EMEA-002863-PIP01-20 - paediatric investigation plan

(1R,3S,5R)-2-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromo-3- methylpyridin-2-yl)-5-methyl-2-azabicyclo[3.1.0]hexane-3-carboxamide (ALXN2050)

Key facts

• Active substance:
  (1R,3S,5R)-2-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromo-3- methylpyridin-2-yl)-5-methyl-2-azabicyclo[3.1.0]hexane-3-carboxamide (ALXN2050)
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0324/2021
• PIP number:
  EMEA-002863-PIP01-20
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of paroxysmal nocturnal haemoglobinuria
• 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:
  11/08/2021
• Compliance check done:
  No

Decision

P/0324/2021 : EMA decision of 11 August 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (1R,3S,5R)-2-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl).....(EMEA-002863-PIP01-20)

Adopted Reference Number: EMA/418664/2021