EMEA-003324-PIP01-22 - paediatric investigation plan

bictegravir

lenacapavir

Key facts

• Active substance:
  • bictegravir
  • lenacapavir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0265/2023
• PIP number:
  EMEA-003324-PIP01-22
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral solid dosage form
• 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:
  14/07/2023
• Compliance check done:
  No

Decision

P/0265/2023 : EMA decision of 14 July 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for bictegravir / lenacapavir (EMEA-003324-PIP01-22)

Reference Number: EMA/284569/2023