REZUROCK Film-coated tablet Ref.[116476] Active ingredients: Belumosudil

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: Sanofi Winthrop Industrie, 82 Avenue Raspail, 94250 Gentilly, France

Product name and form

REZUROCK 200 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Pale yellow to yellow, oval shaped tablet, with "KDM" on one side and "200" on the other side, with dimensions of 7.4 x 14.8 mm.

Qualitative and quantitative composition

Each film-coated tablet contains belumosudil mesylate equivalent to 200 mg belumosudil.

For the full list of excipients, see section 6.1.

Active Ingredient

Belumosudil is a selective Rho-associated, coiled-coil containing protein kinase-2 (ROCK2) inhibitor that mediates signalling in immune cellular function and fibrotic pathways.

List of Excipients

Tablet core:

Cellulose, microcrystalline
Hypromellose
Croscarmellose sodium
Magnesium stearate
Silica, colloidal anhydrous

Tablet coating:

Polyvinyl alcohol (E1203)
Titanium dioxide (E171)
Macrogol (E1521)
Talc (E553b)
Iron oxide yellow (E172)

Pack sizes and marketing

High-density polyethylene (HDPE) bottle with polypropylene child-resistant closure and a silica gel desiccant.

Pack size: 28 or 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Sanofi Winthrop Industrie, 82 Avenue Raspail, 94250 Gentilly, France

Marketing authorization dates and numbers

EU/1/26/2015/001
EU/1/26/2015/002

Drugs

Drug Countries
REZUROCK Austria, Canada, Estonia, Lithuania, United States

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