Teriflunomide Mylan



This medicine is authorised for use in the European Union.


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

This EPAR was last updated on 16/01/2023

Authorisation details

Product details
Teriflunomide Mylan
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Multiple Sclerosis, Relapsing-Remitting
Anatomical therapeutic chemical (ATC) code

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Mylan Pharmaceuticals Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,

Product information

10/01/2023 Teriflunomide Mylan - EMEA/H/C/005962 - N/0001

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


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).


Assessment history

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