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Flebogamma DIF - human normal immunoglobulin - EMEA/H/C/000781/R/0048 MAH: Instituto Grifols, S.A., Rapporteur: Jan Mueller-Berghaus, Co-Rapporteur: Concepcion Prieto Yerro, PRAC Rapporteur: Brigitte Keller- Stanislawski Increlex - mecasermin - EMEA/H/C/000704/R/0042, Orphan MAH: Ipsen Pharma, Rapporteur: Outi Mäki- Ikola, Co-Rapporteur: Agnes Gyurasics, PRAC Rapporteur: Kirsti Villikka Jakavi - ruxolitinib - EMEA/H/C/002464/R/0032 MAH: Novartis Europharm Ltd, Rapporteur: Filip Josephson, Co-Rapporteur: Robert James Hemmings, PRAC Rapporteur: Ulla Wändel Liminga Pergoveris - follitropin alfa / lutropin alfa - EMEA/H/C/000714/R/0050 MAH: Merck Serono Europe Limited, Rapporteur: Nithyanandan Nagercoil, Co- Rapporteur: Hanne Lomholt Larsen, PRAC Rapporteur: Julie Williams Request for Supplementary Information adopted on 15.12.2016. Rasilez - aliskiren - EMEA/H/C/000780/R/0112 MAH: Novartis Europharm Ltd, Rapporteur: Daniela Melchiorri, Co-Rapporteur: Melinda Sobor, PRAC Rapporteur: Carmela Macchiarulo Zinforo - ceftaroline fosamil - EMEA/H/C/002252/R/0031 MAH: AstraZeneca AB, Rapporteur: Greg Markey, Co-Rapporteur: Alar Irs, PRAC Rapporteur: Julie Williams Zoledronic acid medac - zoledronic acid - EMEA/H/C/002359/R/0018 MAH: medac Gesellschaft fur klinische Spezialpraparate mbH, Generic, Generic of Zometa, Rapporteur: Alar Irs, PRAC Rapporteur: Doris Stenver B.2.3. Renewals of Conditional Marketing Authorisations Darzalex - daratumumab - EMEA/H/C/004077/R/0003, Orphan Annex to February 2017 CHMP Agenda EMA/CHMP/117606/2017 Page 5/66
MAH: Janssen-Cilag International NV, Rapporteur: Sinan B. Sarac, PRAC Rapporteur: Marcia Sofia Sanches de Castro Lopes Silva Pandemic influenza vaccine H5N1 MedImmune - pandemic influenza vaccine (H5N1) (live attenuated, nasal) - EMEA/H/C/003963/R/0003 MAH: MedImmune LLC, Rapporteur: Jan Mueller-Berghaus, PRAC Rapporteur: Jan Neuhauser B.3. POST-AUTHORISATION PHARMACOVIGILANCE OUTCOMES Signal detection PRAC recommendations on signals adopted at the PRAC meeting held on on 06-09 February 2017: Opdivo (EMEA/H/C/003985) (Nivolumab), MAH: Bristol-Myers Squibb Pharma EEIG, Rapporteur: Aranzazu Sancho-Lopez, Co- Rapporteur: Paula Boudewina van Hennik, EPL: Silvy Da Rocha Dias, Signal of pemphigoid: For adoption PSUR procedures for which PRAC adopted a recommendation for variation of the terms of the MA at its February 2017 meeting: EMEA/H/C/PSUSA/00002665/201607 (rotavirus vaccine monovalent (live, oral)) CAPS: Rotarix (EMEA/H/C/000639) (human rotavirus, live attenuated), MAH: GlaxoSmithKline Biologicals S.A., Rapporteur: Bart Van der Schueren, PRAC Rapporteur: Jean-Michel Dogné, “12.07.2015-11.07.2016” EMEA/H/C/PSUSA/00010035/201607 (ingenol mebutate) CAPS: Picato (EMEA/H/C/002275) (ingenol mebutate), MAH: LEO Laboratories Ltd, Rapporteur: Nithyanandan Nagercoil, PRAC Rapporteur: Julie Williams, “1 February 2016 to 31 July 2016 – DLP 31 July 2016.” EMEA/H/C/PSUSA/00010404/201607 (atazanavir / cobicistat) CAPS: EVOTAZ (EMEA/H/C/003904) (atazanavir / cobicistat), MAH: Bristol-Myers Squibb Pharma Annex to February 2017 CHMP Agenda EMA/CHMP/117606/2017 Page 6/66
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 and 30: 10.6. Community Interests - Referra
Page 31 and 32: 13.2. Innovation Task Force briefin
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: MAH: Baxalta Innovations GmbH, Rapp
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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