Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
PREVYMIS 240 mg film-coated tablets.
PREVYMIS 480 mg film-coated tablets.
| Pharmaceutical Form |
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Film-coated tablet (tablet). PREVYMIS 240 mg film-coated tablets: Yellow oval tablet of dimensions 16.5 mm x 8.5 mm, debossed with “591” on one side and corporate logo on the other side. PREVYMIS 480 mg film-coated tablets: Pink oval, bi-convex tablet of dimensions 21.2 mm x 10.3 mm, debossed with “595” on one side and corporate logo on the other side. |
PREVYMIS 240 mg film-coated tablets: Each film-coated tablet contains 240 mg of letermovir.
PREVYMIS 480 mg film-coated tablets: Each film-coated tablet contains 480 mg of letermovir.
Excipients with known effect:
Each 240 mg film-coated tablet contains 4 mg of lactose (as monohydrate).
Each 480 mg film-coated tablet contains 6.4 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient |
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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 |
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Tablet core: Microcrystalline cellulose (E460) Film-coating: Lactose monohydrate |
Packs of 28x1 tablets in Polyamide/Aluminium/PVC – Aluminium perforated unit dose blisters.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
EU/1/17/1245/001
EU/1/17/1245/002
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 |
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