EMEA-002950-PIP01-20 - paediatric investigation plan

lutetium (177Lu) oxodotreotide

Key facts

• Invented name:
  Lutathera
• Active Substance:
  lutetium (177Lu) oxodotreotide
• Therapeutic area:
  Oncology
• Decision number:
  P/0503/2021
• PIP number:
  EMEA-002950-PIP01-20
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of gastroenteropancreatic neuroendocrine tumours
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  03/12/2021

Decision

P/0503/2021 : EMA decision of 3 December 2021 on the agreement of a paediatric investigation plan and on the granting of a waiver for lutetium (177Lu) oxodotreotide (Lutathera), (EMEA-002950-PIP01-20)

AdoptedReference Number: EMA/624371/2021