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EMA Recommends Granting a Marketing Authorisation for Generic Dasatinib

Dasatinib Accord and Dasatinib Accordpharma are generic of Sprycel, which has been authorised in the EU since 2006
10 Feb 2022
Anticancer agents & Biologic therapy;  Haematologic malignancies

On 27 January 2022, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Dasatinib Accord, intended for the treatment of Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) and for the medicinal product Dasatinib Accordpharma, intended for the treatment of chronic myeloid leukaemia (CML) and Ph+ ALL.

The applicant for these medicinal products is Accord Healthcare S.L.U.

Dasatinib Accord and Dasatinib Accordpharma will be available as 20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg film-coated tablets. The active substance of Dasatinib Accord and Dasatinib Accordpharma is dasatinib, a protein kinase inhibitor (ATC code: L01EA02) that potently inhibits the activity of the BCR-ABL tyrosine kinase (TK) as well as several receptor TKs.

Dasatinib Accord and Dasatinib Accordpharma are generic of Sprycel, which has been authorised in the EU since 20 November 2006.

Studies have demonstrated the satisfactory quality of Dasatinib Accord and Dasatinib Accordpharma, and their bioequivalence to the reference product Sprycel.

The full indication for Dasatinib Accord is:

Dasatinib Accord is indicated for the treatment of adult patients with:

  • Ph+ 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.

The full indication for Dasatinib Accordpharma is:

Dasatinib Accordpharma is indicated for the treatment of adult patients with:

  • newly diagnosed Ph+ CML in the chronic phase
  • chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib.
  • Ph+ 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

Dasatinib Accord and Dasatinib Accordpharma should be prescribed by physicians experienced in the treatment of leukaemia.

Detailed recommendations for the use of these products will be described in the summary of product characteristics, which will be published in the European public assessment reports and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion. 

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