Livtencity
maribavir
Table of contents
Overview
Livtencity is an antiviral medicine used to treat illness caused by cytomegalovirus (CMV) in adults who have had a haematopoietic stem cell transplant or an organ transplant. It is used in patients whose CMV illness has not responded to at least one other treatment, including ganciclovir, valganciclovir, cidofovir or foscarnet.
Haematopoietic stem cell transplantation involves using stem cells from a donor to replace the recipient’s bone marrow cells. The donated stem cells will form new bone marrow that produces healthy blood cells.
CMV is a common virus that usually only causes mild infection in healthy people. After infection, the virus remains in the body in an inactive form and does not cause harm. However, CMV can become active and cause illness in patients whose immune system (the body’s natural defences) is weakened, such as those who have had a stem cell or organ transplant.
CMV disease is rare, and Livtencity was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 18 December 2007 and 7 June 2013. Further information on the orphan designations can be found here: ema.europa.eu/medicines/human/orphan-designations/eu307519 and ema.europa.eu/en/medicines/human/orphan-designations/eu-3-13-1133.
Livtencity contains the active substance maribavir.
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Livtencity : EPAR - Medicine Overview (PDF/131.56 KB)
First published: 24/11/2022
EMA/880622/2022 -
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Livtencity : EPAR - Risk Management Plan (PDF/566.58 KB)
First published: 24/11/2022
Authorisation details
| Product details | |
|---|---|
| Name |
Livtencity
|
| Agency product number |
EMEA/H/C/005787
|
| Active substance |
Maribavir
|
| International non-proprietary name (INN) or common name |
maribavir
|
| Therapeutic area (MeSH) |
Cytomegalovirus Infections
|
| Anatomical therapeutic chemical (ATC) code |
J05AX10
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Takeda Pharmaceuticals International AG Ireland Branch
|
| Revision |
4
|
| Date of issue of marketing authorisation valid throughout the European Union |
09/11/2022
|
| Contact address |
Block 2 Miesian Plaza |
Product information
04/07/2023 Livtencity - EMEA/H/C/005787 - IB/0005
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antivirals for systemic use
Therapeutic indication
LIVTENCITY is indicated for the treatment of cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT).
Consideration should be given to official guidance on the appropriate use of antiviral agents.