EU/3/12/1020: Orphan designation for the treatment of idiopathic pulmonary fibrosis

Recombinant human pentraxin-2

Overview

On 17 July 2012, orphan designation (EU/3/12/1020) was granted by the European Commission to Appletree Europe S.a.r.l., Luxemburg, for recombinant human pentraxin-2 for the treatment of idiopathic pulmonary fibrosis.

The sponsorship was transferred to FGK Representative Service GmbH, Germany, in April 2014.

The sponsorship was transferred to Roche Registration GmbH, Germany, in April 2020.

Key facts

Active substance
Recombinant human pentraxin-2
Intended use
Treatment of idiopathic pulmonary fibrosis
Orphan designation status
Positive
EU designation number
EU/3/12/1020
Date of designation
17/07/2012
Sponsor

Roche Registration GmbH
Emil-Barell-Strasse 1
Grenzach
79639 Grenzach-Wyhlen
Germany
E-mail: info.orphan@roche.com

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

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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