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List of Outstanding Issues adopted on 15.09.2016, 21.07.2016, 28.04.2016, 24.09.2015. List of Questions adopted on 26.03.2015. BWP report 3.1.4. - pemetrexed - EMEA/H/C/004488 treatment of malignant pleural mesothelioma and non-small cell lung cancer Scope: Opinion Action: For adoption List of Outstanding Issues adopted on 15.12.2016. List of Questions adopted on 21.07.2016. 3.1.5. - rituximab - EMEA/H/C/003903 treatment of Non-Hodgkin's lymphoma (NHL), Chronic lymphocytic leukaemia (CLL), Rheumatoid arthritis and Granulomatosis with polyangiitis and microscopic polyangiitis Scope: Opinion Action: For adoption List of Questions adopted on 15.09.2016. BWP report 3.1.6. - edoxaban - EMEA/H/C/004339 prevention of stroke; embolism and treatment of venous thromboembolism Scope: Opinion Action: For adoption 3.1.7. - rolapitant - EMEA/H/C/004196 prevention of nausea and vomiting Scope: Opinion Action: For adoption List of Outstanding Issues adopted on 10.11.2016. List of Questions adopted on 21.07.2016. 3.1.8. - rituximab - EMEA/H/C/004729 treatment of Non-Hodgkin's lymphoma (NHL), Chronic lymphocytic leukaemia (CLL), Rheumatoid arthritis and Granulomatosis with polyangiitis and microscopic polyangiitis Committee for medicinal products for human use (CHMP) EMA/CHMP/117089/2017 Page 10/39
Scope: Opinion Action: For adoption 3.2. Initial applications; List of outstanding issues (Day 180; Day 120 for procedures with accelerated assessment timetable) 3.2.1. - anamorelin - EMEA/H/C/003847 treatment of anorexia, cachexia or unintended weight loss in adult patients with non-small cell lung cancer (NSCLC) Scope: Day 180 list of outstanding issue Action: For adoption List of Outstanding Issues adopted on 10.11.2016. List of Questions adopted on 25.02.2016. 3.2.2. - expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue - Orphan - ATMP - EMEA/H/C/004258 TIGENIX, S.A.U.; treatment of complex perianal fistula(s) Scope: Day 180 list of outstanding issue Action: For adoption List of Questions adopted on 15.07.2016. BWP report 3.2.3. - inotuzumab ozogamicin - Orphan - EMEA/H/C/004119 Pfizer Limited; treatment B-cell precursor acute lymphoblastic leukaemia (ALL) Scope: Day 180 list of outstanding issue Action: For adoption List of Questions adopted on 15.09.2016. BWP report 3.2.4. - cerliponase alfa - Orphan - EMEA/H/C/004065 Accelerated assessment BioMarin International Limited; treatment of neuronal ceroid lipofuscinosis type 2 Scope: Day 180 list of outstanding issue, list of experts for the Brineura ad hoc expert group meeting adopted via written procedure Committee for medicinal products for human use (CHMP) EMA/CHMP/117089/2017 Page 11/39
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: 2.1.3. - pentosan polysulfate sodiu
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 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
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ALT due to treatment with the HCV c
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the implementation of the use of co
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Epclusa - sofosbuvir / velpatasvir
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Imbruvica - ibrutinib - EMEA/H/C/00
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TRYPHAENA study( BO22280) A randomi
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SmPC under the sub-heading 'Tabulat
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on 26.01.2017. Zykadia - ceritinib
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important identified risk.” Reque
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term Safety of Infliximab Study C01
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MAH: Amgen Europe B.V., Rapporteur:
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Rapporteur: Hanne Lomholt Larsen WS
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EMEA/H/C/003825/WS1119/0007/G MAH:
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Constella - linaclotide - EMEA/H/C/
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The Package Leaflet and Risk Manage
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B.6.8. CHMP assessed procedures sco
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B.6.9. CHMP assessed procedures sco
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Weight and Cardiovascular Risk Fact
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Rapporteur: Hanne Lomholt Larsen, P
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EMEA/H/C/004156/WS1133/0011/G Strib
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in a type II variation (Procedure N
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Exelon, Lead Rapporteur: Alexandre
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G.3.1. List of procedures concludin
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