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 18/01/2023

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
Publication details
Marketing-authorisation holder
HRA Pharma Rare Diseases
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
28/04/2004
Contact address

200 avenue de Paris
92320 Chatillon
France

Product information

01/12/2022 Lysodren - EMEA/H/C/000521 - II/0026

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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