EMEA-002333-PIP02-19 - paediatric investigation plan

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

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
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  18/04/2020

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]...

AdoptedReference Number: EMA/174870/2020