Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Ipsen Pharma, 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
KAYFANDA 200 microgram hard capsules.
KAYFANDA 400 microgram hard capsules.
KAYFANDA 600 microgram hard capsules.
KAYFANDA 1 200 microgram hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. KAYFANDA 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. KAYFANDA 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. KAYFANDA 600 mcg hard capsules: Size 0 capsule (21.7 mm × 7.64 mm) with ivory opaque cap and body; imprinted “A600” with black ink. KAYFANDA 1 200 mcg hard capsules: Size 3 capsule (15.9 mm × 5.82 mm) with orange opaque cap and body; imprinted “A1200” with black ink. |
KAYFANDA 200 mcg hard capsules: Each hard capsule contains odevixibat sesquihydrate equivalent to 200 micrograms odevixibat.
KAYFANDA 400 mcg hard capsules: Each hard capsule contains odevixibat sesquihydrate equivalent to 400 micrograms odevixibat.
KAYFANDA 600 mcg hard capsules: Each hard capsule contains odevixibat sesquihydrate equivalent to 600 micrograms odevixibat.
KAYFANDA 1 200 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 |
|---|
|
Odevixibat is a reversible, potent, selective inhibitor of the ileal bile acid transporter (IBAT). 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. The extent of reduction of serum bile acids does not correlate with systemic PK. |
| List of Excipients |
|---|
|
Capsule content: Microcrystalline cellulose Capsule shell: KAYFANDA 200 mcg and 600 mcg hard capsules Hypromellose KAYFANDA 400 mcg and 1 200 mcg hard capsules Hypromellose Printing ink: Shellac |
High-density polyethylene (HDPE) bottle with a tamper evident, child resistant polypropylene closure.
Pack size: 30 hard capsules.
Ipsen Pharma, 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
EU/1/24/1854/001
EU/1/24/1854/002
EU/1/24/1854/003
EU/1/24/1854/004
Date of first authorisation: 19 September 2024
| Drug | Countries | |
|---|---|---|
| KAYFANDA | Austria, Estonia, France, Italy, Lithuania, Romania |
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