Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
SOTYKTU 6 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Pink, round, biconvex, film-coated tablet of 8 mm diameter, printed with “BMS 895”, and “6 mg” on one side in two lines, plain on the other side. |
Each film-coated tablet contains 6 mg of deucravacitinib.
Excipient with known effect: Each film-coated tablet contains 44 mg of lactose (see section 4.4).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Deucravacitinib |
Deucravacitinib selectively inhibits the TYK2 enzyme (TYK2 belongs to the JAK family). TYK2 mediates signalling of interleukin-23 (IL-23), interleukin-12 (IL-12), and type I interferons (IFN), which are naturally occurring cytokines involved in inflammatory and immune responses. Deucravacitinib inhibits the release of proinflammatory cytokines and chemokines. |
| List of Excipients |
|---|
|
Tablet core: Hypromellose acetate succinate Film-coating: Polyvinyl alcohol |
Polyvinyl chloride/polychlorotrifluoroethylene (PVC/PCTFE) clear blister with push through aluminium foil containing 7 or 14 film-coated tablets per blister (calendar or non-calendar blisters).
Pack sizes: 7, 14, 28 and 84 film-coated tablets.
Not all pack sizes may be marketed.
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
EU/1/23/1718/001
EU/1/23/1718/002
EU/1/23/1718/003
EU/1/23/1718/004
EU/1/23/1718/005
EU/1/23/1718/006
EU/1/23/1718/007
EU/1/23/1718/008
| Drug | Countries | |
|---|---|---|
| SOTYKTU | Austria, Canada, Cyprus, Estonia, Finland, France, Croatia, Ireland, Italy, Japan, Lithuania, Romania, United Kingdom, United States |
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