EMEA-000520-PIP02-13-M04 - paediatric investigation plan

belimumab

Key facts

• Invented name:
  Benlysta
• Active Substance:
  belimumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0395/2022
• PIP number:
  EMEA-000520-PIP02-13-M04
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of Systemic Lupus Erythematosus (SLE)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/09/2022
• Compliance procedure number:
  EMEA-C-000520-PIP02-13-M04
• Compliance opinion date:
  15/12/2023
• Compliance outcome:
  Positive

Decision

P/0395/2022 : EMA decision of 9September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for belimumab (Benlysta), (EMEA-000520-PIP02-13-M04)

AdoptedReference Number: P/0395/2022