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
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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.
Merck Sharp & Dohme B.V.
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23/07/2018 Prevymis - EMEA/H/C/004536 - T/0002
- 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.
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.