MHRA-100719-PIP01-22

Key Facts

Active Substance
Active Substance:
  • LUTETIUM (177LU) OXODOTREOTIDE
Invented Name
  • Lutathera 370 MBq/mL solution for infusion
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
PIP Number MHRA-100719-PIP01-22
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of gastroenteropancreatic neuroendocrine tumours
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):LUTETIUM (177LU) OXODOTREOTIDE.pdf
Published Date 30/06/2023