Is Daratumumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Daratumumab, including DARZALEX 100 mg per 5 ml (20 mg/ml, Concentrate for solution for infusion, SAR 1816.60); DARZALEX 400 mg per 20 ml (20 mg/ml, Concentrate for solution for infusion, SAR 7266.50); Darzalex 1800 mg per 15 ml (1800 mg, Solution for injection, SAR 22518.90).

Is Daratumumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Daratumumab, including DARZALEX (Prescription).

Is Daratumumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Daratumumab: Darzalex.

Are there safety signals or safety updates for Daratumumab?

EMA PRAC: 3 entries; US FDA: 2 entries; MHRA: 1 entry (latest 2026-05-28).

Active substance

Daratumumab

SFDA 3
US FDA 1
EMA 1
Health Canada 3
Safety 6

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DARZALEX 100 mg per 5 ml	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 1816.60	Biological · Prescription	JANSSEN PHARMACEUTICA N.V	Valid
DARZALEX 400 mg per 20 ml	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 7266.50	Biological · Prescription	JANSSEN PHARMACEUTICA N.V	Valid
Darzalex 1800 mg per 15 ml	1800 mg	Solution for injection · Subcutaneous use	1 Vial	SAR 22518.90	Biological · Prescription	JANSSEN PHARMACEUTICA N.V	Valid

Indications — CHI Daman Drug Formulary

AMYLOIDOSIS - LIGHT CHAIN; MULTIPLE MYELOMA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
DARZALEX	100MG/5ML; 400MG/20ML	injectable · injection	JANSSEN BIOTECH	Prescription	16 Nov 2015

EMA European Union — centrally authorised medicines

Darzalex · Authorised · authorised 20 May 2016 · ATC L01FC01

Therapeutic indication (EMA)

Multiple Myeloma Darzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma. in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5.1). in as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. Smouldering multiple myeloma Darzalex as monotherapy is indicated for the treatment of adult patients with smouldering multiple myeloma at high risk of developing multiple myeloma. Light chain (AL) amyloidosis Darzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis. Darzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DARZALEX	02455951	100 MG / 5 ML	SOLUTION · INTRAVENOUS	JANSSEN INC
DARZALEX	02455978	400 MG / 20 ML	SOLUTION · INTRAVENOUS	JANSSEN INC
DARZALEX SC	02502712	1800 MG / 15 ML	SOLUTION · SUBCUTANEOUS	JANSSEN INC

Safety signals and safety-related labeling changes

US FDA 28 May 2026 DARZALEX — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 27 Jan 2026 DARZALEX FASPRO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 19 Aug 2019 Daratumumab (Darzalex▼): risk of reactivation of hepatitis B virus
Establish hepatitis B virus status before initiating daratumumab and in patients with unknown hepatitis B virus serology who are already being treated with daratumumab.
EMA PRAC 12 Apr 2018 PRAC signal: Encephalopathy
Action for MAH: update of the product information: No
EMA PRAC 30 Nov 2017 PRAC signal: Cytomegalovirus (CMV) reactivation
Action for MAH: update of the product information: No
EMA PRAC 1 Dec 2016 PRAC signal: Tumour lysis syndrome (TLS)
Action for MAH: update of the product information: No

All safety entries for daratumumab →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.