P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date
Decision
P/0104/2018: EMA decision of 11 April 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for obeticholic acid (Ocaliva), (EMEA-001304-PIP03-17)