Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: BioCryst Ireland Limited, Block 4, Harcourt Centre, Harcourt Road, DUBLIN 2, D02HW77, Ireland
Orladeyo 72 mg film-coated granules in sachet.
Orladeyo 96 mg film-coated granules in sachet.
Orladeyo 108 mg film-coated granules in sachet.
Orladeyo 132 mg film-coated granules in sachet.
| Pharmaceutical Form |
|---|
|
Film-coated granules in sachet. White to off-white, plain-faced, round film-coated granules, approximately 2 mm in diameter. |
Orladeyo 72 mg film-coated granules in sachet: Each sachet contains 72 mg berotralstat (as dihydrochloride).
Orladeyo 96 mg film-coated granules in sachet: Each sachet contains 96 mg berotralstat (as dihydrochloride).
Orladeyo 108 mg film-coated granules in sachet: Each sachet contains 108 mg berotralstat (as dihydrochloride).
Orladeyo 132 mg film-coated granules in sachet: Each sachet contains 132 mg berotralstat (as dihydrochloride).
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
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 |
|---|
|
Granule core: Crospovidone (type A) Granule coating: Butylated methacrylate copolymer, basic (E1205) |
PET/AL/PE foil laminate sachets.
Pack size: 28 sachets (each carton contains 4 wallets with 7 sachets each).
BioCryst Ireland Limited, Block 4, Harcourt Centre, Harcourt Road, DUBLIN 2, D02HW77, Ireland
EU/1/21/1544/003
EU/1/21/1544/004
EU/1/21/1544/005
EU/1/21/1544/006
Date of first authorisation: 30 April 2021
Date of latest renewal: 12 February 2026
| Drug | Countries | |
|---|---|---|
| ORLADEYO | Austria, Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland |
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