Livtencity (maribavir)
- Region
- 🇪🇺 EU
- Active substance
- maribavir
- Company
- Takeda Pharmaceuticals International AG Ireland Branch
- Status
- Authorised
- Therapeutic area
- Cytomegalovirus Infections
- CHMP opinion
- Thu 15 Sep 2022
- EU approval
- Wed 09 Nov 2022
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/005787
- ATC
- J05AX10
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.