Basic Information
Livtencity
Regulatory Information
EMEA/H/C/005787
November 9, 2022
September 15, 2022
5
March 26, 2024
Company Information
Ireland
Block 2 Miesian Plaza 50-58 Baggot Street Lower Dublin 2 Co Dublin D02 HW68
TAKEDA PHARMACEUTICALS INTERNATIONAL AG IRELAND BRANCH
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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.