Key facts

Invented name
  • Trelegy Ellipta
  • Temybric Ellipta
  • Elebrato Ellipta
Active Substance
  • fluticasone furoate
  • umeclidinium bromide
  • vilanterol trifenatate
Therapeutic area
Pneumology-allergology
Decision number
P/0058/2020
PIP number
EMEA-002153-PIP01-17-M01
Pharmaceutical form(s)
Inhalation powder (pre-dispensed)
Condition(s) / indication(s)
Treatment of asthma
Route(s) of administration
Inhalation use
Contact for public enquiries

GlaxoSmithKline Trading Services Limited

Tel. +1 438-899-8201
E-mail: eu.paediatric-plans@gsk.com

Decision type
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)

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