Elzonris

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tagraxofusp

Authorised
This medicine is authorised for use in the European Union.

Overview

Elzonris is a medicine used to treat adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a type of blood cancer which can affect many organs including the skin, the bone marrow (the spongy tissue inside the large bones) and the lymph nodes.

BPDCN is rare, and Elzonris was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 11 November 2015.

This EPAR was last updated on 23/09/2022

Authorisation details

Product details
Name
Elzonris
Agency product number
EMEA/H/C/005031
Active substance
tagraxofusp
International non-proprietary name (INN) or common name
tagraxofusp
Therapeutic area (MeSH)
Lymphoma
Anatomical therapeutic chemical (ATC) code
L01XX67
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Exceptional circumstancesExceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Stemline Therapeutics B.V.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
07/01/2021
Contact address

Basisweg 10
1043 AP Amsterdam 
Netherlands

Product information

22/09/2022 Elzonris - EMEA/H/C/005031 - IA/0017

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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

Assessment history

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