EMEA-001219-PIP01-11-M06 - paediatric investigation plan

dolutegravir

abacavir

lamivudine

Key facts

• Invented name:
  • Triumeq
  • Triumeq
• Active substance:
  • dolutegravir
  • abacavir
  • lamivudine
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0038/2023
• PIP number:
  EMEA-001219-PIP01-11-M06
• Pharmaceutical form(s):
  • Film-coated tablet
  • Dispersible 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:
  31/01/2023
• Compliance check done:
  Da
• Compliance procedure number:
  EMEA-C-001219-PIP01-11-M06
• Compliance opinion date:
  08/09/2023
• Compliance outcome:
  Positive

Decision

P/0038/2023 : EMA decision of 31 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for dolutegravir / abacavir / lamivudine (Triumeq), (EMEA-001219-PIP01-11-M06)

Reference Number: EMA/950358/2022