EMEA-001825-PIP01-15-M05 - paediatric investigation plan

darunavir

cobicistat

emtricitabine

tenofovir alafenamide

Key facts

• Invented name:
  Symtuza
• Active substance:
  • darunavir
  • cobicistat
  • emtricitabine
  • tenofovir alafenamide
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0284/2024
• PIP number:
  EMEA-001825-PIP01-15-M05
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus type-1 (HIV-1) infection
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/08/2024
• Compliance check done:
  No

Decision

P/0284/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for darunavir / cobicistat / emtricitabine / tenofovir alafenamide (Symtuza), (EMEA-001825-PIP01-15-M05)

Adopted Reference Number: EMA/343666/2024