ORLADEYO

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

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 more about Berotralstat

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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