biologics B.V. 16.1.25. Oseltamivir – TAMIFLU (CAP) Evaluation of interim PASS results Regulatory details: PRAC Rapporteur: Kirsti Villikka (FI) Administrative details: Procedure number(s): EMEA/H/C/000402/MEA 102 Procedure scope: Annual review of the safety and efficacy of oseltamivir in immunocompromised patients up to final submission of the clinical trial NV20234 study report (treatment) as flu and season permits MAH(s): Roche Registration Ltd 16.1.26. Perampanel – FYCOMPA (CAP) Evaluation of interim PASS results Regulatory details: PRAC Rapporteur: Julie Williams (UK) Administrative details: Procedure number(s): EMEA/H/C/002434/MEA 004.2 Procedure scope: Annual progress report for a post-marketing observational safety study to evaluate the long-term safety and tolerability of Fycompa as add-on therapy in epilepsy patients (PASS Study E2007-G000-402) MAH(s): Eisai Europe Ltd. 16.1.27. Voriconazole – VFEND (CAP) Evaluation of interim PASS protocol Regulatory details: PRAC Rapporteur: Sabine Straus (NL) Administrative details: Procedure number(s): EMEA/H/C/000387/MEA 090 Procedure scope: Final feasibility assessment for a potential non-interventional study to evaluate the association between voriconazole use and squamous cell carcinoma (SCC) of the skin in children aged less than 18 years MAH(s): Pfizer Limited Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/257790/2015 Page 84/89
17. ANNEX I - Renewals of the Marketing Authorisation, Conditional Renewals and Annual Reassessments Based on the review of the available pharmacovigilance data for the medicines listed below and the CHMP Rapporteur’s assessment report, the PRAC considered that either the renewal of the marketing authorisation procedure could be concluded - and supported the renewal of their marketing authorisations for an unlimited or additional period, as applicable - or no amendments to the specific obligations of the marketing authorisation under exceptional circumstances for the medicines listed below were recommended. As per agreed criteria, the procedures were finalised at the PRAC level without further plenary discussion. 17.1.1. Antithrombin alfa – ATRYN (CAP) PRAC consultation on an annual reassessment of the marketing authorisation Regulatory details: PRAC Rapporteur: Arnaud Batz (FR) Administrative details: Procedure number(s): EMEA/H/C/000587/S/0021 (without RMP) MAH(s): GTC Biotherapeutics UK Limited 17.1.2. Fampridine – FAMPYRA (CAP) PRAC consultation on a conditional renewal of the marketing authorisation Regulatory details: PRAC Rapporteur: Sabine Straus (NL) Administrative details: Procedure number(s): EMEA/H/C/002097/R/0021 (without RMP) MAH(s): Biogen Idec Ltd. 17.1.3. Vismodegib – ERIVEDGE (CAP) PRAC consultation on a conditional renewal of the marketing authorisation Regulatory details: PRAC Rapporteur: Ulla Wändel Liminga (SE) Administrative details: Procedure number(s): EMEA/H/C/002602/R/0016 (without RMP) MAH(s): Roche Registration Ltd 18. ANNEX II - List of participants including any restrictions with respect to involvement of members / alternates / experts following evaluation of declared interests for the 9-12 March 2015 meeting. Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/257790/2015 Page 85/89
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10 April 2015 EMA/PRAC/257790/2015
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Table of contents 1. Introduction .
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6.2. Follow-up to PSUR procedures .
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12.15. Contacts of the PRAC with ex
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15.1.25. Pandemic influenza vaccine
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1. Introduction 1.1. Welcome and de
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Regulatory details: PRAC Rapporteur
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mainly reported in the published li
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During routine signal detection act
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Taking into account this first repo
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During routine signal detection act
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Summary of recommendation(s) The M
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4.3.5. Sodium containing formulatio
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Intended indication(s): Treatment i
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Procedure scope: Proposal for a new
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association of lenalidomide and sec
Page 33 and 34: 6. Periodic Safety Update Reports (
Page 35 and 36: The next PSUR should be submitted i
Page 37 and 38: 6.1.5. Mecasermin - INCRELEX (CAP)
Page 39 and 40: In the next PSUR, the MAH should pr
Page 41 and 42: The next PSUR should be submitted i
Page 43 and 44: Summary of recommendation(s) and co
Page 45 and 46: 6.1.14. Zoledronic acid - ACLASTA (
Page 47 and 48: Administrative details: Procedure n
Page 49 and 50: Although the PRAC recognised the re
Page 51 and 52: 10.3. Other requests 10.3.1. Antire
Page 53 and 54: 11. Other Safety issues for discuss
Page 55 and 56: 12.2.2. Pharmacovigilance Inspectio
Page 57 and 58: EudraVigilance data analysis system
Page 59 and 60: pharmacovigilance referrals, prepar
Page 61 and 62: account the comments raised. The PR
Page 63 and 64: 14.1.6. Ferric citrate coordination
Page 65 and 66: Procedure scope: Updated RMP (versi
Page 69 and 70: Procedure scope: Extension of indic
Page 71 and 72: Procedure scope: Grouped variation
Page 73 and 74: 15.1.7. Dabrafenib - TAFINLAR (CAP)
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Page 77 and 78: 15.1.27. Pyronaridine, artesunate -
Page 79 and 80: 16.1.3. Sodium, magnesium, potassiu
Page 83: MAH(s): Novartis Europharm Ltd 16.1
Page 87 and 88: Name Role Member state or affiliati
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WC500185968

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