EMEA-001766-PIP01-15-M05 - paediatric investigation plan

bictegravir

emtricitabine

tenofovir alafenamide

Key facts

• Invented name:
  Biktarvy
• Active substance:
  • bictegravir
  • emtricitabine
  • tenofovir alafenamide
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0242/2023
• PIP number:
  EMEA-001766-PIP01-15-M05
• 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:
  14/06/2023
• Compliance check done:
  No

Decision

P/0242/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for bictegravir / emtricitabine / tenofovir alafenamide (Biktarvy), (EMEA-001766-PIP01-15-M05)

Reference Number: EMA/250921/2023