DARZALEX

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

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 about Daratumumab

Medication package inserts

Below package inserts are available for further reading:

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