EU/3/13/1133: Orphan designation for the treatment of cytomegalovirus disease in patients with impaired cell-mediated immunity

Maribavir

Overview

On 7 June 2013, orphan designation (EU/3/13/1133) was granted by the European Commission to ViroPharma SPRL, Belgium, for maribavir for the treatment of cytomegalovirus disease in patients with impaired cell-mediated immunity.

The sponsorship was transferred to ViroPharma SPRL, Belgium, in February 2009.

In February 2016, ViroPharma SPRL changed name to Shire Services BVBA.

The sponsorship was transferred to Shire Pharmaceuticals Ireland Limited, Ireland, in March 2016.

The sponsorship was transferred to Takeda Pharmaceuticals International AG Ireland Branch in September 2021.

Key facts

Active substance
Maribavir
Intented use
Treatment of cytomegalovirus disease in patients with impaired cell-mediated immunity
Orphan designation status
Positive
EU designation number
EU/3/13/1133
Date of designation
07/06/2013
Sponsor

Takeda Pharmaceuticals International AG Ireland Branch
Block 3 Miesian Plaza
50-58 Baggott Street Lower
Dublin 2
D02 Y754
Co. Dublin
Ireland
Tel: +1 800937970
E-mail: medinfoemea@takeda.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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