PREVYMIS Film-coated tablet Ref.[8782] Active ingredients: Letermovir

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Product name and form

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.

Qualitative and quantitative composition

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)
Croscarmellose sodium (E468)
Povidone (E1201)
Colloidal anhydrous silica (E551)
Magnesium stearate (E470b)

Film-coating:

Lactose monohydrate
Hypromellose (E464)
Titanium dioxide (E171)
Triacetin (E1518)
Iron oxide yellow (E172)
Iron oxide red (only for 480 mg tablets) (E172)
Carnauba wax (E903)

Pack sizes and marketing

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.

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization dates and numbers

EU/1/17/1245/001

EU/1/17/1245/002

Date of first authorisation: 8 January 2018

Drugs

Drug Countries
PREVYMIS Austria, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States

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