Dasatinib Accordpharma
dasatinib (anhydrous)
Table of contents
Overview
The marketing authorisation for Dasatinib Accordpharma has been withdrawn at the request of the marketing-authorisation holder.
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Dasatinib Accordpharma : EPAR - Medicine Overview (PDF/758.43 KB)
First published: 30/03/2022
Last updated: 30/03/2023
EMA/124603/2022 -
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Dasatinib Accordpharma : EPAR - Risk management plan summary (PDF/701.15 KB)
First published: 30/03/2022
Last updated: 30/03/2023
Authorisation details
| Product details | |
|---|---|
| Name |
Dasatinib Accordpharma
|
| Agency product number |
EMEA/H/C/005317
|
| Active substance |
dasatinib
|
| International non-proprietary name (INN) or common name |
dasatinib (anhydrous)
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
L01EA02
|
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. |
| 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. |
Product information
22/06/2022 Dasatinib Accordpharma - EMEA/H/C/005317 - IB/0001
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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).
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 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.