PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-000339-PIP02-09-M03
Compliance opinion date
Compliance outcome
Positive
Decision
P/0125/2014: EMA decision of 16 May 2014 on the acceptance of a modification of an agreed paediatric investigation plan for entecavir (monohydrate) (Baraclude), (EMEA-000339-PIP02-09-M03)