Is Tafasitamab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Tafasitamab, including Minjuvi (200 mg, Powder for concentrate for solution for infusion, SAR 3501.40).

Is Tafasitamab approved by the US FDA?

Drugs@FDA lists 1 application product line for Tafasitamab, including MONJUVI (Prescription).

Is Tafasitamab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tafasitamab: Minjuvi.

Are there safety signals or safety updates for Tafasitamab?

US FDA: 2 entries (latest 2025-06-18).

Active substance

Tafasitamab

SFDA 1
US FDA 1
EMA 1
Health Canada 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Minjuvi	200 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 3501.40	Biological · Prescription	Incyte Biosciences International Sarl	Valid

Indications — CHI Daman Drug Formulary

DIFFUSE LARGE B CELL LYMPHOMA; FOLLICULAR LYMPHOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
MONJUVI	12MG/KG	solution · intravenous	MORPHOSYS US INC	Prescription	31 Jul 2020

EMA European Union — centrally authorised medicines

Minjuvi Incyte Biosciences Distribution B.V. · Authorised · authorised 26 Aug 2021 · ATC L01FX12

Therapeutic indication (EMA)

Minjuvi is indicated in combination with lenalidomide followed by Minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
MINJUVI	02518627	200 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	INCYTE CORPORATION

Safety signals and safety-related labeling changes

US FDA 18 Jun 2025 MONJUVI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 2 Jun 2021 Monjuvi (tafasitamab-cxix) for injection — safety-related labeling change
Labeling sections changed: Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for tafasitamab →

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.