EU/3/13/1123

About

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 has been authorised in the EU as Ofev since 15 January 2015.

Key facts

Active substance
nintedanib
Medicine name
Ofev
Disease / condition
Treatment of idiopathic pulmonary fibrosis
Date of first decision
26/04/2013
Outcome
Positive
EU designation number
EU/3/13/1123

Review of designation

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.

Sponsor's contact details

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

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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