EMEA-002756-PIP01-19-M01 - paediatric investigation plan

sotatercept

Key facts

• Active Substance:
  sotatercept
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0414/2022
• PIP number:
  EMEA-002756-PIP01-19-M01
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of pulmonary arterial hypertension
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Merck Sharp & Dohme B.V.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/09/2022

Decision

P/0414/2022 : EMA decision of 29 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for sotatercept (EMEA-002756-PIP01-19-M01)

AdoptedReference Number: EMA/777575/2022