EU/3/10/749: Orphan designation for the treatment of haemophagocytic lymphohistiocytosis

Recombinant human anti-interferon gamma monoclonal antibody (emapalumab)

Table of contents

Overview

On 9 June 2010, orphan designation (EU/3/10/749) was granted by the European Commission to NovImmune B.V., the Netherlands, for recombinant human anti-interferon gamma monoclonal antibody for the treatment of haemophagocytic lymphohistiocytosis.

This medicine is now known as emapalumab.

The sponsorship was transferred to Swedish Orphan Biovitrum AB (publ), Sweden, in June 2019.

Key facts

Active substance
Recombinant human anti-interferon gamma monoclonal antibody (emapalumab)
Intended use
Treatment of haemophagocytic lymphohistiocytosis
Orphan designation status
Positive
EU designation number
EU/3/10/749
Date of designation
09/06/2010
Sponsor

Swedish Orphan Biovitrum AB (publ)
SE 112 76 Stockholm
Sweden
E-mail: info@sobi.com

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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