Source: European Medicines Agency (EU) Revision Year: 2020 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 |
|---|
|
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 MSD 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 MSD 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).
Each 240 mg film-coated tablet contains less than 1 mmol sodium (23 mg).
Each 480 mg film-coated tablet contains less than 1 mmol sodium (23 mg).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Letermovir |
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. Letermovir is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose (E460) Film-coating: Lactose monohydrate |
240 mg film-coated tablets: Polyamide/Aluminium/PVC – Aluminium blister card. Each carton contains four (4) cardboard cards, each containing a 7-count blister card for a total of 28 tablets.
480 mg film-coated tablets: Polyamide/Aluminium/PVC – Aluminium blister cards. Each carton contains four (4) cardboard, each containing a 7-count blister card for a total of 28 tablets.
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
| 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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