This is a summary of the European public assessment report (EPAR) for Atriance. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Atriance.
Atriance : EPAR - Summary for the public (PDF/79.79 KB)
First published: 20/09/2007
Last updated: 13/08/2015
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||
17/10/2019 Atriance - EMEA/H/C/000752 - II/0046/G
- 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.
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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.