EMA/PE/0000226217 - paediatric investigation plan

bictegravir

emtricitabine

tenofovir alafenamide

Key facts

• Invented name:
  Biktarvy
• Active substance:
  • bictegravir
  • emtricitabine
  • tenofovir alafenamide
• Therapeutic area:
  Infectious diseases
• Decision number:
  EMA/PE/0000226217
• PIP number:
  EMA/PE/0000226217
• Pharmaceutical form(s):
  • Age appropriate oral formulation
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/01/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000226217 : EMA decision of 28 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for bictegravir / emtricitabine / tenofovir alafenamide (Biktarvy)

Adopted Reference Number: EMADOC-1700519818-1860349