EMEA-001625-PIP05-23 - paediatric investigation plan

satralizumab

Key facts

• Invented name:
  Enspryng
• Active substance:
  satralizumab
• Therapeutic area:
  Neurology
• Decision number:
  P/0298/2023
• PIP number:
  EMEA-001625-PIP05-23
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of thyroid eye disease
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/08/2023
• Compliance check done:
  No

Decision

P/0298/2023 : EMA decision of 11 August 2023 on the granting of a product specific waiver for satralizumab (Enspryng), (EMEA-001625-PIP05-23)

Reference Number: EMA/336539/2023