EMEA-002311-PIP01-17-M02 - paediatric investigation plan

Ibalizumab

Key facts

• Invented name:
  Trogarzo
• Active substance:
  Ibalizumab
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0248/2021
• PIP number:
  EMEA-002311-PIP01-17-M02
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/07/2021
• Compliance check done:
  Nein

Decision

P/0248/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ibalizumab (Trogarzo), (EMEA-002311-PIP01-17-M02)

Adopted Reference Number: EMA/318043/2021