Atriance is a cancer medicine used to treat patients with T-cell acute lymphoblastic leukaemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL). These are types of cancer where T-lymphoblasts (a type of immature white blood cell) multiply too quickly. In T-ALL the abnormal cells are mainly in the blood and bone marrow, and in T-LBL they are mainly in the lymphatic system (lymph nodes or thymus gland). Atriance is used when the cancer has not responded to, or has stopped responding to, at least two types of chemotherapy.
Atriance contains the active substance nelarabine.
Atriance : EPAR - Medicine overview (PDF/123.14 KB)
First published: 20/09/2007
Last updated: 22/01/2020
Atriance : EPAR - Risk-management-plan summary (PDF/61.1 KB)
First published: 27/11/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
|Anatomical therapeutic chemical (ATC) code||
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.
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
30/10/2020 Atriance - EMEA/H/C/000752 - IB/0053
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
Due to the small patient populations in these disease settings, the information to support theseindications is based on limited data.