Fingolimod Mylan
fingolimod
Table of contents
Overview
Fingolimod Mylan is a medicine used to treat adults and children over 10 years of age with highly active relapsing-remitting multiple sclerosis (RRMS). ‘Relapsing-remitting’ means that the patient has flare-ups of symptoms (relapses) followed by periods with milder or no symptoms (remissions). Fingolimod Mylan is used when the disease remains active despite appropriate treatment with at least one other disease-modifying therapy, or is severe and getting worse rapidly.
Fingolimod Mylan contains the active substance fingolimod and is a ‘generic medicine’. This means that Fingolimod Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Gilenya.
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Fingolimod Mylan : EPAR - Medicine overview (PDF/143.67 KB)
First published: 31/08/2021
EMA/417663/2021 -
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Fingolimod Mylan : EPAR - Risk-management-plan summary (PDF/181.11 KB)
Adopted
First published: 31/08/2021
Last updated: 24/10/2022
Authorisation details
| Product details | |
|---|---|
| Name |
Fingolimod Mylan
|
| Agency product number |
EMEA/H/C/005661
|
| Active substance |
fingolimod hydrochloride
|
| International non-proprietary name (INN) or common name |
fingolimod
|
| Therapeutic area (MeSH) |
Multiple Sclerosis, Relapsing-Remitting
|
| Anatomical therapeutic chemical (ATC) code |
L04AA27
|
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. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Mylan Ireland Limited
|
| Revision |
4
|
| Date of issue of marketing authorisation valid throughout the European Union |
18/08/2021
|
| Contact address |
Unit 35/36 |
Product information
28/04/2023 Fingolimod Mylan - EMEA/H/C/005661 - IB/0007
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).
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
Immunosuppressants
Therapeutic indication
Indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:
Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1)
or
Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.