EU/3/02/102: Orphan designation for the treatment of adrenal cortical carcinoma
Mitotane
Table of contents
Overview
Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in April 2014 at the end of the period of market exclusivity.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
|
Intended use |
Treatment of adrenal cortical carcinoma
|
Orphan designation status |
Expired
|
EU designation number |
EU/3/02/102
|
Date of designation |
12/06/2002
|
Sponsor |
Laboratoire HRA Pharma
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 |
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Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in April 2014 at the end of the period of market exclusivity.
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.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: