EMEA-002950-PIP01-20-M01 - paediatric investigation plan

lutetium (177Lu) oxodotreotide

Key facts

• Invented name:
  Lutathera
• Active substance:
  lutetium (177Lu) oxodotreotide
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0461/2023
• PIP number:
  EMEA-002950-PIP01-20-M01
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of gastroenteropancreatic neuroendocrine tumours
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2023
• Compliance check done:
  Yes
• Compliance procedure number:
  EMA/PE/0000224297
• Compliance opinion date:
  18/10/2024
• Compliance outcome:
  Positive

Decision

P/0461/2023 : EMA decision of of 1 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for lutetium (177Lu) oxodotreotide (Lutathera), (EMEA-002950-PIP01-20-M01)

Adopted Reference Number: EMA/526330/2023