EMEA-002681-PIP01-19-M02 - paediatric investigation plan

rozanolixizumab

Key facts

• Active substance:
  rozanolixizumab
• Therapeutic area:
  Neurology
• Decision number:
  P/0361/2023
• PIP number:
  EMEA-002681-PIP01-19-M02
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of myasthenia gravis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/09/2023
• Compliance check done:
  No

Decision

P/0361/2023: EMA decision of 8 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for rozanolixizumab (EMEA-002681-PIP01-19-M02)

Adopted