EMEA-001750-PIP01-15-M07 - paediatric investigation plan

rilpivirine

dolutegravir

Key facts

• Invented name:
  Juluca
• Active substance:
  • rilpivirine
  • dolutegravir
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0283/2024
• PIP number:
  EMEA-001750-PIP01-15-M07
• 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:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/08/2024
• Compliance check done:
  No

Decision

P/0283/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for rilpivirine / dolutegravir (Juluca), (EMEA-001750-PIP01-15-M07)

Adopted Reference Number: EMA/343368/2024