EMEA-002537-PIP02-19 - paediatric investigation plan

darunavir

ritonavir

Key facts

• Active substance:
  • darunavir
  • ritonavir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0308/2020
• PIP number:
  EMEA-002537-PIP02-19
• 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:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  12/08/2020
• Compliance check done:
  No

Decision

P/0308/2020 : EMA decision of 12 August 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for darunavir / ritonavir (EMEA-002537-PIP02-19)

Adopted Reference Number: EMA/388981/2020