Teriflunomide Mylan

Teriflunomide Mylan 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 Mylan 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 Mylan, 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 Mylan, 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 Mylan.

As for every medicine, the company provided studies on the quality of Teriflunomide Mylan. 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 Mylan 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 Mylan 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 Mylan outweigh the identified risks and it can be authorised for use in the EU.

The company that markets Teriflunomide Mylan 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 Mylan have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Teriflunomide Mylan are continuously monitored. Suspected side effects reported with Teriflunomide Mylan are carefully evaluated and any necessary action taken to protect patients.

Teriflunomide Mylan received a marketing authorisation valid throughout the EU on 9 November 2022.

This overview was last updated in 11-2022.