Overview

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.

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.

Teriflunomide Mylan : EPAR - Medicine overview

български (BG) (156.97 KB - PDF)
español (ES) (135.51 KB - PDF)
čeština (CS) (154.63 KB - PDF)
dansk (DA) (134.69 KB - PDF)
Deutsch (DE) (138.65 KB - PDF)
eesti keel (ET) (122.9 KB - PDF)
ελληνικά (EL) (158.25 KB - PDF)
français (FR) (136.11 KB - PDF)
hrvatski (HR) (154.41 KB - PDF)
italiano (IT) (133.93 KB - PDF)
latviešu valoda (LV) (174.29 KB - PDF)
lietuvių kalba (LT) (155.9 KB - PDF)
magyar (HU) (155.97 KB - PDF)
Malti (MT) (159 KB - PDF)
Nederlands (NL) (136.21 KB - PDF)
polski (PL) (158 KB - PDF)
português (PT) (136.3 KB - PDF)
română (RO) (153.19 KB - PDF)
slovenčina (SK) (155.97 KB - PDF)
slovenščina (SL) (182.64 KB - PDF)
Suomi (FI) (132.94 KB - PDF)
svenska (SV) (133.63 KB - PDF)

Teriflunomide Mylan : EPAR - Risk management plan summary

Product information

Teriflunomide Mylan : EPAR - Product Information

български (BG) (588.76 KB - PDF)
español (ES) (481.93 KB - PDF)
čeština (CS) (544.76 KB - PDF)
dansk (DA) (493.46 KB - PDF)
Deutsch (DE) (604.57 KB - PDF)
eesti keel (ET) (465.65 KB - PDF)
ελληνικά (EL) (675.67 KB - PDF)
français (FR) (597.93 KB - PDF)
hrvatski (HR) (484.07 KB - PDF)
íslenska (IS) (491.77 KB - PDF)
italiano (IT) (531.18 KB - PDF)
latviešu valoda (LV) (593.92 KB - PDF)
lietuvių kalba (LT) (574.69 KB - PDF)
magyar (HU) (534.71 KB - PDF)
Malti (MT) (595.04 KB - PDF)
Nederlands (NL) (623.7 KB - PDF)
norsk (NO) (470.82 KB - PDF)
polski (PL) (623.08 KB - PDF)
português (PT) (644.14 KB - PDF)
română (RO) (730.6 KB - PDF)
slovenčina (SK) (567.53 KB - PDF)
slovenščina (SL) (477.12 KB - PDF)
Suomi (FI) (563.62 KB - PDF)
svenska (SV) (513.78 KB - PDF)

Latest procedure affecting product information: N/0001

10/01/2023

Globe icon

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).

Teriflunomide Mylan : EPAR - All Authorised Presentations

български (BG) (62.02 KB - PDF)
español (ES) (12.28 KB - PDF)
čeština (CS) (53.39 KB - PDF)
dansk (DA) (11.38 KB - PDF)
Deutsch (DE) (13.69 KB - PDF)
eesti keel (ET) (16.1 KB - PDF)
ελληνικά (EL) (55.67 KB - PDF)
français (FR) (12.25 KB - PDF)
hrvatski (HR) (51.06 KB - PDF)
íslenska (IS) (12.05 KB - PDF)
italiano (IT) (12.36 KB - PDF)
latviešu valoda (LV) (53.13 KB - PDF)
lietuvių kalba (LT) (52.09 KB - PDF)
magyar (HU) (53.58 KB - PDF)
Malti (MT) (52.2 KB - PDF)
Nederlands (NL) (12.19 KB - PDF)
norsk (NO) (12.09 KB - PDF)
polski (PL) (30.45 KB - PDF)
português (PT) (16.11 KB - PDF)
română (RO) (51.12 KB - PDF)
slovenčina (SK) (52.23 KB - PDF)
slovenščina (SL) (29.97 KB - PDF)
Suomi (FI) (11.51 KB - PDF)
svenska (SV) (11.18 KB - PDF)

Product details

Name of medicine
Teriflunomide Mylan
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

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).

 

Authorisation details

EMA product number
EMEA/H/C/005962

Generic

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.

Marketing authorisation holder
Mylan Pharmaceuticals Limited

Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Opinion adopted
15/09/2022
Marketing authorisation issued
09/11/2022
Revision
1

Assessment history

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

Teriflunomide Mylan : EPAR - Public Assessment Report

CHMP summary of positive opinion for Teriflunomide Mylan

This page was last updated on

How useful do you find this page?