DARZALEX

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

Active ingredients

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

1	Daratumumab UNII 4Z63YK6E0E - DARATUMUMAB
	Daratumumab is an IgG1κ human monoclonal antibody (mAb) that binds to the CD38 protein expressed at a high level on the surface of multiple myeloma tumour cells, as well as other cell types and tissues at various levels. CD38 protein has multiple functions such as receptor mediated adhesion, signalling and enzymatic activity. Daratumumab has been shown to potently inhibit the in vivo growth of CD38-expressing tumour cells.
	Read more about Daratumumab

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
DARZALEX Concentrate for solution for infusion	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
L01FC01	Daratumumab	L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FC CD38 (Clusters of Differentiation 38) inhibitors
Discover more medicines within L01FC01

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
AU	Pharmaceutical Benefits Scheme	12220E, 12221F, 12225K, 12226L, 12228N, 12229P, 12230Q, 12231R
CA	Health Products and Food Branch	02455951, 02455978, 02502712
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	159-MBE-0720, 242-MBE-1222
EE	Ravimiamet	1719086, 1719097, 1799152, 1799163, 1799231, 1824735
ES	Centro de información online de medicamentos de la AEMPS	1161101001, 1161101001IP, 1161101002, 1161101002IP, 1161101004, 1161101004IP
FI	Lääkealan turvallisuus- ja kehittämiskeskus	149279, 493534, 509806
FR	Base de données publique des médicaments	60047225, 67352140
GB	Medicines & Healthcare Products Regulatory Agency	328875, 328879, 386999
HK	Department of Health Drug Office	65066, 65067, 65068
IL	מִשְׂרַד הַבְּרִיאוּת	7807, 7808, 8897
JP	医薬品医療機器総合機構	4291437A1028, 4291437A2024
LT	Valstybinė vaistų kontrolės tarnyba	1080380, 1080381, 1090531, 1090532
NL	Z-Index G-Standaard, PRK	139408, 139416, 204242
NZ	Medicines and Medical Devices Safety Authority	18792, 18870, 21045
PL	Rejestru Produktów Leczniczych	100370449, 100437751
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W62902001, W62902002, W66768001
SG	Health Sciences Authority	15110P, 15111P
TN	Direction de la Pharmacie et du Médicament	15273061H, 15273062H
TR	İlaç ve Tıbbi Cihaz Kurumu	8699593760020, 8699593760037, 8699593775154
US	FDA, National Drug Code	57894-502