EU/3/07/519: Orphan designation for the prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity
Table of contents
On 18 December 2007, orphan designation (EU/3/07/519) was granted by the European Commission to ViroPharma Limited, United Kingdom, for maribavir for the prevention of cytomegalovirus (CMV) disease in patients with impaired cell mediated immunity deemed at risk.
The medicinal product has been authorised in the EU as Livtencity since 09 November 2022.
Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity
|Orphan designation status||
|EU designation number||
|Date of designation||
Takeda Pharmaceuticals International AG Ireland Branch
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 orphan medicine assessment report .
|October 2022||The sponsor's address was updated in October 2022.|
|September 2021||The sponsorship was transferred to Takeda Pharmaceuticals International AG Ireland Branch.|
|March 2016||The sponsorship was transferred to Shire Pharmaceuticals Ireland Limited, Ireland.|
|February 2016||ViroPharma SPRL changed name to Shire Services BVBA.|
|February 2009||The sponsorship was transferred to ViroPharma SPRL, Belgium.|
Documents related to this orphan designation evaluation
EU/3/07/519: Public summary of positive opinion for orphan designation of maribavir for the prevention of cytomegalovirus (CMV) disease in patients with impaired cell mediated immunity deemed at risk (PDF/145.32 KB)
First published: 23/09/2009
Last updated: 31/05/2011
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: