Prevymis

RSS

letermovir

Authorised
This medicine is authorised for use in the European Union.

Overview

Prevymis is an antiviral medicine used to prevent illness caused by cytomegalovirus (CMV) in adults having an allogeneic haematopoietic stem cell transplant. Allogeneic haematopoietic stem cell transplantation involves using stem cells from a donor to replace the recipient’s bone marrow cells to form new bone marrow that produces healthy blood cells.

Many people have CMV in their body but it is usually inactive and it does not cause harm. However, CMV can become active in patients whose immune system (the body’s natural defences) is weakened such as those having stem cell transplants.

CMV disease is rare, and Prevymis was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 15 April 2011.

This EPAR was last updated on 27/09/2019

Authorisation details

Product details
Name
Prevymis
Agency product number
EMEA/H/C/004536
Active substance
Letermovir
International non-proprietary name (INN) or common name
letermovir
Therapeutic area (MeSH)
Cytomegalovirus Infections
Anatomical therapeutic chemical (ATC) code
J05
Additional monitoringAdditional 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.

OrphanOrphan

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
Merck Sharp & Dohme B.V.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
08/01/2018
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

26/08/2019 Prevymis - EMEA/H/C/004536 - II/0011

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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult 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.

Assessment history

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