Dasatinib Accordpharma


dasatinib (anhydrous)

This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Dasatinib Accordpharma has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 30/03/2023

Authorisation details

Product details
Dasatinib Accordpharma
Agency product number
Active substance
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

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.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

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

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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