Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Vifor France, 100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France
Filspari 200 mg film-coated tablets.
Filspari 400 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Filspari 200 mg film-coated tablets: White to off-white, oval‒shaped, film-coated tablet, debossed with “105” on one side and plain on the other side. The dimensions of the tablets are approximately 13 mm × 7 mm. Filspari 400 mg film-coated tablets: White to off-white, oval‒shaped, film-coated tablet, debossed with “021” on one side and plain on the other side. The dimensions of the tablets are approximately 18 mm × 8 mm. |
Each tablet contains 200 mg of sparsentan.
Excipient with known effect: Each tablet contains 42 mg of lactose.
Each tablet contains 400 mg of sparsentan.
Excipient with known effect: Each tablet contains 84 mg of lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sparsentan |
Sparsentan is a dual endothelin angiotensin receptor antagonist. It is a single molecule that functions as a high affinity, dual-acting antagonist of both the ETAR and AT1R. Endothelin 1, via ETAR, and angiotensin II, via AT1R, mediate processes that lead to IgAN progression through haemodynamic actions and mesangial cell proliferation, increased expression and activity of proinflammatory and profibrotic mediators, podocyte injury, and oxidative stress. Sparsentan inhibits activation of both ETAR and AT1R and thereby reduces proteinuria and slows the progression of kidney disease. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose Film coating: Poly(vinyl alcohol) |
High-density polyethylene (HDPE) bottle with child-resistant polypropylene cap.
Pack size of 30 film-coated tablets.
Vifor France, 100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France
EU/1/23/1788/001
EU/1/23/1788/002
| Drug | Countries | |
|---|---|---|
| FILSPARI | France, Lithuania, United States |
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