EMEA-000520-PIP01-08-M05 - paediatric investigation plan

belimumab

Key facts

• Invented name:
  • Benlysta
  • Benlysta
• Active substance:
  belimumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0183/2016
• PIP number:
  EMEA-000520-PIP01-08-M05
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Systemic Lupus Erythematosus (SLE)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/07/2016
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-000520-PIP01-08-M05
• Compliance opinion date:
  16/11/2018
• Compliance outcome:
  Positive

Decision

P/0183/2016: EMA decision of 15 July 2016 on the acceptance of a modification of an agreed paediatric investigation plan for belimumab (Benlysta) (EMEA-000520-PIP01-08-M05)

Adopted Reference Number: EMA/410886/2016