SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| PREVYMIS | 240 mg | Film-coated tablet · Oral use | 28 Blister | SAR 20693.50 | NCE · Prescription | MERCK SHARP & DOHME | Valid |
| PREVYMIS | 20 mg/ml | Concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 884.95 | NCE · Prescription | Merck Sharp & Dohme B.V | Valid |
| PREVYMIS | 480 mg | Concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 1452.00 | NCE · Prescription | Merck Sharp & Dohme B.V | Valid |
| PREVYMIS | 480 mg | Film-coated tablet · Oral use | 28 Blister | SAR 40656.00 | NCE · Prescription | MERCK SHARP & DOHME | Valid |
Indications — CHI Daman Drug Formulary
ANTIMICROBIAL PROPHYLAXIS IN CANCER PATIENTS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| PREVYMIS | 240MG; 480MG | tablet · oral | MERCK SHARP DOHME | Prescription | 8 Nov 2017 |
| PREVYMIS | 240MG/12ML (20MG/ML); 480MG/24ML (20MG/ML) | solution · intravenous | MERCK SHARP DOHME | Prescription | 8 Nov 2017 |
| PREVYMIS | 20MG/PACKET; 120MG/PACKET | pellets · oral | MSD | Prescription | 30 Aug 2024 |
EMA European Union — centrally authorised medicines
Prevymis Merck Sharp & Dohme B.V. · Authorised · authorised 8 Jan 2018 · ATC J05
Therapeutic indication (EMA)
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.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| LUPIN-LETERMOVIR | 02559323 | 240 MG | TABLET · ORAL | LUPIN PHARMA CANADA LIMITED |
| LUPIN-LETERMOVIR | 02559331 | 480 MG | TABLET · ORAL | LUPIN PHARMA CANADA LIMITED |
| PREVYMIS | 02469367 | 20 MG / ML | SOLUTION · INTRAVENOUS | MERCK CANADA INC |
| PREVYMIS | 02469375 | 240 MG | TABLET · ORAL | MERCK CANADA INC |
| PREVYMIS | 02469383 | 480 MG | TABLET · ORAL | MERCK CANADA INC |
Safety signals and safety-related labeling changes
- US FDA 30 Aug 2024 PREVYMIS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 30 Aug 2024 PREVYMIS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
All safety entries for letermovir →
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.