Lutathera
lutetium (177Lu) oxodotreotide
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Lutathera. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Lutathera.
For practical information about using Lutathera, patients should read the package leaflet or contact their doctor or pharmacist.
Authorisation details
Product details | |
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Name |
Lutathera
|
Agency product number |
EMEA/H/C/004123
|
Active substance |
lutetium (177Lu) oxodotreotide
|
International non-proprietary name (INN) or common name |
lutetium (177Lu) oxodotreotide
|
Therapeutic area (MeSH) |
Neuroendocrine Tumors
|
Anatomical therapeutic chemical (ATC) code |
V10XX04
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Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
Publication details | |
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Marketing-authorisation holder |
Advanced Accelerator Applications
|
Revision |
4
|
Date of issue of marketing authorisation valid throughout the European Union |
26/09/2017
|
Contact address |
Product information
21/01/2021 Lutathera - EMEA/H/C/004123 - II/0022
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Other therapeutic radiopharmaceuticals
Therapeutic indication
Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP‑NETs) in adults.