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.
Prevymis : EPAR - Summary for the public (PDF/77.36 KB)
First published: 17/01/2018
Last updated: 17/01/2018
Prevymis : EPAR - Risk-management-plan summary (PDF/421.03 KB)
First published: 03/09/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Merck Sharp & Dohme B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
26/08/2019 Prevymis - EMEA/H/C/004536 - II/0011
- 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.
Antivirals for systemic use
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.