EMEA-003237-PIP01-22 - paediatric investigation plan

Cemdisiran

Key facts

• Active Substance:
  Cemdisiran
• Therapeutic area:
  Neurology
• Decision number:
  P/0065/2023
• PIP number:
  EMEA-003237-PIP01-22
• Pharmaceutical form(s):
  Concentrate for solution for injection
• Condition(s) / indication(s):
  Treatment of myasthenia gravis
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Regeneron Ireland DAC

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/03/2023

Decision

P/0065/2023 : EMA decision of 10 March 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for cemdisiran (EMEA-003237-PIP01-22)

AdoptedReference Number: EMA/84291/2023