Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Vifor Fresenius Medical Care Renal Pharma France, 100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France
Tavneos 10 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Capsules with yellow body and light orange cap with “CCX168” in black ink. One capsule has a length of 22 mm and a diameter of 8 mm (size 0). |
Each hard capsule contains 10 mg of avacopan.
Excipient with known effect: Each hard capsule contains 245 mg of macrogolglycerol hydroxystearate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Avacopan |
Avacopan is a selective antagonist of the human complement 5a receptor (C5aR1 or CD88) and competitively inhibits the interaction between C5aR1 and the anaphylatoxin C5a. The specific and selective blockade of C5aR1 by avacopan reduces the pro-inflammatory effects of C5a, which include neutrophil activation, migration, and adherence to sites of small blood vessel inflammation, vascular endothelial cell retraction and permeability. |
| List of Excipients |
|---|
|
Capsule content: Macrogolglycerol hydroxystearate Capsule shell: Gelatin Imprinting ink: Black iron oxide (E172) |
High density polyethylene (HDPE) bottle with child-resistant closure and induction seal.
Pack sizes of 30 or 180 hard capsules.
Not all pack sizes may be marketed.
Vifor Fresenius Medical Care Renal Pharma France, 100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France
EU/1/21/1605/001
EU/1/21/1605/002
| Drug | Countries | |
|---|---|---|
| TAVNEOS | Austria, Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland |
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