LIVTENCITY Film-coated tablet Ref.[50474] Active ingredients: Maribavir

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Takeda Pharmaceuticals International AG Ireland Branch, Block 3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 Y754, Ireland E-mail: medinfoEMEA@takeda.com

Product name and form

LIVTENCITY 200 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Blue, oval shaped convex tablet of 15.5 mm, debossed with “SHP” on one side and “620” on the other side.

Qualitative and quantitative composition

Each tablet contains 200 mg maribavir.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Maribavir

Maribavir is a competitive inhibitor of the UL97 protein kinase. UL97 inhibition occurs at the viral DNA replication phase, inhibiting UL97 serine/threonine kinase by competitively inhibiting the binding of ATP to the kinase ATP-binding site, without affecting the concatemer maturation process, abolishing phosphotransferase inhibiting CMV DNA replication and maturation, CMV DNA encapsidation, and CMV DNA nuclear egress.
List of Excipients

Tablet core:

Microcrystalline cellulose (E460(i))
Sodium starch glycolate
Magnesium stearate (E470b)

Film-coating:

Polyvinyl alcohol (E1203)
Macrogol (polyethylene glycol) (E1521)
Titanium dioxide (E171)
Talc (E553b)
Brilliant blue FCF aluminum lake (EU) (E133)

Pack sizes and marketing

High-density polyethylene (HDPE) bottles with child resistant cap.

Pack-sizes of 28 or 56 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Takeda Pharmaceuticals International AG Ireland Branch, Block 3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 Y754, Ireland
E-mail: medinfoEMEA@takeda.com

Marketing authorization dates and numbers

EU/1/22/1672/001
EU/1/22/1672/002

Drugs

Drug Countries
LIVTENCITY Austria, Canada, Spain, France, Croatia, Israel, Italy, Lithuania, Romania, United States
 
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