Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Albireo AB, Arvid Wallgrens backe 20, 413 46 Göteborg, Sweden, e-mail: medinfo@albireopharma.com
Bylvay 200 micrograms hard capsules.
Bylvay 400 micrograms hard capsules.
Bylvay 600 micrograms hard capsules.
Bylvay 1 200 micrograms hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Bylvay 200 mcg hard capsules: Size 0 capsule (21.7 mm × 7.64 mm) with ivory opaque cap and white opaque body; imprinted “A200” with black ink. Bylvay 400 mcg hard capsules: Size 3 capsule (15.9 mm × 5.82 mm) with orange opaque cap and white opaque body; imprinted “A400” with black ink. Bylvay 600 mcg hard capsules: Size 0 capsule (21.7 mm × 7.64 mm) with ivory opaque cap and body; imprinted “A600” with black ink. Bylvay 1200 mcg hard capsules: Size 3 capsule (15.9 mm × 5.82 mm) with orange opaque cap and body; imprinted “A1200” with black ink. |
Bylvay 200 mcg hard capsules: Each hard capsule contains odevixibat sesquihydrate equivalent to 200 micrograms odevixibat.
Bylvay 400 mcg hard capsules: Each hard capsule contains odevixibat sesquihydrate equivalent to 400 micrograms odevixibat.
Bylvay 600 mcg hard capsules: Each hard capsule contains odevixibat sesquihydrate equivalent to 600 micrograms odevixibat.
Bylvay 1200 mcg hard capsules: Each hard capsule contains odevixibat sesquihydrate equivalent to 1 200 micrograms odevixibat.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Odevixibat |
Odevixibat is a reversible, potent, selective inhibitor of the ileal bile acid transporter (IBAT). Pharmacodynamic effects odevixibat acts locally in the distal ileum to decrease the reuptake of bile acids and increase the clearance of bile acids through the colon, reducing the concentration of bile acids in the serum. |
| List of Excipients |
|---|
|
Capsule content: Microcrystalline cellulose Capsule shell: Bylvay 200 mcg and 600 mcg hard capsules: Bylvay 400 mcg and 1200 mcg hard capsules: Printing ink: Shellac Ph.Eur |
High-density polyethylene (HDPE) bottle with a tamper evident, child resistant polypropylene closure.
Pack size: 30 hard capsules.
Albireo AB, Arvid Wallgrens backe 20, 413 46 Göteborg, Sweden, e-mail: medinfo@albireopharma.com
EU/1/21/1566/001
EU/1/21/1566/002
EU/1/21/1566/003
EU/1/21/1566/004
| Drug | Countries | |
|---|---|---|
| BYLVAY | Estonia, Croatia, Ireland, Israel, Lithuania, Poland, Romania |
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