Prevymis - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

letermovir

Opinion

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.

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¹New text in bold

CHMP post-authorisation summary of positive opinion for Prevymis

AdoptedReference Number: EMA/454102/2023

Key facts

• Name of medicine:
  Prevymis
• EMA product number:
  EMEA/H/C/004536
• Active substance:
  Letermovir
• International non-proprietary name (INN) or common name:
  letermovir
• Therapeutic area (MeSH):
  Cytomegalovirus Infections
• Anatomical therapeutical chemical (ATC) code:
  J05
• 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.

• Marketing authorisation holder:
  Merck Sharp & Dohme B.V.
• Date of opinion:
  12/10/2023
• Status:
  Positive