EMEA-002740-PIP01-19-M01 - paediatric investigation plan

lenacapavir sodium

Key facts

• Invented name:
  Sunlenca
• Active substance:
  lenacapavir sodium
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0271/2024
• PIP number:
  EMEA-002740-PIP01-19-M01
• Pharmaceutical form(s):
  • Age appropriate oral solid dosage form
  • Film-coated tablet
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  • Oral use
  • Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  19/07/2024
• Compliance check done:
  Nee

Decision

P/0271/2024: EMA decision of 19 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for lenacapavir sodium (Sunleca), (EMEA-002740-PIP01-19-M01)

Adopted Reference Number: EMA/307434/2024