WC500185968

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15.1.2. Bosutinib – BOSULIF (CAP) Evaluation of a PSUSA procedure Regulatory details: PRAC Rapporteur: Martin Huber (DE) Administrative details: Procedure number(s): EMEA/H/C/002373/PSUSA/10073/201409 MAH(s): Pfizer Limited 15.1.3. Brentuximab vedotin – ADCETRIS (CAP) Evaluation of a PSUSA procedure Regulatory details: PRAC Rapporteur: Sabine Straus (NL) Administrative details: Procedure number(s): EMEA/H/C/002455/PSUSA/10039/201408 MAH(s): Takeda Pharma A/S 15.1.4. Cobicistat – TYBOST (CAP) Evaluation of a PSUSA procedure Regulatory details: PRAC Rapporteur: Rafe Suvarna (UK) Administrative details: Procedure number(s): EMEA/H/C/002572/PSUSA/10081/201408 MAH(s): Gilead Sciences International Ltd 15.1.5. Cobicistat, elvitegravir, emtricitabine, tenofovir disoproxil – STRIBILD (CAP) Evaluation of a PSUSA procedure Regulatory details: PRAC Rapporteur: Rafe Suvarna (UK) Administrative details: Procedure number(s): EMEA/H/C/002574/PSUSA/10082/201408 MAH(s): Gilead Sciences International Ltd 15.1.6. Crizotinib – XALKORI (CAP) Evaluation of a PSUSA procedure Regulatory details: PRAC Rapporteur: Arnaud Batz (FR) Administrative details: Procedure number(s): EMEA/H/C/002489/PSUSA/10042/201408 MAH(s): Pfizer Limited Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/257790/2015 Page 72/89
15.1.7. Dabrafenib – TAFINLAR (CAP) Evaluation of a PSUSA procedure Regulatory details: PRAC Rapporteur: Ulla Wändel Liminga (SE) Administrative details: Procedure number(s): EMEA/H/C/002604/PSUSA/10084/201408 MAH(s): GlaxoSmithKline Trading Services 15.1.8. Deferiprone – FERRIPROX (CAP) Evaluation of a PSUSA procedure Regulatory details: PRAC Rapporteur: Arnaud Batz (FR) Administrative details: Procedure number(s): EMEA/H/C/000236/PSUSA/00940/201408 MAH(s): Apotex Europe BV 15.1.9. Dexmedetomidine – DEXDOR (CAP) Evaluation of a PSUSA procedure Regulatory details: PRAC Rapporteur: Julie Williams (UK) Administrative details: Procedure number(s): EMEA/H/C/002268/PSUSA/00998/201409 MAH(s): Orion Corporation 15.1.10. Elosulfase alfa – VIMIZIM (CAP) Evaluation of a PSUSA procedure Regulatory details: PRAC Rapporteur: Julie Williams (UK) Administrative details: Procedure number(s): EMEA/H/C/002779/PSUSA/10218/201408 MAH(s): BioMarin Europe Ltd 15.1.11. Elvitegravir – VITEKTA (CAP) Evaluation of a PSUSA procedure Regulatory details: PRAC Rapporteur: Rafe Suvarna (UK) Administrative details: Procedure number(s): EMEA/H/C/002577/PSUSA/02577/201408 MAH(s): Gilead Sciences International Ltd Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/257790/2015 Page 73/89
Page 1 and 2:
10 April 2015 EMA/PRAC/257790/2015
Page 3 and 4:
Table of contents 1. Introduction .
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6.2. Follow-up to PSUR procedures .
Page 7 and 8:
12.15. Contacts of the PRAC with ex
Page 9 and 10:
15.1.25. Pandemic influenza vaccine
Page 11 and 12:
1. Introduction 1.1. Welcome and de
Page 13 and 14:
Regulatory details: PRAC Rapporteur
Page 15 and 16:
mainly reported in the published li
Page 17 and 18:
During routine signal detection act
Page 19 and 20:
Taking into account this first repo
Page 21 and 22: During routine signal detection act
Page 23 and 24: Summary of recommendation(s) The M
Page 25 and 26: 4.3.5. Sodium containing formulatio
Page 27 and 28: Intended indication(s): Treatment i
Page 29 and 30: 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 69 and 70: Procedure scope: Extension of indic
Page 71: Procedure scope: Grouped variation
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 83 and 84: MAH(s): Novartis Europharm Ltd 16.1
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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