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Action: For adoption 3.2. Initial applications; List of outstanding issues (Day 180; Day 120 for procedures with accelerated assessment timetable) 3.2.1. - abaloparatide - EMEA/H/C/004157 treatment of osteoporosis Scope: Day 180 list of outstanding issue Action: For adoption List of Questions adopted on 01.04.2016. 3.2.2. - rurioctocog alfa pegol - EMEA/H/C/004195 treatment of haemophilia A Scope: Day 180 list of outstanding issue Action: For adoption List of Questions adopted on 21.07.2016. Scope: List of Experts to ad-hoc expert group meeting, adopted by written procedure on 28.11.2016. Action: For information 3.2.3. - adalimumab - EMEA/H/C/004212 treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn's disease, paediatri Crohn's disease and Ulcerative colitis Scope: Day 180 list of outstanding issue Action: For adoption List of Outstanding Issues adopted on 15.09.2016. List of Questions adopted on 28.04.2016. 3.2.4. - fluciclovine (18F) - EMEA/H/C/004197 diagnostic agent for PET of adult men with suspected recurrence of prostate cancer Scope: Day 180 list of outstanding issue Action: For adoption List of Questions adopted on 28.04.2016. Committee for medicinal products for human use (CHMP) EMA/847927/2016 Page 10/39
3.2.5. - ivabradine - EMEA/H/C/004241 treatment of angina pectoris Scope: Day 180 list of outstanding issue Action: For adoption List of Questions adopted on 01.04.2016. 3.2.6. - pemetrexed - EMEA/H/C/004488 treatment of malignant pleural mesothelioma and non-small cell lung cancer Scope: Day 180 list of outstanding issue Action: For adoption List of Questions adopted on 21.07.2016. 3.2.7. - vosaroxin - Orphan - EMEA/H/C/004118 Sunesis Europe Ltd; treatment acute myeloid leukaemia Scope: Day 180 list of outstanding issue Action: For adoption List of Questions adopted on 28.04.2016. 3.2.8. - padeliporfin - EMEA/H/C/004182 treatment of prostate cancer Scope: Day 180 list of outstanding issue Action: For adoption List of Questions adopted on 26.05.2016. 3.2.9. - tofacitinib - EMEA/H/C/004214 treatment of active rheumatoid arthritis Scope: Day 180 list of outstanding issue Action: For adoption List of Questions adopted on 21.07.2016. 3.2.10. - human IgG1 monoclonal antibody specific for human interleukin-1 alpha - EMEA/H/C/004388 treatment of metastatic colorectal cancer Scope: Day 180 list of outstanding issue Action: For adoption Committee for medicinal products for human use (CHMP) EMA/847927/2016 Page 11/39
Page 1 and 2: 12 December 2016 EMA/847927/2016 In
Page 3 and 4: 3.3.4. - entecavir - EMEA/H/C/00445
Page 5 and 6: 8.2.2. Recommendation for PRIME eli
Page 7 and 8: 14.7. CHMP work plan ..............
Page 9: List of Outstanding Issues adopted
Page 13 and 14: 3.3.5. - entecavir - EMEA/H/C/00437
Page 15 and 16: 3.4.3. - ocrelizumab - EMEA/H/C/004
Page 17 and 18: 4.1.2. Tivicay - dolutegravir - EME
Page 19 and 20: neck, trunk and extremities in adul
Page 21 and 22: Rapporteur: Pierre Demolis, PRAC Ra
Page 23 and 24: 5.1.13. Zebinix - eslicarbazepine a
Page 25 and 26: Action: For adoption 8.2. Priority
Page 27 and 28: 10.2. Requests for CHMP Opinion und
Page 29 and 30: Regulatory Agency in United Kingdom
Page 31 and 32: 14. Organisational, regulatory and
Page 33 and 34: Action: For discussion Follow up fr
Page 35 and 36: PKWP Work plan 2017 (EMA/CHMP/64311
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.6.4. Annual Re-assessments: timet
Page 43 and 44: A. PRE SUBMISSION ISSUES A.1. ELIGI
Page 45 and 46: Caprelsa - vandetanib - EMEA/H/C/00
Page 47 and 48: CAPS: Imbruvica (EMEA/H/C/003791) (
Page 49 and 50: Applicant: MYLAN S.A.S, treatment o
Page 51 and 52: Opdivo - nivolumab - EMEA/H/C/00398
Page 53 and 54: EMEA/H/W/002495/WS0922/0059/G Hexyo
Page 55 and 56: EMEA/H/C/002735/II/0027/G MAH: Glax
Page 57 and 58: on 17.11.2016. Levemir - insulin de
Page 59 and 60: valent, adsorbed) - EMEA/H/C/001104
Page 61 and 62:
Lodewijk Hillege, “Update of sect
Page 63 and 64:
Relapsed or Refractory Indolent B-c
Page 65 and 66:
8.” Amyvid - florbetapir (18F) -
Page 67 and 68:
Epclusa - sofosbuvir / velpatasvir
Page 69 and 70:
PSUR 5 (PSUSA/00010128/201512); - c
Page 71 and 72:
In addition, the MAH takes the oppo
Page 73 and 74:
treatment, particularly in patients
Page 75 and 76:
is provided accordingly.” Request
Page 77 and 78:
add drug-drug interaction informati
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III randomised, double-blind, activ
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Inflectra.” PRAC Led Lyxumia - li
Page 83 and 84:
Zypadhera - olanzapine - EMEA/H/C/0
Page 85 and 86:
B.5.7. PRAC assessed ATMP procedure
Page 87 and 88:
B.5.9. Information on withdrawn typ
Page 89 and 90:
of giant cell arteritis for the sub
Page 91 and 92:
from the updated RMP version 18.”
Page 93 and 94:
EMEA/H/C/002569/WS1090/0014/G MAH:
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