EMEA-001750-PIP01-15-M06 - paediatric investigation plan

rilpivirine

dolutegravir

Key facts

• Invented name:
  • Juluca
  • Juluca
• Active Substance:
  • rilpivirine
  • dolutegravir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0496/2022
• PIP number:
  EMEA-001750-PIP01-15-M06
• 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:
  02/12/2022

Decision

P/0496/2022 : EMA decision of 2 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for rilpivirine / dolutegravir (Juluca), (EMEA-001750-PIP01-15-M06)

AdoptedReference Number: EMA/852155/2022