EMEA-002740-PIP03-24 - paediatric investigation plan

lenacapavir sodium

Key facts

• Invented name:
  Sunlenca
• Active substance:
  lenacapavir sodium
• Decision number:
  P/0372/2024
• PIP number:
  EMEA-002740-PIP03-24
• Pharmaceutical form(s):
  • Concentrate for solution for injection
  • Film-coated tablet
  • Age-appropriate oral and/or subcutaneous dosage form
• Condition(s) / indication(s):
  Prevention of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  • Subcutaneous use
  • Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  25/10/2024
• Compliance check done:
  Nej

Decision

P/0372/2024: EMA decision of of 25 October 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for lenacapavir sodium (Sunleca), (EMEA-002740-PIP03-24)

Reference Number: EMA/483453/2024