Sorafenib Accord
sorafenib
Table of contents
Overview
Sorafenib Accord is a cancer medicine used to treat patients who have the following diseases:
- hepatocellular carcinoma (a type of liver cancer);
- advanced renal cell carcinoma (a type of kidney cancer) when cancer treatment with interferon alpha or interleukin-2 has failed or cannot be used;
Sorafenib Accord contains the active substance sorafenib.
Sorafenib Accord is a ‘generic medicine’. This means that Sorafenib Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Nexavar. For more information on generic medicines, see the question-and-answer document here.
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Sorafenib Accord : EPAR - Medicine Overview (PDF/154.64 KB)
First published: 25/11/2022
EMA/781233/2022 -
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Sorafenib Accord : EPAR - Risk management plan summary (PDF/94.38 KB)
First published: 25/11/2022
Authorisation details
Product details | |
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Name |
Sorafenib Accord
|
Agency product number |
EMEA/H/C/005921
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Active substance |
Sorafenib tosilate
|
International non-proprietary name (INN) or common name |
sorafenib
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01EX02
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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 | |
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Marketing-authorisation holder |
Accord Healthcare S.L.U.
|
Date of issue of marketing authorisation valid throughout the European Union |
09/11/2022
|
Contact address |
Accord Healthcare S.L.U. |
Product information
Sorafenib Accord - EMEA/H/C/005921 -
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
Hepatocellular carcinoma
Sorafenib Accord is indicated for the treatment of hepatocellular carcinoma (see section 5.1).
Renal cell carcinoma
Sorafenib Accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.