EU/3/13/1123:

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Please note that this product was withdrawn from the Community register of designated orphan medicinal products in May 2020 on request of the of the marketing authorisation holder at the time of the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 26 April 2013 orphan designation (EU/3/13/1123) was granted by the European Commission to Boehringer Ingelheim International GmbH, Germany, for nintedanib for the treatment of idiopathic pulmonary fibrosis.

Nintedanib for treatment of idiopathic pulmonary fibrosis has been authorised in the EU as Ofev since 15 January 2015.

Key facts

Active substance
nintedanib
Medicine name
Ofev
Intented use
Treatment of idiopathic pulmonary fibrosis
Orphan designation status
Withdrawn
EU designation number
EU/3/13/1123
Date of designation
26/04/2013
Sponsor
Boehringer Ingelheim International GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein
Germany
Tel. +49 613 2770
Fax +49 613 2720
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Please note that this product was withdrawn from the Community register of designated orphan medicinal products in May 2020 on request of the of the marketing authorisation holder at the time of the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.  

During its meeting of 9 to 11 December 2014, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/13/1123 for Ofev (nintedanib) as an orphan medicinal product for the treatment of idiopathic pulmonary fibrosis. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other methods of treatment. As other methods of treatment are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with idiopathic pulmonary fibrosis. The COMP recommended that the orphan designation of the medicine be maintained1.


1The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with a comparable therapeutic indication cannot be placed on the market.

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (PDF/123.51 KB)


    First published: 17/02/2015
    Last updated: 09/06/2020
    EMA/COMP/766700/2014

  • 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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