EMEA-000317-PIP02-18-M01 - paediatric investigation plan

rilpivirine

Key facts

• Invented name:
  Rekambys
• Active substance:
  rilpivirine
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0397/2022
• PIP number:
  EMEA-000317-PIP02-18-M01
• Pharmaceutical form(s):
  Prolonged release suspension for injection
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/09/2022
• Compliance check done:
  Nej

Decision

P/0397/2022 : EMA decision of 9 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for rilpivirine (Rekambys), (EMEA-000317-PIP02-18-M01)

Adopted Reference Number: EMA/709307/2022