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List of Questions adopted on 21.07.2016.<br />
3.2.11. - adalimumab - EMEA/H/C/004373<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 />
3.3. Initial applications; List of questions (Day 120; Day 90 for procedures<br />
with accelerated assessment timetable)<br />
3.3.1. - cerliponase alfa - Orphan - EMEA/H/C/004065<br />
Accelerated assessment<br />
BioMarin International Limited; treatment of neuronal ceroid lipofuscinosis type 2<br />
Scope: Day 120 list of questions<br />
Action: For adoption<br />
3.3.2. - efavirenz / emtricitabine / tenofovir disoproxil - EMEA/H/C/004240<br />
treatment of HIV-1 infection<br />
Scope: Day 120 list of questions<br />
Action: For adoption<br />
3.3.3. - levamisole - Orphan - EMEA/H/C/004330<br />
ACE Pharmaceuticals BV; treatment of Steroid Sensitive Nephrotic syndrome<br />
Scope: Day 120 list of questions<br />
Action: For adoption<br />
3.3.4. - entecavir - EMEA/H/C/004458<br />
treatment of chronic hepatitis B virus infection<br />
Scope: Day 120 list of questions<br />
Action: For adoption<br />
Committee for medicinal products for human use (CHMP)<br />
EMA/847927/2016 Page 12/39
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