WC500185968

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15.1.12. Fenofibrate, simvastatin – CHOLIB (CAP) Evaluation of a PSUSA procedure Regulatory details: PRAC Rapporteur: Julie Williams (UK) Administrative details: Procedure number(s): EMEA/H/C/002559/PSUSA/10096/201408 MAH(s): Abbott Healthcare Products Ltd. 15.1.13. Florbetaben ( 18 F) – NEURACEQ (CAP) Evaluation of a PSUSA procedure Regulatory details: PRAC Rapporteur: Julie Williams (UK) Administrative details: Procedure number(s): EMEA/H/C/002553/PSUSA/10094/201408 MAH(s): Piramal Imaging Limited 15.1.14. Pioglitazone - ACTOS (CAP), GLUSTIN (CAP), NAP pioglitazone, glimepiride - TANDEMACT (CAP) pioglitazone, metformin – COMPETACT (CAP), GLUBRAVA (CAP) Evaluation of a PSUSA procedure Regulatory details: PRAC Rapporteur: Almath Spooner (IE) Administrative details: Procedure number(s): EMEA/H/C/000285/PSUSA/02417/201407, EMEA/H/C/000655/PSUSA/02417/201407, EMEA/H/C/000893/PSUSA/02417/201407, EMEA/H/C/000286/PSUSA/02417/201407, EMEA/H/C/000680/PSUSA/02417/201407 MAH(s): Takeda Pharma A/S 15.1.15. Human coagulation factor VIII, human von willebrand factor – VONCENTO (CAP) Evaluation of a PSUSA procedure Regulatory details: PRAC Rapporteur: Sabine Straus (NL) Administrative details: Procedure number(s): EMEA/H/C/002493/PSUSA/10102/201408 MAH(s): CSL Behring GmbH 15.1.16. Ibuprofen – PEDEA (CAP) Evaluation of a PSUSA procedure Regulatory details: PRAC Rapporteur: Almath Spooner (IE) Administrative details: Procedure number(s): EMEA/H/C/000549/PSUSA/01712/201407 MAH(s): Orphan Europe S.A.R.L. Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/257790/2015 Page 74/89
15.1.17. Influenza vaccine (split virion, inactivated) – IDFLU (CAP), INTANZA (CAP) Evaluation of a PSUSA procedure Regulatory details: PRAC Rapporteur: Miguel-Angel Macia (ES) Administrative details: Procedure number(s): EMEA/H/C/000966/PSUSA/01743/201408, EMEA/H/C/000957/PSUSA/01743/201408 MAH(s): Sanofi Pasteur 15.1.18. Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) – OPTAFLU (CAP) Evaluation of a PSUSA procedure Regulatory details: PRAC Rapporteur: Menno van der Elst (NL) Administrative details: Procedure number(s): EMEA/H/C/000758/PSUSA/01745/201408 MAH(s): Novartis Vaccines and Diagnostics GmbH 15.1.19. Linaclotide – CONSTELLA (CAP) Evaluation of a PSUSA procedure Regulatory details: PRAC Rapporteur: Valerie Strassmann (DE) Administrative details: Procedure number(s): EMEA/H/C/002490/PSUSA/10025/201408 MAH(s): Almirall S.A 15.1.20. Loxapine – ADASUVE (CAP) Evaluation of a PSUSA procedure Regulatory details: PRAC Rapporteur: Sabine Straus (NL) Administrative details: Procedure number(s): EMEA/H/C/002400/PSUSA/10113/201408 MAH(s): Alexza UK Ltd. 15.1.21. Midazolam – BUCCOLAM (CAP) Evaluation of a PSUSA procedure Regulatory details: PRAC Rapporteur: Sabine Straus (NL) Administrative details: Procedure number(s): EMEA/H/C/002267/PSUSA/10118/201409 MAH(s): ViroPharma SPRL Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/257790/2015 Page 75/89
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 .
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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
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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 and 72: Procedure scope: Grouped variation
Page 73: 15.1.7. Dabrafenib - TAFINLAR (CAP)
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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