EU/3/02/102
Table of contents
About
Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in April 2014 at the end of the period of market exclusivity.
On 12 June 2002, orphan designation (EU/3/02/102) was granted by the European Commission to Laboratoire HRA Pharma, France, for mitotane for the treatment of adrenal cortical carcinoma.
Mitotane has been authorised in the EU as Lysodren since 28 April 2004.
For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.
Key facts
Active substance |
Mitotane
|
Medicine name |
Lysodren
|
Disease / condition |
Treatment of adrenal cortical carcinoma
|
Date of first decision |
12/06/2002
|
Outcome |
Expired
|
EU designation number |
EU/3/02/102
|
Review of designation
Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in April 2014 at the end of the period of market exclusivity.
Sponsor's contact details
19, rue Frédérick Lemaitre
F-75020 Paris
France
Tel. +33 1 40 33 11 30
Fax +33 1 40 33 12 31
http://www.hra-pharma.com/about_contact.php
Patients' organisations
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.