Dasatinib Accord
dasatinib (anhydrous)
Table of contents
Overview
Dasatinib Accord is a cancer medicine. It is used to treat ‘Philadelphia chromosome positive’ (Ph+) acute lymphoblastic leukaemia (ALL) in adults when other treatments do not work or cause troublesome side effects. It is also used in children with newly diagnosed Ph+ ALL in combination with chemotherapy (cancer medicines).
Ph+ ALL is a cancer of lymphocytes (a type of white blood cells). In this disease, the lymphocytes multiply too quickly and live for too long. Ph+ means that some of the patient’s genes have rearranged themselves to form a special chromosome called the Philadelphia chromosome which produces an enzyme, Bcr-Abl kinase, that leads to the development of leukaemia.
Dasatinib Accord contains the active substance dasatinib and is a ‘generic medicine’. This means that Dasatinib Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Sprycel. For more information on generic medicines, see the question-and-answer document here.
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Dasatinib Accord : EPAR - Medicine Overview (PDF/146.31 KB)
First published: 30/03/2022
EMA/124586/2022 -
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Dasatinib Accord : EPAR - Risk management plan summary (PDF/114.18 KB)
First published: 30/03/2022
Authorisation details
Product details | |
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Name |
Dasatinib Accord
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Agency product number |
EMEA/H/C/005446
|
Active substance |
dasatinib
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International non-proprietary name (INN) or common name |
dasatinib (anhydrous)
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01EA02
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
Publication details | |
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Marketing-authorisation holder |
Accord Healthcare S.L.U.
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Revision |
1
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Date of issue of marketing authorisation valid throughout the European Union |
24/03/2022
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Contact address |
Accord Healthcare S.L.U. |
Product information
08/06/2022 Dasatinib Accord - EMEA/H/C/005446 - IB/0001
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
Dasatinib Accord is indicated for the treatment of adult patients with:
• Ph+ acute lymphoblastic leukaemia (ALL) with resistance or intolerance to prior therapy.
Dasatinib Accord is indicated for the treatment of paediatric patients with:
• newly diagnosed Ph+ ALL in combination with chemotherapy.