Human medicines European public assessment report (EPAR): Teriflunomide Accord, teriflunomide, Date of authorisation: 09/11/2022, Revision: 1, Status: Authorised
Overview
Teriflunomide Accord is a medicine used to treat patients from the age of 10 years with multiple sclerosis (MS), a disease in which inflammation attacks the protective covering (sheath) around nerves and damages the nerves themselves.
Teriflunomide Accord is used in the type of MS known as relapsing-remitting MS, when the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
Teriflunomide Accord is a ‘generic medicine’. This means that Teriflunomide Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Aubagio. For more information on generic medicines, see the question-and-answer document here.
Teriflunomide Accord contains the active substance teriflunomide.
Teriflunomide Accord can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the management of MS.
Teriflunomide Accord is available as tablets. The recommended dose for adults is 14 mg once a day. The dose for children depends on their body weight. For more information about using Teriflunomide Accord, see the package leaflet or contact your doctor or pharmacist.
In multiple sclerosis, the immune system (the body’s natural defences) incorrectly attacks the protective sheath around the nerves and the nerves themselves in the brain and spinal cord. The active substance in Teriflunomide Accord, teriflunomide, blocks an enzyme called ‘dihydroorotate dehydrogenase’ which is necessary for cells to multiply. The exact way teriflunomide works in MS is not known but it is thought to reduce the number of T-lymphocytes which form part of the immune system and are involved in the inflammation process. With fewer T-lymphocytes, there is less inflammation, helping to control the symptoms of MS.
Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Aubagio, and do not need to be repeated for Teriflunomide Accord.
As for every medicine, the company provided studies on the quality of Teriflunomide 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 Teriflunomide 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, Teriflunomide Accord has been shown to have comparable quality and to be bioequivalent to Aubagio. Therefore, the Agency’s view was that, as for Aubagio, the benefits of Teriflunomide Accord outweigh the identified risks and it can be authorised for use in the EU.
The company that markets Teriflunomide Accord must ensure that all healthcare professionals who are expected to prescribe this medicine receive educational material containing important safety information, including the tests and monitoring that should be carried out in patients before and after starting treatment. The company must also provide patient education cards with key safety information for patients.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Teriflunomide Accord have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Teriflunomide Accord are continuously monitored. Suspected side effects reported with Teriflunomide Accord are carefully evaluated and any necessary action taken to protect patients.
Teriflunomide Accord received a marketing authorisation valid throughout the EU on 09 November 2022.
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Product information
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Latest procedure affecting product information: N/0004
15/04/2024
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).
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Product details
- Name of medicine
Teriflunomide Accord
- Active substance
Teriflunomide
- International non-proprietary name (INN) or common name
teriflunomide
- Therapeutic area (MeSH)
Multiple Sclerosis, Relapsing-Remitting
- Anatomical therapeutic chemical (ATC) code
L04AA31
Pharmacotherapeutic group
- Immunosuppressants
- Selective immunosuppressants
Therapeutic indication
Teriflunomide Accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).
More information on Teriflunomide Accord
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