EMEA-000317-PIP01-08-M13 - paediatric investigation plan

rilpivirine hydrochloride

Key facts

• Invented name:
  Edurant
• Active substance:
  rilpivirine hydrochloride
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0101/2022
• PIP number:
  EMEA-000317-PIP01-08-M13
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate solid oral formulation
• 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:
  12/08/2020
• Compliance check done:
  Jah
• Compliance procedure number:
  EMEA-C-000317-PIP01-08-M13
• Compliance opinion date:
  23/06/2023
• Compliance outcome:
  Positive

Decision

P/0101/2022 : EMA decision of 17 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for rilpivirine (hydrochloride) (Edurant), (EMEA-000317-PIP01-08-M13)

Adopted Reference Number: EMA/145471/2022 Corr1