MedPath
EMA Approval

Teriflunomide Mylan

Teriflunomide Viatris (previously Teriflunomide Mylan)

L04AA31

xl 04 aa 31

Immunosuppressants

teriflunomide

Multiple Sclerosis, Relapsing-Remitting

Basic Information

L04AA31

xl 04 aa 31

Immunosuppressants

Therapeutic indication

Teriflunomide Mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 of the SmPC for important information on the population for which efficacy has been established).

Overview Summary

Teriflunomide Viatris 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 Viatris 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 Viatris contains the active substance teriflunomide and is a ‘generic medicine’. This means that Teriflunomide Viatris 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.

Authorisations (1)

EMEA/H/C/005962

Viatris Limited,Damastown Industrial Park,Mulhuddart,Dublin,Dublin 15,Ireland

Authorised

November 9, 2022

Active Substances (2)

Teriflunomide

Teriflunomide

Documents (14)

Teriflunomide Mylan : EPAR - Product Information

November 22, 2022

DRUG_PRODUCT_INFORMATION

Teriflunomide Mylan : EPAR - All Authorised Presentations

November 22, 2022

AUTHORISED_PRESENTATIONS

Teriflunomide Mylan : EPAR - Procedural steps taken and scientific information after authorisation

January 16, 2023

CHANGES_SINCE_INITIAL_AUTHORISATION

Teriflunomide Mylan : EPAR - Risk management plan summary

November 22, 2022

RISK_MANAGEMENT_PLAN_SUMMARY

Teriflunomide Mylan : EPAR - Public Assessment Report

November 22, 2022

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

CHMP summary of positive opinion for Teriflunomide Mylan

September 16, 2022

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Teriflunomide Mylan : EPAR - Medicine overview

November 22, 2022

OVERVIEW_DOCUMENT

Teriflunomide Viatris : EPAR - Medicine overview

November 22, 2022

OVERVIEW_DOCUMENT

Teriflunomide Viatris : EPAR - Product information

November 22, 2022

DRUG_PRODUCT_INFORMATION

Teriflunomide Viatris : EPAR - All authorised presentations

November 22, 2022

AUTHORISED_PRESENTATIONS

Teriflunomide Viatris : EPAR - Procedural steps taken and scientific information after authorisation

January 16, 2023

CHANGES_SINCE_INITIAL_AUTHORISATION

Teriflunomide Mylan : EPAR - Public Assessment Report

November 22, 2022

CHANGES_SINCE_INITIAL_AUTHORISATION

CHMP summary of positive opinion for Teriflunomide Mylan

September 16, 2022

CHANGES_SINCE_INITIAL_AUTHORISATION

Teriflunomide Mylan-H-C-PSUSA-00010135-202309 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

July 24, 2024

CHANGES_SINCE_INITIAL_AUTHORISATION

Overview Q&A (14)

Question

What are the benefits and risks of Teriflunomide Mylan?

Answer

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.

Question

Other information about Teriflunomide Viatris

Answer

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

The name of the medicine was changed to Teriflunomide Viatris on 15 October 2024.

Question

What are the benefits and risks of Teriflunomide Viatris?

Answer

Because Teriflunomide Viatris 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 is Teriflunomide Mylan used?

Answer

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.

Question

How does Teriflunomide Mylan work?

Answer

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.

Question

Why is Teriflunomide Mylan authorised in the EU?

Answer

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.

Question

What measures are being taken to ensure the safe and effective use of Teriflunomide Mylan?

Answer

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.

Question

Other information about Teriflunomide Mylan

Answer

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

This overview was last updated in 11-2022.

Question

How has Teriflunomide Mylan been studied?

Answer

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.

Question

Why is Teriflunomide Viatris authorised in the EU?

Answer

The European Medicines Agency concluded that, in accordance with EU requirements, Teriflunomide Viatris 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 Viatris outweigh the identified risks and it can be authorised for use in the EU.

Question

How does Teriflunomide Viatris work?

Answer

In multiple sclerosis, the immune system (the body’s natural defences) attacks the protective sheath around the nerves and the nerves themselves in the brain and spinal cord. The active substance in Teriflunomide Viatris, 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.

Question

How is Teriflunomide Viatris used?

Answer

Teriflunomide Viatris 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 Viatris is available as tablets to be taken once a day.

For more information about using Teriflunomide Viatris, see the package leaflet or contact your doctor or pharmacist.

Question

How has Teriflunomide Viatris been studied?

Answer

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 Viatris.

As for every medicine, the company provided studies on the quality of Teriflunomide Viatris. 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.

Question

What measures are being taken to ensure the safe and effective use of Teriflunomide Viatris?

Answer

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Teriflunomide Viatris have also been included in the summary of product characteristics and the package leaflet. Any additional measures in place for Aubagio, such as educational material for healthcare professionals and a patient card with key safety information, also apply to Teriflunomide Viatris where appropriate.

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

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