PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-000060-PIP04-14-M01
Compliance opinion date
Compliance outcome
Positive
Decision
P/0238/2015: EMA decision of 30 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for canakinumab (Ilaris), (EMEA-000060-PIP04-14-M01)
Public summary of the evaluation of a proposed product-specific waiver: Canakinumab for the treatment of familial Mediterranean fever (FMF) and treatment of hyperimmunoglobulin D syndrome