WC500185968

More documents

Recommendations

Info

Name Role Member state or via affiliation Outcome restriction following evaluation of e-DoI Topics on agenda for which restrictions apply telephone* Peter Volkers Expert - via telephone* Dörte Schwabe Expert - via telephone* Eleanor Carey Expert - in person* Anna Marie Coleman Expert - in person* Liana Gross-Martirosyan Expert - in person* Miroslava Matíková Expert - in person* Helena Möllby Expert - in person* Olle Karlström Expert - via telephone* Charlotte Backman Expert - in person* Filip Josephson Expert - via telephone* Juliana Min Expert - in person* Angelika Siapkara Expert - in person* Claire Davies Expert - in person* Jo Lyn Chooi Expert - in person* Claire Doe Expert - in person* Max Lagnado Expert - via telephone* Germany No interests declared Full involvement Germany No interests declared Full involvement Ireland No interests declared Full involvement Ireland No interests declared Full involvement Netherlands No interests declared Full involvement Slovakia No restrictions applicable to this meeting Full involvement Sweden No interests declared Full involvement Sweden No interests declared Full involvement Sweden No interests declared Full involvement Sweden No interests declared Full involvement United Kingdom No restrictions applicable to this meeting Full involvement United Kingdom No interests declared Full involvement United Kingdom No interests declared Full involvement United Kingdom No restrictions applicable to this meeting Full involvement United Kingdom No restrictions Full involvement applicable to this meeting United Kingdom No restrictions Full involvement applicable to this meeting Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/257790/2015 Page 88/89
Name Role Member state or affiliation Outcome restriction following evaluation of e-DoI Topics on agenda for which restrictions apply Andrew Ruddick Expert - via telephone* United Kingdom No restrictions applicable to this meeting A representative from the European Commission attended the meeting Meeting run with support from relevant EMA staff * Experts were only evaluated against the product(s) they have been invited to talk about. Full involvement Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/257790/2015 Page 89/89
Page 1 and 2:
10 April 2015 EMA/PRAC/257790/2015
Page 3 and 4:
Table of contents 1. Introduction .
Page 5 and 6:
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 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 83 and 84: MAH(s): Novartis Europharm Ltd 16.1
Page 85 and 86: 17. ANNEX I - Renewals of the Marke
Page 87: Name Role Member state or affiliati
show all

WC500185968

Create successful ePaper yourself

Delete template?

Save as template?