EMEA-002231-PIP01-17-M01 - paediatric investigation plan

Mavacamten

Key facts

• Invented name:
  Camzyos
• Active Substance:
  Mavacamten
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0278/2023
• PIP number:
  EMEA-002231-PIP01-17-M01
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Treatment of hypertrophic cardiomyopathy
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Bristol-Myers Squibb Pharma EEIG

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/07/2023

Decision

P/0278/2023 : EMA decision of 14 July 2023 on the acceptance of a modification of an agreed paediatric investigation plan for mavacamten (EMEA- 002231-PIP01-17-M01)

Reference Number: EMA/283075/2023