<p>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. </p><p>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.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>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:</p> <p>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)</p> <p>or</p> <p>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.</p> </div>
Therapeutic Area (MeSH)
ATC Code
L04AE01
ATC Item
N/A
Pharmacotherapeutic Group
Immunosuppressants
Active Substance (Summary)
N/AINN / Common Names
EMA Name
Fingolimod Mylan
Medicine Name
Fingolimod Mylan
Aliases
N/ANo risk management plan link.
