EMEA-000520-PIP03-23 - paediatric investigation plan

belimumab

Key facts

• Invented name:
  Benlysta
• Active substance:
  belimumab
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  P/0109/2024
• PIP number:
  EMEA-000520-PIP03-23
• Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of systemic sclerosis
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  12/04/2024
• Compliance check done:
  No

Decision

P/0109/2024: EMA decision on 12 April 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for belimumab (Benlysta), (EMEA-000520-PIP03-23)

Adopted Reference Number: EMA/105425/2024