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EMA Product

Lutathera

Product approved by European Medicines Agency (EU)

Basic Information

Lutathera

Regulatory Information

EMEA/H/C/004123

Authorised

September 26, 2017

July 20, 2017

16

April 3, 2025

Company Information

France

Advanced Accelerator Applications 8-10 Rue Henri Sainte-Claire Deville 92500 Rueil-Malmaison

ADVANCED ACCELERATOR APPLICATIONS

Drug Classification

Orphan Medicine

Active Ingredients

Active Substances Detail

Detailed Information

Therapeutic Indication

### 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.

Overview Summary

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.

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