Dasatinib Accordpharma

Withdrawn

This medicine's authorisation has been withdrawn

dasatinib (anhydrous)

Overview

On 25 March 2023, the European Commission withdrew the marketing authorisation for Dasatinib Accordpharma (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 Accordpharma 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 Accordpharma is a generic medicine of Sprycel. 

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Public Assessment Report (EPAR) for Dasatinib Accordpharma is updated to indicate that the marketing authorisation is no longer valid.

Dasatinib Accordpharma : EPAR - Medicine Overview

Reference Number: EMA/124603/2022

Dasatinib Accordpharma : EPAR - Risk management plan summary

Product information

Dasatinib Accordpharma : EPAR - Product Information

Dasatinib Accordpharma : EPAR - All authorised presentations

Product details

• Name of medicine:
  Dasatinib Accordpharma
• 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 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.

Authorisation details

• EMA product number:
  EMEA/H/C/005317
• 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 Accordpharma : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Dasatinib Accordpharma : EPAR - Public Assessment Report

Adopted Reference Number: EMA/117327/2022

CHMP summary of opinion for Dasatinib Accordpharma

Adopted Reference Number: EMA/CHMP/10901/2022