EMEA-001976-PIP02-18 - paediatric investigation plan

3-[5-[(1R,2S)-2-(2,2-difluoropropanoylamino)-1-(2,3-dihydro-1,4-benzodioxin-6-yl)propoxy]indazol-1- yl]-N-[(3R)-tetrahydrofuran-3-yl]benzamide (AZD7594)

Key facts

• Active Substance:
  3-[5-[(1R,2S)-2-(2,2-difluoropropanoylamino)-1-(2,3-dihydro-1,4-benzodioxin-6-yl)propoxy]indazol-1- yl]-N-[(3R)-tetrahydrofuran-3-yl]benzamide (AZD7594)
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0402/2019
• PIP number:
  EMEA-001976-PIP02-18
• Pharmaceutical form(s):
  • Inhalation powder
  • Nebuliser suspension
  • Pressurised inhalation suspension
• Condition(s) / indication(s):
  Treatment of asthma
• Route(s) of administration:
  Inhalation use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  20/12/2019

Decision

P/0402/2019: EMA decision of 20 December 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 3-[5-[(1R,2S)-2-(2,2-difluoropropanoylamino)-1-(2,3-dihydro-1,4- benzodioxin-6-yl)...

AdoptedReference Number: EMA/629978/2019