Basic Information
L01EX02
sorafenib
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.
Overview Summary
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.
Active Substances (1)
Sorafenib tosilate
Documents (10)
Sorafenib Accord : EPAR - Product Information
November 25, 2022
DRUG_PRODUCT_INFORMATION
Sorafenib Accord : EPAR - Public assessment report
November 25, 2022
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Sorafenib Accord
September 16, 2022
CHANGES_SINCE_INITIAL_AUTHORISATION
Sorafenib Accord : EPAR - Risk management plan summary
November 25, 2022
RISK_MANAGEMENT_PLAN_SUMMARY
Sorafenib Accord : EPAR - All authorised presentations
November 25, 2022
AUTHORISED_PRESENTATIONS
Sorafenib Accord : EPAR - Public assessment report
November 25, 2022
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
CHMP summary of positive opinion for Sorafenib Accord
September 16, 2022
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Sorafenib Accord : EPAR - Procedural steps taken and scientific information after authorisation (archive)
April 3, 2024
CHANGES_SINCE_INITIAL_AUTHORISATION
Sorafenib Accord : EPAR - Medicine Overview
November 25, 2022
OVERVIEW_DOCUMENT
Sorafenib Accord : EPAR - Procedural steps taken and scientific information after authorisation
May 27, 2025
CHANGES_SINCE_INITIAL_AUTHORISATION
Overview Q&A (7)
Question
How is Sorafenib Accord used?
Answer
Sorafenib Accord can only be obtained with a prescription. Treatment with Sorafenib Accord should be supervised by doctors who have experience in using cancer treatments.
Sorafenib Accord is given as two tablets twice a day, without food or with a meal that has a low or moderate fat content. Treatment should continue as long as the patient continues to benefit from it without too many side effects. To manage side effects, treatment may be temporarily interrupted or the dose may be reduced.
For more information about using Sorafenib Accord, see the package leaflet or contact your doctor or pharmacist.
Question
How does Sorafenib Accord work?
Answer
The active substance in Sorafenib Accord, sorafenib, is a protein kinase inhibitor. This means that it blocks some specific enzymes known as protein kinases that are involved in the growth and spread of cancer cells, as well as in the development of new blood vessels supplying the tumours. By blocking these enzymes, Sorafenib Accord can reduce the growth of cancer cells and cut off the blood supply that keeps them growing.
Question
Why is Sorafenib Accord authorised in the EU?
Answer
The European Medicines Agency concluded that, in accordance with EU requirements, Sorafenib Accord has been shown to have comparable quality and to be bioequivalent to Nexavar. Therefore, the Agency’s view was that, as for Nexavar, the benefits of Sorafenib Accord outweigh the identified risks and it can be authorised for use in the EU.
Question
What measures are being taken to ensure the safe and effective use of Sorafenib Accord?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sorafenib Accord have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Sorafenib Accord are continuously monitored. Suspected side effects reported with Sorafenib Accord are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Sorafenib Accord
Answer
Sorafenib Accord received a marketing authorisation valid throughout the EU on 9 November 2022.
Question
What are the benefits and risks of Sorafenib Accord?
Answer
Because Sorafenib Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Question
How has Sorafenib Accord been studied?
Answer
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Nexavar, and do not need to be repeated for Sorafenib Accord.
As for every medicine, the company provided studies on the quality of Sorafenib Accord. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.