Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Brussels, Belgium
Velsipity 2 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Green, round, film-coated tablet of approximately 6 mm diameter, debossed with “ETR” on one side and “2” on the other side. |
Each film-coated tablet contains etrasimod arginine equivalent to 2 mg etrasimod.
Excipient with known effect: Each film-coated tablet contains 0.0156 mg of the colouring agent tartrazine (E102).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Etrasimod |
Etrasimod is a sphingosine-1-phosphate (S1P) receptor modulator that binds to S1P receptors 1, 4 and 5 (S1P1,4,5) and is a balanced G-protein and beta-arrestin agonist at S1P1. Etrasimod has minimal activity on S1P3 and no activity on S1P2. Etrasimod partially and reversibly blocks the capacity of lymphocytes to egress from lymphoid organs, reducing the number of lymphocytes in peripheral blood thereby lowering the number of activated lymphocytes in the tissue. The mechanism by which etrasimod exerts therapeutic effects in ulcerative colitis is unknown but may involve the reduction of lymphocyte migration into sites of inflammation. |
| List of Excipients |
|---|
|
Tablet core: Magnesium stearate (E470b) Tablet coating: Brilliant blue FCF aluminium lake (E133) |
High-density polyethylene (HDPE) bottle closed with a polypropylene cap, desiccant integrated directly into the cap. Pack size of 30 film-coated tablets.
Aluminium blister strip laminated to an oriented polyamine (oPA) film and integrated desiccant layer (HDPE/LDPE), with a paper/aluminium/LDPE backing. Pack size of 28 or 98 film-coated tablets.
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Brussels, Belgium
EU/1/23/1790/001
EU/1/23/1790/002
EU/1/23/1790/003
| Drug | Countries | |
|---|---|---|
| VELSIPITY | Austria, Canada, Estonia, France, Croatia, Ireland, Italy, Lithuania, United States |
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