Sorafenib Accord
Authorised
This medicine is authorised for use in the European Union
sorafenib
MedicineHumanAuthorised
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.
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.
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.
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.
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.
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.
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.
Sorafenib Accord received a marketing authorisation valid throughout the EU on 9 November 2022.
Product information
Latest procedure affecting product information: N/0001
27/03/2024
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).
Product details
- Name of medicine
- Sorafenib Accord
- 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
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic 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.
News on Sorafenib Accord
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