Dasatinib Accordpharma

Withdrawn

This medicine's authorisation has been withdrawn

dasatinib (anhydrous)

Overview

The marketing authorisation for Dasatinib Accordpharma has been withdrawn at the request of the marketing-authorisation holder.

Dasatinib Accordpharma : EPAR - Medicine Overview

Reference Number: EMA/124603/2022

Dasatinib Accordpharma : EPAR - Risk management plan summary

Product information

Dasatinib Accordpharma : EPAR - Product Information

Latest procedure affecting product information: IB/0001

22/06/2022

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Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

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

AdoptedReference Number: EMA/117327/2022

CHMP summary of opinion for Dasatinib Accordpharma

AdoptedReference Number: EMA/CHMP/10901/2022