Dasatinib Accordpharma
dasatinib (anhydrous)
Table of contents
Overview
Dasatinib Accordpharma is a cancer medicine. It is used to treat adults with the following types of leukaemia (cancer of the white blood cells):
- chronic myeloid leukaemia (CML) in the ‘chronic’ phase in newly diagnosed patients who are ‘Philadelphia chromosome positive’ (Ph+). In CML, granulocytes (a type of white blood cell) start growing out of control. 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;
- CML in ‘chronic’, ‘accelerated’ and ‘blast’ phases. Dasatinib Accordpharma is used when other treatments including imatinib (another cancer medicine) do not work or cause troublesome side effects;
- Ph+ acute lymphoblastic leukaemia (ALL), where lymphocytes (another type of white blood cell) multiply too quickly and live for too long, or in ‘lymphoid blast’ CML. Dasatinib Accordpharma is used when other treatments do not work or cause troublesome side effects.
Dasatinib Accordpharma is also used in children to treat:
- newly diagnosed Ph+ CML in the ‘chronic’ phase, or Ph+ CML when other treatments including imatinib cannot be given or have not worked;
- newly diagnosed Ph+ ALL in combination with chemotherapy (cancer medicines).
Dasatinib Accordpharma contains the active substance dasatinib and is a ‘generic medicine’. This means that Dasatinib Accordpharma 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.
-
List item
Dasatinib Accordpharma : EPAR - Medicine Overview (PDF/167.19 KB)
First published: 30/03/2022
EMA/124603/2022 -
-
List item
Dasatinib Accordpharma : EPAR - Risk management plan summary (PDF/114.18 KB)
First published: 30/03/2022
Authorisation details
| Product details | |
|---|---|
| Name |
Dasatinib Accordpharma
|
| Agency product number |
EMEA/H/C/005317
|
| Active substance |
dasatinib
|
| 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 | |
|---|---|
| Marketing-authorisation holder |
Accord Healthcare S.L.U.
|
| Revision |
1
|
| Date of issue of marketing authorisation valid throughout the European Union |
24/03/2022
|
| Contact address |
World Trade Center |
Product information
22/06/2022 Dasatinib Accordpharma - EMEA/H/C/005317 - 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 Accordpharma is indicated for the treatment of adult patients with:
newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase.
chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib.
Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.
Dasatinib Accordpharma is indicated for the treatment of paediatric patients with:
newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.
newly diagnosed Ph+ ALL in combination with chemotherapy.