Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
PREVYMIS 240 mg concentrate for solution for infusion.
PREVYMIS 480 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear, colourless liquid. pH between 7 and 8. |
PREVYMIS 240 mg concentrate for solution for infusion:
Each vial contains 240 mg (12 mL per vial) of letermovir.
Each mL contains 20 mg of letermovir.
PREVYMIS 480 mg concentrate for solution for infusion:
Each vial contains 480 mg (24 mL per vial) of letermovir.
Each mL contains 20 mg of letermovir.
Excipients with known effect:
This medicinal product contains 23 mg (1 mmol) sodium per 240 mg vial.
This medicinal product contains 46 mg (2 mmol) sodium per 480 mg vial.
Each 240 mg dose (12 mL vial) of this medicinal product contains 1800 mg hydroxypropylbetadex (cyclodextrin).
Each 480 mg dose (24 mL vial) of this medicinal product contains 3600 mg hydroxypropylbetadex (cyclodextrin).
For additional information, see section 4.2.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Letermovir inhibits the CMV DNA terminase complex which is required for cleavage and packaging of viral progeny DNA. Letermovir affects the formation of proper unit length genomes and interferes with virion maturation. |
| List of Excipients |
|---|
|
Hydroxypropylbetadex (cyclodextrin) |
Type I (30 mL) clear glass vial with a 20 mm fluorocoated chlorobutyl stopper with aluminium flip-off cap containing 12 mL (medium green cap) or 24 mL (dark blue cap) of solution.
Pack size: 1 vial.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
EU/1/17/1245/003
EU/1/17/1245/004
Date of first authorisation: 8 January 2018
Date of latest renewal: 24 August 2022
| Drug | Countries | |
|---|---|---|
| PREVYMIS | Austria, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.