EMA/PE/0000240971 - paediatric investigation plan

rilpivirine hydrochloride

dolutegravir sodium

Key facts

• Invented name:
  Juluca
• Active substance:
  • rilpivirine hydrochloride
  • dolutegravir sodium
• Therapeutic area:
  Infections and infestations
• Decision number:
  EMA/PE/0000240971
• PIP number:
  EMA/PE/0000240971
• 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:
  16/05/2025
• Compliance check done:
  Nei

Decision

EMA/PE/0000240971 : EMA decision of 16 May 2025 on the acceptance of a modification of an agreed paediatric investigation plan for rilpivirine / dolutegravir (Juluca)

Adopted Reference Number: EMADOC-1700519818-2107377