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 medicinal product has been authorised in the EU as Livtencity since 09 November 2022.

Key facts

Active substance
Maribavir
Intended 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 2
Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
D02 HW68
Ireland
Tel: +1 800937970
E-mail: medinfoEMEA@takeda.com

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Livtencity at the time of marketing authorisation, and confirmed that the orphan designation should be maintained. More information is available in the PDF icon orphan medicine assessment report .

Update history

DateUpdate
October 2022The sponsor's address was updated in October 2022.
September 2021The sponsorship was transferred to Takeda Pharmaceuticals International AG Ireland Branch.
March 2016The sponsorship was transferred to Shire Pharmaceuticals Ireland Limited, Ireland.
February 2016ViroPharma SPRL changed name to Shire Services BVBA.
February 2009The sponsorship was transferred to ViroPharma SPRL, Belgium.

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:

Related content

How useful was this page?

Add your rating