EMEA-001940-PIP01-16-M06 - paediatric investigation plan

lamivudine

dolutegravir

Key facts

• Invented name:
  Dovato
• Active substance:
  • lamivudine
  • dolutegravir
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0243/2024
• PIP number:
  EMEA-001940-PIP01-16-M06
• Pharmaceutical form(s):
  • Dispersible tablet
  • 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:
  19/07/2024
• Compliance check done:
  Ne

Decision

P/0243/2024: EMA decision of 19 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for dolutegravir / lamivudine (Dovato), (EMEA-001940-PIP01-16-M06)

Adopted Reference Number: EMA/297553/2024