EU/3/13/1116

About

On 12 March 2013, orphan designation (EU/3/13/1116) was granted by the European Commission to Glaxo Group Ltd, United Kingdom, for mepolizumab for the treatment of Churg-Strauss syndrome.

The sponsorship was transferred to GlaxoSmithKline Trading Services Limited, Ireland, in May 2018.

The sponsor’s address was updated in April 2020. In April 2020, GlaxoSmithKline Trading Services Limited changed name to GlaxoSmithKline (Ireland) Limited.

Key facts

Active substance
Mepolizumab
Disease / condition
Treatment of Churg-Strauss syndrome
Date of first decision
12/03/2013
Outcome
Positive
EU designation number
EU/3/13/1116

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

GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland
E-mail: customercontactuk@gsk.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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