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Action: For adoption<br />
List of Questions adopted on 13.12.2016.<br />
3.2.5. - spheroids of human autologous matrix-associated chondrocytes - ATMP -<br />
EMEA/H/C/002736<br />
treatment of cartilage defects<br />
Scope: Day 180 list of outstanding issue<br />
Action: For adoption<br />
List of Questions adopted on 19.04.2013.<br />
BWP report<br />
3.2.6. trientine tetrahydrochloride - Orphan - EMEA/H/C/004005<br />
GMP-Orphan SA; Wilson’s disease<br />
Scope: Day 180 list of outstanding issue/Oral Explanation<br />
Action: For adoption<br />
List of Outstanding Issues adopted on 13.10.2016. List of Questions adopted on<br />
28.04.2016.<br />
3.2.7. - etanercept - EMEA/H/C/004192<br />
treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial<br />
spondyloarthritis, ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis,<br />
plaque psoriasis and paediatric plaque psoriasis<br />
Scope: Day 180 list of outstanding issue<br />
Action: For adoption<br />
List of Questions adopted on 01.04.2016.<br />
BWP report<br />
3.2.8. - iloperidone - EMEA/H/C/004149<br />
treatment of schizophrenia<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/CHMP/117089/2017 Page 12/39
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