Elzonris
tagraxofusp
Table of contents
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.
-
List item
Elzonris : EPAR - Medicine overview (PDF/113.74 KB)
First published: 25/01/2021
EMA/24814/2021 -
-
List item
Elzonris : EPAR - Risk-management-plan summary (PDF/135.07 KB)
First published: 25/01/2021
Last updated: 29/07/2022
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 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 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. |
Orphan |
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 |
6
|
Date of issue of marketing authorisation valid throughout the European Union |
07/01/2021
|
Contact address |
Basisweg 10 |
Product information
10/03/2023 Elzonris - EMEA/H/C/005031 - N/0022
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
News
-
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 November 202013/11/2020
-
18/09/2020
-
24/07/2020