Dasatinib Accord

RSS

dasatinib (anhydrous)

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

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.

This EPAR was last updated on 20/01/2023

Authorisation details

Product details
Name
Dasatinib Accord
Agency product number
EMEA/H/C/005446
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

Accord Healthcare S.L.U.
Edificio Este Planta 6a
World Trade Center
Moll De Barcelona S/n
08039 Barcelona
SPAIN

Product information

08/06/2022 Dasatinib Accord - EMEA/H/C/005446 - IB/0001

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Select ‘available languages’ to access the language you need.

 

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 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.

Assessment history

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