RPM: decision refers to a refusal on the application for modification of an agreed PIP
Decision date
Decision
P/0058/2020: EMA decision of 14 February 2020 on the refusal of a modification of an agreed paediatric investigation plan for fluticasone furoate / umeclidinium bromide / vilanterol trifenatate (Trelegy Ellipta / Elebrato Ellipta / Temybric Ellipta)
Fluticasone furoate, vilanterol trifenatate and umeclidinium bromide - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision