EMEA-001460-PIP01-13-M05 - paediatric investigation plan

elvitegravir

cobicistat

emtricitabine

tenofovir alafenamide

Key facts

• Invented name:
  Genvoya
• Active substance:
  • elvitegravir
  • cobicistat
  • emtricitabine
  • tenofovir alafenamide
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0435/2020
• PIP number:
  EMEA-001460-PIP01-13-M05
• Pharmaceutical form(s):
  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:
  13/11/2020
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001460-PIP01-13-M05
• Compliance opinion date:
  25/06/2021
• Compliance outcome:
  Positive

Decision

P/0435/2020 : EMA decision of 13 November 2020 on the acceptance of a modification of an agreed paediatric investigation plan for elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide (Genvoya) (EMEA-001460-PIP01-13-M05)

Adopted Reference Number: EMA/593114/2020