MEA-002958-PIP01-21 - paediatric investigation plan

Aficamten

Key facts

• Active Substance:
  Aficamten
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0023/2022
• PIP number:
  MEA-002958-PIP01-21
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of hypertrophic cardiomyopathy
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Cytokinetics, Inc.

  Tel.: [phone]; E-mail: [e-mail]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  31/01/2022

Decision

P/0023/2022 : EMA decision of 31 January 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for aficamten (EMEA-002958-PIP01-21)

AdoptedReference Number: EMA/8373/2022