Gilenya
What Gilenya is used for
Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients 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.
Approved use, as published by the European Medicines Agency.
Key facts
- Brand
- Gilenya
- Active substance
- fingolimod
- Disease area
- Multiple Sclerosis
- Medicine group
- Immunosuppressants
- ATC code
- L04AE01
- Marketing authorisation holder
- Novartis Europharm Limited
- Authorised in the EU since
- 2011
Official information
In India
- Fingolimod hydrochloride: 2 brands in India
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Gilenya used for?
Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients 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 br…
What is the active substance in Gilenya?
Gilenya contains fingolimod.
Who makes Gilenya?
The EU marketing authorisation holder is Novartis Europharm Limited.
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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