Sorafenib Accord

sorafenib

Table of contents

Opinion

On 15 September 2022, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Sorafenib Accord, intended for the treatment of hepatocellular carcinoma and renal cell carcinoma. The applicant for this medicinal product is Accord Healthcare S.L.U.

Sorafenib Accord will be available as a 200 mg film-coated tablet. The active substance of Sorafenib Accord is sorafenib, a protein kinase inhibitor (ATC code: L01EX02). It inhibits the activity of targets present in tumour cells and in the tumour vasculature.

Sorafenib Accord is a generic of Nexavar, which has been authorised in the EU since 19 July 2006. Studies have demonstrated the satisfactory quality of Sorafenib Accord and its bioequivalence to the reference product Nexavar. 

The full indication is:

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.

Sorafenib Accord should be prescribed by a physician experienced in the treatment of cancer.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Key facts

Name
Sorafenib Accord
Agency product number
EMEA/H/C/005921
International non-proprietary name (INN) or common name
  • sorafenib
Active substance
  • Sorafenib tosilate
Therapeutic area
Carcinoma, Hepatocellular
Carcinoma, Renal Cell
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.

Date opinion adopted
15/09/2022
Company name
Accord Healthcare S.L.U.
Status
Positive
Application type
Initial authorisation

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