EMEA-002974-PIP01-21 - paediatric investigation plan

Benzylamine derivative of benzofuran (BCX9930)

Key facts

• Active Substance:
  Benzylamine derivative of benzofuran (BCX9930)
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0125/2022
• PIP number:
  EMEA-002974-PIP01-21
• Pharmaceutical form(s):
  • Age-appropriate oral solid dosage form
  • Tablet
• 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:
  15/04/2022

Decision

P/0125/2022 : EMA decision of 15 April 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for benzylamine derivative of benzofuran (BCX9930) (EMEA-002974-PIP01-21)

AdoptedReference Number: EMA/149065/2022