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Action: For adoption<br />
3.2. Initial applications; List of outstanding issues (Day 180; Day 120 for<br />
procedures with accelerated assessment timetable)<br />
3.2.1. - abaloparatide - EMEA/H/C/004157<br />
treatment of osteoporosis<br />
Scope: Day 180 list of outstanding issue<br />
Action: For adoption<br />
List of Questions adopted on 01.04.2016.<br />
3.2.2. - rurioctocog alfa pegol - EMEA/H/C/004195<br />
treatment of haemophilia A<br />
Scope: Day 180 list of outstanding issue<br />
Action: For adoption<br />
List of Questions adopted on 21.07.2016.<br />
Scope: List of Experts to ad-hoc expert group meeting, adopted by written procedure on<br />
28.11.2016.<br />
Action: For information<br />
3.2.3. - adalimumab - EMEA/H/C/004212<br />
treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis,<br />
psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn's<br />
disease, paediatri Crohn's disease and Ulcerative colitis<br />
Scope: Day 180 list of outstanding issue<br />
Action: For adoption<br />
List of Outstanding Issues adopted on 15.09.2016. List of Questions adopted on<br />
28.04.2016.<br />
3.2.4. - fluciclovine (18F) - EMEA/H/C/004197<br />
diagnostic agent for PET of adult men with suspected recurrence of prostate cancer<br />
Scope: Day 180 list of outstanding issue<br />
Action: For adoption<br />
List of Questions adopted on 28.04.2016.<br />
Committee for medicinal products for human use (CHMP)<br />
EMA/847927/2016 Page 10/39
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