PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-000425-PIP02-10-M04
Compliance opinion date
Compliance outcome
Positive
Decision
P/0090/2013: EMA decision of 29 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for bosentan (Tracleer) (EMEA-000425-PIP02-10-M04)