Lysodren

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mitotane

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

Overview

This is a summary of the European public assessment report (EPAR) for Lysodren. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Lysodren.

This EPAR was last updated on 18/02/2019

Authorisation details

Product details
Name
Lysodren
Agency product number
EMEA/H/C/000521
Active substance
Mitotane
International non-proprietary name (INN) or common name
mitotane
Therapeutic area (MeSH)
Adrenal Cortex Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XX23
OrphanOrphan

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
Laboratoire HRA Pharma
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
28/04/2004
Contact address

200 avenue de Paris
92 320 CHATILLON
France

Product information

20/12/2018 Lysodren - EMEA/H/C/000521 - IAIN/0020

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

Antineoplastic agents

Therapeutic indication

Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma.

The effect of Lysodren on non-functional adrenal cortical carcinoma is not established.

Assessment history

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