Prevymis

RSS

letermovir

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

Overview

This is a summary of the European public assessment report (EPAR) for Prevymis. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Prevymis.

For practical information about using Prevymis, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 20/08/2018

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 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
Merck Sharp & Dohme B.V.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
08/01/2018
Contact address

Waarderweg 39
2031 BN Harlem
The Netherlands

Product information

23/07/2018 Prevymis - EMEA/H/C/004536 - T/0002

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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