Sorafenib Accord

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sorafenib

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 25/11/2022

Authorisation details

Product details
Name
Sorafenib Accord
Agency product number
EMEA/H/C/005921
Active substance
Sorafenib tosilate
International non-proprietary name (INN) or common name
sorafenib
Therapeutic area (MeSH)
  • Carcinoma, Hepatocellular
  • Carcinoma, Renal Cell
Anatomical therapeutic chemical (ATC) code
L01EX02
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.
Date of issue of marketing authorisation valid throughout the European Union
09/11/2022
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

Sorafenib Accord - EMEA/H/C/005921 -

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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

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.

Assessment history

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