Dasatinib Accordpharma

RSS

dasatinib (anhydrous)

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 24/10/2022

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)
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Anatomical therapeutic chemical (ATC) code
L01EA02
GenericGeneric

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
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

22/06/2022 Dasatinib Accordpharma - EMEA/H/C/005317 - IB/0001

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Product information documents contain:

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.

Assessment history

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