WAYRILZ Film-coated tablet Ref.[116156] Active ingredients: Rilzabrutinib

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: Sanofi B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands

Product name and form

WAYRILZ 400 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Orange tablet, capsule-shaped of 16.6 × 8.1 mm size, debossed with "P" on one side and "400" on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 400 mg rilzabrutinib.

Excipient with known effect:

Each tablet contains 0.8 mg of sunset yellow FCF (E110).

For the full list of excipients, see section 6.1

Active Ingredient

Rilzabrutinib is a selective, covalent, reversible inhibitor of Bruton's tyrosine kinase (BTK), with a tailored residence time at BTK to reduce off-target effects. In immune thrombocytopenia (ITP), rilzabrutinib mediates its therapeutic effect through multi-immune modulation by inhibiting B cell activation, interruption of FcγR mediated phagocytosis, and potentially amelioration of chronic inflammation associated with ITP.
List of Excipients

Tablet core:

Microcrystalline cellulose (E460(i))
Crospovidone (Type A) (E1202)
Sodium stearyl fumarate

Film coating:

Polyvinyl alcohol (E1203)
Macrogol (E1521)
Titanium dioxide (E171)
Talc (E553b)
Sunset Yellow FCF (E110)

Pack sizes and marketing

White, opaque polyvinyl chloride (PVC)/polychlorotrifluoroethylene (PCTFE)-aluminium blister pack in a cardboard wallet with sun/moon symbols containing 28 film-coated tablets.

Pack sizes:

Each blister wallet contains 28 film-coated tablets.

Each pack contains:

  • 28 film-coated tablets
  • 56 film-coated tablets (2 blister wallets of 28)
  • 196 film-coated tablets (7 blister wallets of 28).

Not all pack sizes may be marketed.

Marketing authorization holder

Sanofi B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands

Marketing authorization dates and numbers

EU/1/25/1974/001
EU/1/25/1974/002
EU/1/25/1974/003

Drugs

Drug Countries
WAYRILZ Austria, Lithuania, Romania, United States
 
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