Anpheros Search · Treatment

Letermovir

Also known as: Prevymis

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In short

In the European Union, letermovir is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in CMV-seropositive recipients of an allogeneic haematopoietic stem cell transplant. In the European Union, it is also indicated for prophylaxis of CMV disease in patients weighing at least 40 kg who received a kidney transplant from a CMV-seropositive donor. In the United States, it is indicated for prophylaxis of CMV infection and disease in pediatric and adult patients who are CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant. The United States also approves it for prophylaxis of CMV disease in high-risk kidney transplant recipients who are 12 years of age and older and weigh at least 40 kg. Letermovir is listed by the cited source as having an approved use for cytomegaloviral disease.

From: Source: European Medicines Agency (EMA), Prevymis — EPAR, 12/12/2025. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
1988648 letermovir
EMA
EMEA/H/C/004536

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Prevymis

Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult and paediatric patients weighing at least 5 kg who are CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).Prevymis is indicated for prophylaxis of CMV disease in CMV-seronegative adult and paediatric patients weighing at least 40 kg who have received a kidney transplant from a CMV-seropositive donor [D+/R-].Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult and paediatric patients weighing at least 15 kg who are 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.

Source: European Medicines Agency (EMA), Prevymis — EPAR, 12/12/2025. © European Medicines Agency.

Document date: 12/12/2025 · Official document →

FDA (USA) PREVYMIS

1 INDICATIONS AND USAGE PREVYMIS is a CMV DNA terminase complex inhibitor indicated for: Prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). ( 1.1 ) Prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]). ( 1.2 ) 1.1 CMV Prophylaxis in Hematopoietic Stem Cell Transplant (HSCT) Recipients PREVYMIS ® is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). 1.2 CMV Prophylaxis in Kidney Transplant Recipients PREVYMIS is indicated for prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]).

Data provided by the U.S. Food and Drug Administration.

Document date: 20260114 · Official document →

Related terms in the cited sources

Has an official indication for

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What people report

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External resources

Questions

What is Letermovir approved for in the European Union?

Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult and paediatric patients weighing at least 5 kg who are CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).Prevymis is indicated for prophylaxis of CMV disease in CMV-seronegative adult and paediatric patients weighing at least 40 kg who have received a kidney transplant from a CMV-seropositive donor [D+/R-].Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult and paediatric patients weighing at least 15 kg who are 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. (Source: European Medicines Agency (EMA), Prevymis — EPAR, 12/12/2025. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • Data provided by the U.S. Food and Drug Administration.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Prevymis — EPAR, 12/12/2025. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →