EMA/PE/0000232781 - paediatric investigation plan

lenacapavir sodium / islatravir

Key facts

• Active substance:
  lenacapavir sodium / islatravir
• Therapeutic area:
  Infections and infestations
• Decision number:
  EMA/PE/0000232781
• PIP number:
  EMA/PE/0000232781
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate formulation
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus type 1 (HIV-1) infection
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  20/03/2025
• Compliance check done:
  No

Decision

EMA/PE/0000232781 : EMA decision of 20 March 2025 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 / islatravir

Adopted Reference Number: EMADOC-1700519818-1976549