PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-000145-PIP01-07-M09
Compliance opinion date
Compliance outcome
Positive
Decision
P/0098/2018: EMA decision of 16 March 2018 on the acceptance of a modification of an agreed paediatric investigation plan for denosumab (Xgeva, Prolia), (EMEA-000145-PIP01-07-M09)