On 12 October 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Prevymis. The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme B.V.
The CHMP adopted a new indication for prevention of CMV disease in seronegative adults who received a kidney transplant from a CMV-seropositive donor. For information, the full indications for Prevymis will be as follows:1
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).
Prevymis is indicated for prophylaxis of CMV disease in CMV-seronegative adults who have received a kidney transplant from a CMV-seropositive donor [D+/R-].
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
1New text in bold
CHMP post-authorisation summary of positive opinion for Prevymis
English (EN) (138.27 KB - PDF)