WC500185968

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MAH(s): Pfizer Limited 16.1.16. Etanercept – ENBREL (CAP) Evaluation of PASS results Regulatory details: PRAC Rapporteur: Rafe Suvarna (UK) Administrative details: Procedure number(s): EMEA/H/C/000262/II/0180 (without RMP) Procedure scope: Clinical study report for study British Society for Rheumatology Biologics register (BSRBR) MAH(s): Pfizer Limited 16.1.17. Human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed) – GARDASIL (CAP), SILGARD (CAP) Evaluation of PASS results Regulatory details: PRAC Rapporteur: Qun-Ying Yue (SE) Administrative details: Procedure number(s): EMEA/H/C/000703/WS0698/0056/G, EMEA/H/C/000732/WS0698/0052/G (with RMP) Procedure scope: Final report for vaccine impact population study in 4 Nordic countries for P033 and the extension of the due date to December 2015 (instead of June 2015) for submission of final study report MEA 20.6 for Protocol 018 (long-term follow up study in adolescents) MAH(s): Sanofi Pasteur MSD SNC 16.1.18. Pandemic influenza vaccine H1N1 (split virion, inactivated, adjuvanted) – PANDEMRIX (CAP) Evaluation of PASS results Regulatory details: PRAC Rapporteur: Rafe Suvarna (UK) Administrative details: Procedure number(s): EMEA/H/C/000832/II/0077 (without RMP) Procedure scope: Report on a retrospective pharmacoepidemiological study in Canada (Quebec) and follow-up cases. This submission fulfils condition ANX-115 of the marketing authorisation. Annex II is updated accordingly MAH(s): GlaxoSmithKline Biologicals 16.1.19. Imatinib – GLIVEC (CAP) Evaluation of interim PASS results Regulatory details: PRAC Rapporteur: Dolores Montero Corominas (ES) Administrative details: Procedure number(s): EMEA/H/C/000406/ANX 191.1 Procedure scope: First progress report on the European observational registry collecting efficacy and safety data in newly diagnosed paediatric Philadelphia positive (Ph+) acute lymphoblastic leukemia (ALL) patients treated with chemotherapy + imatinib ± hematopoietic stem cell treatment (±HSCT) (study STI571I2201) Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/257790/2015 Page 82/89
MAH(s): Novartis Europharm Ltd 16.1.20. Azilsartan medoxomil – EDARBI (CAP) Evaluation of interim PASS results Regulatory details: PRAC Rapporteur: Menno van der Elst (NL) Administrative details: Procedure number(s): EMEA/H/C/002293/MEA 001.2 Procedure scope: First annual study report on a drug utilisation study one and five years post-launch in the EU MAH(s): Takeda Pharma A/S 16.1.21. Bazedoxifene – CONBRIZA (CAP) Evaluation of interim PASS results Regulatory details: PRAC Rapporteur: Martin Huber (DE) Administrative details: Procedure number(s): EMEA/H/C/000913/MEA 012.6 Procedure scope: Third progress report on PASS study B1781044: cohort study of venous thromboembolism and other clinical endpoints among osteoporotic women prescribed bazedoxifene, bisphosphonates or raloxifene in Europe MAH(s): Pfizer Limited 16.1.22. Boceprevir – VICTRELIS (CAP) Evaluation of interim PASS results Regulatory details: PRAC Rapporteur: Arnaud Batz (FR) Administrative details: Procedure number(s): EMEA/H/C/002332/MEA 017.6 Procedure scope: Third interim status report on observational PASS of Victrelis (boceprevir) amongst chronic hepatitis C patients (P08518) MAH(s): Merck Sharp & Dohme Limited 16.1.23. Indacaterol – HIROBRIZ BREEZHALER (CAP), ONBREZ BREEZHALER (CAP), OSLIF BREEZHALER (CAP) Evaluation of interim PASS results Regulatory details: PRAC Rapporteur: Torbjörn Callreus (DK) Administrative details: Procedure number(s): EMEA/H/C/001211/MEA 015, EMEA/H/C/001114/MEA 017, EMEA/H/C/001210/MEA 015 Procedure scope: Fourth interim report for a PASS study QAB149B2432 of indacaterol prescribing and safety (using HealthCore database in the US) MAH(s): Novartis Europharm Ltd Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/257790/2015 Page 83/89
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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
Page 31 and 32: 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 67 and 68: Administrative details: Procedure n
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)
Page 75 and 76: 15.1.17. Influenza vaccine (split v
Page 77 and 78: 15.1.27. Pyronaridine, artesunate -
Page 79 and 80: 16.1.3. Sodium, magnesium, potassiu
Page 81: Administrative details: Procedure n
Page 85 and 86: 17. ANNEX I - Renewals of the Marke
Page 87 and 88: Name Role Member state or affiliati
Page 89: Name Role Member state or affiliati
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WC500185968

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