Dasatinib Accord

RSS

dasatinib (anhydrous)

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Dasatinib Accord has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 30/03/2023

Authorisation details

Product details
Name
Dasatinib Accord
Agency product number
EMEA/H/C/005446
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
GenericGeneric

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.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
24/03/2022
Contact address

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

Product information

08/06/2022 Dasatinib Accord - EMEA/H/C/005446 - IB/0001

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Select ‘available languages’ to access the language you need.

 

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 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.

Assessment history

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