EU/3/02/102

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Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in April 2014 at the end of the period of market exclusivity.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Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in April 2014 at the end of the period of market exclusivity.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

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

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.

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