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Scope: Start of procedure and appointment of Rapporteurs Article 13 triggered by the ANSM in France in January 2017 requesting the CHMP’s opinion whether the proposed lifting of the contraindication for a subset of anthracycline treated children is justified. Action: For adoption 11. Pharmacovigilance issue 11.1. Early Notification System February 2017 Early Notification System on envisaged CHMP/CMDh outcome accompanied by communication to the general public. Action: For information 12. Inspections 12.1. GMP inspections Disclosure of information related to GMP inspections will not be published as it undermines the purpose of such inspections 12.2. GCP inspections Disclosure of information related to GCP inspections will not be published as it undermines the purpose of such inspections 12.3. Pharmacovigilance inspections Disclosure of information related to Pharmacovigilance inspections will not be published as it undermines the purpose of such inspections 12.4. GLP inspections Disclosure of information related to GLP inspections will not be published as it undermines the purpose of such inspections 13. Innovation Task Force 13.1. Minutes of Innovation Task Force Action: For information Committee for medicinal products for human use (CHMP) EMA/CHMP/117089/2017 Page 30/39
13.2. Innovation Task Force briefing meetings Disclosure of information related to briefing meetings taking place with applicants cannot be released at present time as deemed to contain commercially confidential information Scope: ITF briefing meeting Meeting date: 27 February 2017 Action: For adoption Scope: ITF briefing meeting Meeting date: 13 March 2017 Action: For adoption 13.3. Requests for CHMP Opinion under Article 57(1)J and (1)P of Regulation (EC) No 726/2004 13.4. Nanomedicines activities 14. Organisational, regulatory and methodological matters 14.1. Mandate and organisation of the CHMP 14.1.1. CHMP meetings to be held in Valletta 28 February - 3 March 2017 under the Maltese Presidency of the Council of the European Union Scope: Information about the draft agenda topics of the upcoming Strategic Review and Learning meeting 28 February - 2 March 2017 Action: For discussion Scope: Information about the draft agenda topics of the upcoming meeting on - Making Article 58 and other European Medicines Agency outputs more relevant for non-EU regulators to be held in Valetta 2 March - 3 March 2017 Action: For discussion 14.1.2. Survey to committee members on the service provided by the Scientific Committees Service Scope: Findings of the survey to Committee Members Action: For information Committee for medicinal products for human use (CHMP) EMA/CHMP/117089/2017 Page 31/39
Page 1 and 2: 20 February 2017 EMA/CHMP/117089/20
Page 3 and 4: 3.2.11. - sarilumab - EMEA/H/C/0042
Page 5 and 6: 8.2.2. Recommendation for PRIME eli
Page 7 and 8: 14.3.12. Safety Working Party (SWP)
Page 9 and 10: 2.1.3. - pentosan polysulfate sodiu
Page 11 and 12: Scope: Opinion Action: For adoption
Page 13 and 14: 3.2.9. - febuxostat - EMEA/H/C/0043
Page 15 and 16: Scope: Day 120 list of questions Ac
Page 17 and 18: List of Questions adopted on 13.10.
Page 19 and 20: 4.3. Extension of marketing authori
Page 21 and 22: accordance. In addition, the Market
Page 23 and 24: Rapporteur: Greg Markey, Co-Rapport
Page 25 and 26: these contain commercially confiden
Page 27 and 28: An increased risk has not been seen
Page 29: 10.6. Community Interests - Referra
Page 33 and 34: 14.2.3. Committee for Herbal Medici
Page 35 and 36: 14.3.8. Rheumatology/Immunology Wor
Page 37 and 38: 16. Explanatory notes The notes bel
Page 39 and 40: particular medicine or class of med
Page 41 and 42: B.6.7. Type II Variations scope of
Page 43 and 44: MAH: Baxalta Innovations GmbH, Rapp
Page 45 and 46: MAH: Janssen-Cilag International NV
Page 47 and 48: amino acids and vitamins, acts as a
Page 49 and 50: EMEA/H/C/004137/II/0001 MAH: Zentiv
Page 51 and 52: MAH: Pfizer Limited, Rapporteur: Kr
Page 53 and 54: on 16.02.2017. BeneFIX - nonacog al
Page 55 and 56: local representatives in the Packag
Page 57 and 58: evise the instructions for handling
Page 59 and 60: subcutaneous doses of alirocumab on
Page 61 and 62: adverse drug reaction (hepatic enzy
Page 63 and 64: ALT due to treatment with the HCV c
Page 65 and 66: the implementation of the use of co
Page 67 and 68: Epclusa - sofosbuvir / velpatasvir
Page 69 and 70: Imbruvica - ibrutinib - EMEA/H/C/00
Page 71 and 72: TRYPHAENA study( BO22280) A randomi
Page 73 and 74: SmPC under the sub-heading 'Tabulat
Page 75 and 76: on 26.01.2017. Zykadia - ceritinib
Page 77 and 78: important identified risk.” Reque
Page 79 and 80: term Safety of Infliximab Study C01
Page 81 and 82:
MAH: Amgen Europe B.V., Rapporteur:
Page 83 and 84:
Rapporteur: Hanne Lomholt Larsen WS
Page 85 and 86:
EMEA/H/C/003825/WS1119/0007/G MAH:
Page 87 and 88:
Constella - linaclotide - EMEA/H/C/
Page 89 and 90:
The Package Leaflet and Risk Manage
Page 91 and 92:
B.6.8. CHMP assessed procedures sco
Page 93 and 94:
B.6.9. CHMP assessed procedures sco
Page 95 and 96:
Weight and Cardiovascular Risk Fact
Page 97 and 98:
Rapporteur: Hanne Lomholt Larsen, P
Page 99 and 100:
EMEA/H/C/004156/WS1133/0011/G Strib
Page 101 and 102:
in a type II variation (Procedure N
Page 103 and 104:
Exelon, Lead Rapporteur: Alexandre
Page 105:
G.3.1. List of procedures concludin
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