ORLADEYO

This brand name is authorized in Austria, Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland

Active ingredients

The drug ORLADEYO contains one active pharmaceutical ingredient (API):

1 Berotralstat UNII 88SH1NBL2B - BEROTRALSTAT HYDROCHLORIDE

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). Read about Berotralstat

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ORLADEYO Hard capsule	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
B06AC06		B Blood and blood forming organs → B06 Other hematological agents → B06A Other hematological agents → B06AC Drugs used in hereditary angioedema
Discover more medicines within B06AC06

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: EE	Ravimiamet	Identifier(s): 1847437, 1847448
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1211544001
Country: FR	Base de données publique des médicaments	Identifier(s): 66859849
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 9024, 9025
Country: IT	Agenzia del Farmaco	Identifier(s): 049480015, 049480027
Country: JP	医薬品医療機器総合機構	Identifier(s): 4490036M1020
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1092602, 1092603
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100455387