EU/3/12/1020

About

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
Disease / condition
Treatment of idiopathic pulmonary fibrosis
Date of first decision
17/07/2012
Outcome
Positive
EU designation number
EU/3/12/1020

Review of designation

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

Sponsor's contact details

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

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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