Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: BioCryst Ireland Limited, Block 4, Harcourt Centre, Harcourt Road, DUBLIN 2, D02HW77, Ireland
Orladeyo 150 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule (capsule). Capsule (19.4 mm × 6.9 mm) with white opaque body imprinted with “150” and light blue opaque cap imprinted with “BCX”. |
Each hard capsule contains 150 mg berotralstat (as dihydrochloride).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Berotralstat |
Berotralstat is an inhibitor of plasma kallikrein. In patients with hereditary angioedema (HAE) due to C1-INH deficiency or dysfunction, normal regulation of plasma kallikrein activity is impaired, which leads to uncontrolled increases in plasma kallikrein activity and bradykinin release, resulting in HAE attacks consisting of swelling (angioedema). |
| List of Excipients |
|---|
|
Capsule filling: Crospovidone (type A) Capsule shell: Gelatin Printing ink: Black iron oxide (E172) |
PCTFE/PVC-Alu blisters in a carton with 7 capsules per blister.
Pack size: 28 or 98 hard capsules.
BioCryst Ireland Limited, Block 4, Harcourt Centre, Harcourt Road, DUBLIN 2, D02HW77, Ireland
EU/1/21/1544/001
EU/1/21/1544/002
Date of first authorisation: 30 April 2021
| Drug | Countries | |
|---|---|---|
| ORLADEYO | Austria, Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
