EMEA-002588-PIP01-19 - paediatric investigation plan

ritonavir

atazanavir (as sulfate)

Key facts

• Active substance:
  • ritonavir
  • atazanavir (as sulfate)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0396/2019
• PIP number:
  EMEA-002588-PIP01-19
• 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:
  04/12/2019
• Compliance check done:
  No

Decision

P/0396/2019: EMA decision of 4 December 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for atazanavir (sulfate) / ritonavir (EMEA-002588-PIP01-19)

Adopted Reference Number: EMA/623534/2019