Prevymis (letermovir)
- Region
- 🇪🇺 EU
- Active substance
- letermovir
- Company
- Merck Sharp & Dohme B.V.
- Status
- Authorised
- Therapeutic area
- Cytomegalovirus Infections
- CHMP opinion
- Thu 12 Oct 2017
- EU approval
- Mon 08 Jan 2018
- Designations
- Orphan
- Application
- EMEA/H/C/004536
- ATC
- J05
- Official record
- www.ema.europa.eu
Indication
Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult and paediatric patients weighing at least 5 kg who are CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).Prevymis is indicated for prophylaxis of CMV disease in CMV-seronegative adult and paediatric patients weighing at least 40 kg who have received a kidney transplant from a CMV-seropositive donor [D+/R-].Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult and paediatric patients weighing at least 15 kg who are CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT). 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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