Basic Information
Teriflunomide Viatris (previously Teriflunomide Mylan)
Regulatory Information
EMEA/H/C/005962
November 9, 2022
September 15, 2022
5
January 28, 2025
Company Information
Ireland
Damastown Industrial Park Mulhuddart Dublin Dublin 15
VIATRIS PHARMA LIMITED
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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](https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-generic-medicines_en.pdf).