Is Tagraxofusp 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 Tagraxofusp, including ELZONRIS (1000 µ/ml, Injection, SAR 105008.35).

Is Tagraxofusp approved by the US FDA?

Drugs@FDA lists 1 application product line for Tagraxofusp, including ELZONRIS (Prescription).

Is Tagraxofusp authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tagraxofusp: Elzonris.

Are there safety signals or safety updates for Tagraxofusp?

US FDA: 1 entry (latest 2023-07-26).

Active substance

Tagraxofusp

SFDA 1
US FDA 1
EMA 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ELZONRIS	1000 µ/ml	Injection · Intravenous use	1 Vial	SAR 105008.35	Biological · Prescription	Stemline Therapeutics, Inc	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
ELZONRIS	1000MCG	solution · injection	STEMLINE THERAPEUTICS INC	Prescription	21 Dec 2018

EMA European Union — centrally authorised medicines

Elzonris Stemline Therapeutics B.V. · Authorised · authorised 7 Jan 2021 · ATC L01XX67

Therapeutic indication (EMA)

Elzonris is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Safety signals and safety-related labeling changes

US FDA 26 Jul 2023 ELZONRIS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations

All safety entries for tagraxofusp →

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.