P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date
Compliance check done
No
Decision
P/0201/2016: EMA decision of 28 July 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for eculizumab (Soliris), (EMEA-000876-PIP06-15)