PREVYMIS Granules Ref.[115351] Active ingredients: Letermovir

Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Product name and form

PREVYMIS 20 mg granules in sachet.

PREVYMIS 120 mg granules in sachet.

Pharmaceutical Form
Granules in sachet (granules). Beige granules approximately 2 mm in diameter.

Qualitative and quantitative composition

PREVYMIS 20 mg granules in sachet:

Each sachet contains 20 mg of letermovir.

PREVYMIS 120 mg granules in sachet:

Each sachet contains 120 mg of letermovir.

Excipients with known effect:

Each 20 mg granules in sachet contains 1.7 mg of lactose (as monohydrate).

Each 120 mg granules in sachet contains 9.9 mg of lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient
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.

List of Excipients
Microcrystalline cellulose (E460) Croscarmellose sodium (E468) Povidone (E1201) Colloidal anhydrous silica (E551) Magnesium stearate (E470b) Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin Iron oxide yellow (E172) Iron oxide red (E172)

Pack sizes and marketing

Sachets consisting of Polyethylene terephthalate (PET)/Aluminum Foil/Linear low-density polyethylene (LLDPE) Each carton contains 30 sachets.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/17/1245/005
EU/1/17/1245/006

Date of first authorisation: 8 January 2018
Date of latest renewal: 24 August 2022

Drugs

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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