LYNAVOY Film-coated tablet Ref.[117086] Active ingredients: Linerixibat

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland, D24 YK11

Product name and form

Lynavoy 40 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Purple, round, biconvex film-coated tablets (9 mm in diameter), debossed with "GS 3JG" on one side.

Qualitative and quantitative composition

Each film-coated tablet contains 40 mg linerixibat.

For the full list of excipients, see section 6.1.

Active Ingredient

Linerixibat is a locally acting, minimally absorbed reversible inhibitor of the ileal bile acid transporter (IBAT). It decreases the reabsorption of bile acids in the ileum leading to increased faecal elimination. Linerixibat improves pruritus in PBC patients which is assumed to be due to a decrease in mediators of pruritus including serum bile acids, lysophosphatidic acid (LPA) [via measurement of autotaxin as a surrogate] and interleukin 31 (IL-31).

List of Excipients

Tablet core:

Microcrystalline cellulose (E460)
Croscarmellose sodium (E468)
Magnesium stearate (E470b)

Tablet coating:

Hypromellose (E464)
Titanium dioxide (E171)
Macrogol (E1521)
Iron oxide black (E172)
Iron oxide red (E172)

Pack sizes and marketing

Opaque, white high-density polyethylene (HDPE) bottles with polypropylene child-resistant closures and polyethylene induction heat seal liner, containing a HDPE canister with silica gel desiccant.

Pack sizes available:

  • Single bottles containing 28 or 60 film-coated tablets.
  • Multipacks containing 180 (3 bottles of 60) film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland, D24 YK11

Marketing authorization dates and numbers

EU/1/26/2053/001-003

Drugs

Drug Countries
LYNAVOY Lithuania, United States

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