TAKHZYRO

This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Spain, Turkey, UK.

Active ingredients

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

1	Lanadelumab UNII 2372V1TKXK - LANADELUMAB
	Lanadelumab is a fully human, monoclonal antibody (IgG1/κ-light chain). Lanadelumab inhibits active plasma kallikrein proteolytic activity. Lanadelumab provides sustained control of plasma kallikrein activity and thereby limits bradykinin generation in patients with HAE.
	Read more about Lanadelumab

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
TAKHZYRO Solution for injection	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
B06AC05		B Blood and blood forming organs → B06 Other hematological agents → B06A Other hematological agents → B06AC Drugs used in hereditary angioedema
Discover more medicines within B06AC05

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
BR	Câmara de Regulação do Mercado de Medicamentos	501121030038917
CA	Health Products and Food Branch	02480948, 02505614
EE	Ravimiamet	1783144, 1814037, 1814048, 1827367
ES	Centro de información online de medicamentos de la AEMPS	1181340004
FI	Lääkealan turvallisuus- ja kehittämiskeskus	122129
FR	Base de données publique des médicaments	61988861, 63473155
GB	Medicines & Healthcare Products Regulatory Agency	377339, 395164
HK	Department of Health Drug Office	67123
IE	Health Products Regulatory Authority	89097
IL	מִשְׂרַד הַבְּרִיאוּת	9116
IT	Agenzia del Farmaco	047417011, 047417023, 047417035, 047417047, 047417050, 047417062, 047417074, 047417086, 047417098
JP	医薬品医療機器総合機構	4490407G1023
LT	Valstybinė vaistų kontrolės tarnyba	1086746, 1089620, 1089621, 1091775, 1091776, 1091777
NL	Z-Index G-Standaard	16890698
NL	Z-Index G-Standaard, PRK	201618
NZ	Medicines and Medical Devices Safety Authority	20817
PL	Rejestru Produktów Leczniczych	100416826
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W68151001
TR	İlaç ve Tıbbi Cihaz Kurumu	8681429550530, 8681429550547, 8681429550554
US	FDA, National Drug Code	47783-644