This is a summary of the European public assessment report (EPAR) for Imatinib Accord. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Imatinib Accord.
For practical information about using Imatinib Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Imatinib Accord : EPAR - Summary for the public (PDF/89.84 KB)Adopted
First published: 10/07/2013
Last updated: 19/07/2017
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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.
Accord Healthcare S.L.U.
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World Trade Center
23/06/2022 Imatinib Accord - EMEA/H/C/002681 - IB/0035/G
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.
Imatinib Accord is indicated for the treatment of
- the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).