EMEA-000968-PIP02-11-M05 - paediatric investigation plan

elvitegravir

Key facts

• Invented name:
  • Vitekta
  • Vitekta
• Active Substance:
  elvitegravir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0274/2016
• PIP number:
  EMEA-000968-PIP02-11-M05
• 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:
  07/10/2016

Decision

P/0274/2016: EMA decision of 7 October 2016 on the acceptance of a modification of an agreed paediatric investigation plan for eftrenonacog alfa (ALPROLIX), (EMEA-000914-PIP01-10-M03)

AdoptedReference Number: EMA/631038/2016