EMEA-001465-PIP01-13-M05 - paediatric investigation plan

cobicistat

atazanavir (as sulfate)

Key facts

• Invented name:
  • Evotaz
  • Evotaz
• Active substance:
  • cobicistat
  • atazanavir (as sulfate)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0027/2023
• PIP number:
  EMEA-001465-PIP01-13-M05
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral solid dosage form
• 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:
  31/01/2023
• Compliance check done:
  No

Decision

P/0027/2023 : EMA decision of 31 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for atazanavir (sulphate) / cobicistat (Evotaz), (EMEA-001465-PIP01-13-M05)

Reference Number: EMA/21181/2023