EMEA-001577-PIP02-14-M05 - paediatric investigation plan

emtricitabine

tenofovir alafenamide

Key facts

• Invented name:
  • Descovy
  • Descovy
• Active Substance:
  • emtricitabine
  • tenofovir alafenamide
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0402/2022
• PIP number:
  EMEA-001577-PIP02-14-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
• Contact for public enquiries:

  Gilead Sciences International Ltd

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/09/2022

Decision

P/0402/2022 : EMA decision of 9 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for emtricitabine / tenofovir alafenamide (Descovy), (EMEA-001577-PIP02-14-M05)

AdoptedReference Number: EMA/709116/2022