Lutathera

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lutetium (177Lu) oxodotreotide

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 11/04/2018

Authorisation details

Product details
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
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
Marketing-authorisation holder
Advanced Accelerator Applications
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
26/09/2017
Contact address
20 rue Diesel
01630 Saint Genis Pouilly
France

Product information

21/03/2018 Lutathera - EMEA/H/C/004123 - IAIN/0003

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.

Assessment history

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