EMEA-002709-PIP01-19-M01 - paediatric investigation plan

Crovalimab

Key facts

• Active Substance:
  Crovalimab
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0056/2023
• PIP number:
  EMEA-002709-PIP01-19-M01
• Pharmaceutical form(s):
  Solution for injection/infusion
• Condition(s) / indication(s):
  • Treatment of atypical haemolytic uremic syndrome
  • Treatment of paroxysmal nocturnal haemoglobinuria
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Contact for public enquiries:

  Roche Registration GmbH

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/01/2023
• Compliance opinion date:
  20/09/2019
• Compliance outcome:
  Positive

Decision

P/0056/2023: EMA decision of 30 January 2023 the acceptance of a modification of an agreed paediatric investigation plan for crovalimab (EMEA002709-PIP01-19-M01)

Reference Number: EMA//21389/2023