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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 is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
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.
Sandoz Pharmaceuticals d.d.
|Date of issue of marketing authorisation valid throughout the European Union||
Verovškova ulica 57
16/01/2023 Atriance - EMEA/H/C/000752 - N/0061
This medicine’s product information is available in all official EU languages.
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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.
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 these indications is based on limited data.