Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Ipsen Pharma, 65 quai George Gorse, 92100 Boulogne-Billancourt, France
Iqirvo 80 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). The tablets are round, orange, approximately 8 mm diameter, debossed with ‘ELA 80’ on one side. |
Each film-coated tablet contains 80 mg of elafibranor.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Elafibranor |
Elafibranor and its main active metabolite GFT1007 are dual peroxisome proliferator-activated receptor (PPAR)α/δ agonists. PPAR α/δ are thought to be key regulators of bile acid (BA) homeostasis, inflammation and fibrosis. Activation of PPARα and PPARδ decreases bile toxicity and improve cholestasis by modulating BA synthesis, detoxification and transporters. Activation of PPARα and PPARδ also has anti-inflammatory effects by acting on different pathways. |
| List of Excipients |
|---|
|
Tablet content: Microcrystalline cellulose Film-coating: Polyvinyl alcohol-part hydrolysed |
40 mL high-density polyethylene (HDPE) bottle with a polypropylene child-resistant screw cap.
Each bottle contains 30 film-coated tablets.
Ipsen Pharma, 65 quai George Gorse, 92100 Boulogne-Billancourt, France
EU/1/24/1855/001
| Drug | Countries | |
|---|---|---|
| IQIRVO | United States |
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