EMEA-001733-PIP02-15-M02 - paediatric investigation plan

gemtuzumab ozogamicin

Key facts

• Invented name:
  Mylotarg
• Active Substance:
  gemtuzumab ozogamicin
• Therapeutic area:
  Oncology
• Decision number:
  P/0014/2022
• PIP number:
  EMEA-001733-PIP02-15-M02
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of acute myeloid leukaemia
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/01/2022

Decision

P/0014/2022 : EMA decision of 31 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for gemtuzumab ozogamicin (Mylotarg), (EMEA-001733-PIP02-15-M02)

AdoptedReference Number: EMA/18515/2022