Key facts

Active Substance
2-[[2-ethyl-6-[4-[2-(3-hydroxyazetidin-1-yl)-2-oxoethyl]piperazin-1-yl]-8-methylimidazo[1,2-a]pyridin-3-yl](methyl)amino]-4-(4-fluorophenyl)-1,3-thiazole-5-carbonitrile
Therapeutic area
Pneumology-allergology
Decision number
P/0148/2020
PIP number
EMEA-002333-PIP02-19
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate formulation
Condition(s) / indication(s)
Treatment of interstitial pulmonary diseases with fibrosis
Route(s) of administration
Oral use
Contact for public enquiries

Galapagos NV

Tel. +32 15342900
E-mail: medicalinfo@glpg.com

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date

Decision

P/0148/2020: EMA decision of 18 April 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 2-[[2-ethyl-6-[4-[2-(3-hydroxyazetidin-1-yl)-2-oxoethyl]piperazin-1-yl]...

How useful do you find this page?