EMEA-001825-PIP01-15-M04 - paediatric investigation plan

darunavir

cobicistat

emtricitabine

tenofovir alafenamide

Key facts

• Invented name:
  Symtuza
• Active Substance:
  • darunavir
  • cobicistat
  • emtricitabine
  • tenofovir alafenamide
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0029/2023
• PIP number:
  EMEA-001825-PIP01-15-M04
• 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
• Contact for public enquiries:

  Janssen-Cilag International NV

  Tel. + 32 1460 2111; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/01/2023

Decision

P/0029/2023 : EMA decision of 31 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for darunavir / cobicistat / emtricitabine / tenofovir alafenamide (Symtuza), (EMEA-001825-PIP01-15-M04)

Reference Number: EMA/21182/2023