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.
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
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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.