Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Jaypirca 50 mg film-coated tablets.
Jaypirca 100 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Jaypirca 50 mg film-coated tablets: Blue, 9 × 9 mm, arc-triangle shaped tablet debossed with “Lilly 50” on one side and “6902” on the other side. Jaypirca 100 mg film-coated tablets: Blue, 10 mm, round tablet debossed with “Lilly 100” on one side and “7026” on the other side. |
Each film-coated tablet contains 50 mg of pirtobrutinib.
Excipients with known effect: Each film-coated tablet contains 38 mg of lactose (as monohydrate).
Each film-coated tablet contains 100 mg of pirtobrutinib.
Excipients with known effect: Each film-coated tablet contains 77 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pirtobrutinib |
Pirtobrutinib is a reversible, noncovalent inhibitor of BTK. BTK is a signalling protein of the B-cell antigen receptor (BCR) and cytokine receptor pathways. In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. Pirtobrutinib binds to wild type BTK as well as BTK harboring C481 mutations leading to inhibition of BTK kinase activity. |
| List of Excipients |
|---|
|
Tablet core: Hypromellose acetate succinate Film-coating: Hypromellose |
Jaypirca 50 mg film-coated tablets: Polyvinylchloride/polychlorotrifluoroethylene blisters sealed with an aluminium foil in packs of 28, 30 or 84 film-coated tablets.
Jaypirca 100 mg film-coated tablets: Polyvinylchloride/polychlorotrifluoroethylene blisters sealed with an aluminium foil in packs of 28, 30, 56, 60, 84 or 168 film-coated tablets.
Not all pack sizes may be marketed.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
EU/1/23/1738/001
EU/1/23/1738/002
EU/1/23/1738/003
EU/1/23/1738/004
EU/1/23/1738/005
EU/1/23/1738/006
EU/1/23/1738/007
EU/1/23/1738/008
EU/1/23/1738/009
| Drug | Countries | |
|---|---|---|
| JAYPIRCA | Austria, France, Croatia, Ireland, Italy, Lithuania, Romania, United States |
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