EU/3/16/1724: Orphan designation for the treatment of systemic sclerosis

nintedanib

Overview

Please note that this product was withdrawn from the Community register of designated orphan medicinal products in May 2020 on request of the of the marketing authorisation holder at the time of the granting of a change to the terms of the marketing authorisation.

On 29 August 2016, orphan designation (EU/3/16/1724) was granted by the European Commission to Boehringer Ingelheim International GmbH, Germany, for nintedanib for the treatment of systemic sclerosis.

Nintedanib for treatment of systemic sclerosis has been authorised in the EU as Ofev 17 April 2020.

 

Key facts

Active substance
nintedanib
Medicine name
Ofev
Intented use
Treatment of systemic sclerosis
Orphan designation status
Withdrawn
EU designation number
EU/3/16/1724
Date of designation
29/08/2016
Sponsor
Boehringer Ingelheim International GmbH
Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany
Tel. +49 61 32770
Fax +49 61 32720
E-mail: info@boehringer-ingelheim.de

Review of designation

Please note that this product was withdrawn from the Community register of designated orphan medicinal products in May 2020 on request of the of the marketing authorisation holder at the time of the granting of a change to the terms of the marketing authorisation.  

The Committee for Orphan Medicinal Products reviewed the orphan designation of Ofev at the time of change to the terms of the marketing authorisation, and confirmed that the orphan designation should be maintained.

More information is available in the PDF icon orphan medicine assessment report .

Documents related to this orphan designation evaluation

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:

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