EMEA-001577-PIP03-17 - paediatric investigation plan

emtricitabine

tenofovir alafenamide

Key facts

• Invented name:
  • Descovy
  • Descovy
• Active substance:
  • emtricitabine
  • tenofovir alafenamide
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0139/2018
• PIP number:
  EMEA-001577-PIP03-17
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Prevention of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  07/05/2018
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-001577-PIP03-17
• Compliance opinion date:
  20/09/2019
• Compliance outcome:
  Positive

Decision

P/0139/2018: EMA decision of 7 May 2018 on the agreement of a paediatric investigation plan and on the granting of a waiver for emtricitabine / tenofovir alafenamide (Descovy), (EMEA-001577-PIP03-17)

Adopted Reference Number: EMA/209254/2018