EMEA-001733-PIP02-15-M03 - paediatric investigation plan

gemtuzumab ozogamicin

Key facts

• Invented name:
  Mylotarg
• Active substance:
  gemtuzumab ozogamicin
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0314/2024
• PIP number:
  EMEA-001733-PIP02-15-M03
• 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:
  13/09/2024
• Compliance check done:
  No

Decision

P/0314/2024 : EMA decision of 13 September 2024 on the acceptance of a modification of an agreed paediatric investigation plan for gemtuzumab ozogamicin (Mylotarg), (EMEA-001733-PIP02-15-M03)

Adopted Reference Number: EMA/410855/2024