Dasatinib Accord

Withdrawn

This medicine's authorisation has been withdrawn

dasatinib (anhydrous)

Overview

On 25 March 2023, the European Commission withdrew the marketing authorisation for Dasatinib Accord (dasatinib) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Accord Healthcare S.L.U., which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Dasatinib Accord was granted marketing authorisation in the EU on 24 March 2022 for the treatment of leukaemia. The product had not been marketed in the EU. Dasatinib Accord is a generic medicine of Sprycel. 

The European Public Assessment Report (EPAR) for Dasatinib Accord is updated to indicate that the marketing authorisation is no longer valid.

Dasatinib Accord : EPAR - Medicine Overview

Reference Number: EMA/124586/2022

Dasatinib Accord : EPAR - Risk management plan summary

Product information

Dasatinib Accord : EPAR - Product Information

Dasatinib Accord : EPAR - All authorised presentations

Product details

• Name of medicine:
  Dasatinib Accord
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/005446
• 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.

• Marketing authorisation holder:
  Accord Healthcare S.L.U.

  Edificio Este Planta 6a; World Trade Center; Moll De Barcelona S/n; 08039 Barcelona; SPAIN

• Opinion adopted:
  27/01/2022
• Marketing authorisation issued:
  24/03/2022
• Revision:
  1

Assessment history

Changes since initial authorisation of medicine

Dasatinib Accord : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Dasatinib Accord : EPAR - Public Assessment Report

AdoptedReference Number: EMA/116969/2022

CHMP summary of opinion for Dasatinib Accord

AdoptedReference Number: EMA/CHMP/10836/2022