Human medicines European public assessment report (EPAR): Gilenya, fingolimod, Date of authorisation: 17/03/2011, Revision: 42, Status: Authorised

Overview

Gilenya is a type of medicine known as a 'disease-modifying therapy' that is used to treat adults and children over 10 years of age with highly active relapsing-remitting multiple sclerosis (MS), a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells. 'Relapsing-remitting' means that the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions). Gilenya 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. Gilenya contains the active substance fingolimod. Expand section Collapse section How is Gilenya used? Gilenya can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in multiple sclerosis. Gilenya is available as capsules (0.25 mg and 0.5 mg). The recommended dose for adults is one 0.5 mg capsule taken once a day by mouth, the recommended dose for children depends on body weight. Because Gilenya decreases the heart rate and can affect the heart's electrical activity and rhythm, the patient's blood pressure and heart activity is checked before starting treatment and during treatment, and also if Gilenya treatment is restarted after an interruption. Details on the recommendations for monitoring patients are found in the summary of product characteristics. For more information about using Gilenya, see the package leaflet or contact your doctor or pharmacist. How does Gilenya work? In multiple sclerosis, the immune system (the body's defences) incorrectly attacks the protective sheath around the nerves in the brain and spinal cord. The active substance in Gilenya, fingolimod, prevents T cells (a type of white blood cell involved in the immune system) travelling from the lymph nodes towards the brain and spinal cord, thus limiting the damage they cause in multiple sclerosis. It does this by blocking the action of a receptor (target) on the T cells called the sphingosine-1- phosphate receptor, which is involved in controlling the movement of these cells in the body. What benefits of Gilenya have been shown in studies? Three main studies in adults and one main study in children have found that Gilenya was more effective than placebo (a dummy treatment) or interferon beta-1a (another medicine for treating multiple sclerosis) in patients with relapsing-remitting multiple sclerosis. The main measure of effectiveness in all the studies was based on the number of relapses the patients experienced each year. In two studies involving a total of 2,355 patients, Gilenya was compared with placebo over two years. Patients treated with Gilenya had around half the number of relapses compared with patients given placebo. In a third study involving 1,292 patients, Gilenya was compared with interferon beta-1a over one year. Patients receiving Gilenya had around half the number of relapses compared with patients given interferon beta-1a. In a study involving 215 children, Gilenya was compared with interferon beta-1a for up to 2 years. Of patients given Gilenya, 14% (15 out of 107) experienced relapses compared with 54% (58 out of 107) of patients given interferon beta-1a. What are the risks associated with Gilenya? The most common side effects with Gilenya (seen in more than 1 patient in 10) are flu, sinusitis (inflammation of the sinuses), headache, cough, diarrhoea, back pain and raised liver enzyme levels (a sign of liver problems). The most serious side effects are infections, macular oedema (swelling in the central part of the retina at the back of the eye) and atrioventricular block (a type of heart rhythm disorder) at the start of treatment. For the full list of side effects of Gilenya, see the package leaflet. Gilenya must not be used in patients at risk of infections due to a weakened immune system, patients with a severe infection or a long-term active infection such as hepatitis, and patients with cancer or severe liver problems. Gilenya must also not be used in patients with certain diseases affecting the heart and blood vessels or in those who have had such diseases or problems with the blood supply to the brain. Women should not become pregnant while taking Gilenya and for two months after treatment has stopped. For the full list of restrictions, see the package leaflet. Why is Gilenya authorised in the EU? The European Medicines Agency concluded that there is clear evidence of the benefit of Gilenya in relapsing-remitting multiple sclerosis in both adults and children and noted that it had the benefit of being taken by mouth while most other medicines for this disease are given by injection. However, because of possible side effects, the Agency concluded that Gilenya should only be used in patients who have a real need for the medicine either because their disease has not improved with at least one other disease-modifying therapy or because it is severe and getting worse rapidly. In addition, the Agency concluded that all patients should have their heart activity closely monitored after the first dose. The Agency decided that Gilenya's benefits are greater than its risks and recommended that it be given marketing authorisation. What measures are being taken to ensure the safe and effective use of Gilenya? The company that markets Gilenya will provide results from a study to assess the risk of side effects on the heart and circulation. It must also ensure that all doctors who prescribe Gilenya receive an information pack containing important safety information, including a checklist of the risks with Gilenya and the situations where its use is not recommended. The checklist includes information on the tests and monitoring in patients before and during treatment with Gilenya. The pack will also include information on a registry to collect data on babies born to women treated with Gilenya, as well as a patient reminder card for patients or their carers with key safety information. Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Gilenya have also been included in the summary of product characteristics and the package leaflet. As for all medicines, data on the use of Gilenya are continuously monitored. Side effects reported with Gilenya are carefully evaluated and any necessary action taken to protect patients. Other information about Gilenya Gilenya received a marketing authorisation valid throughout the EU on 17 March 2011. Gilenya : EPAR - Medicine overview Reference Number: EMA/685570/2018 English (EN) (81.82 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View Other languages (22) български (BG) (116.55 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View español (ES) (79.34 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View čeština (CS) (105.23 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View dansk (DA) (77.95 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View Deutsch (DE) (80.18 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View eesti (ET) (78.17 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View ελληνικά (EL) (114.83 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View français (FR) (80.17 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View hrvatski (HR) (100.97 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View italiano (IT) (78.42 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View latviešu (LV) (103.74 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View lietuvių (LT) (110.87 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View magyar (HU) (100.69 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View Malti (MT) (106.18 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View Nederlands (NL) (78.58 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View polski (PL) (104.43 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View português (PT) (79.44 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View română (RO) (102.78 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View slovenčina (SK) (104.51 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View slovenščina (SL) (97.57 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View suomi (FI) (77.97 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View svenska (SV) (78.64 KB - PDF) First published: 30/03/2011 Last updated: 18/12/2018 View Gilenya : EPAR - Risk Management Plan English (EN) (1.4 MB - PDF) First published: 01/06/2023 Last updated: 23/09/2025 View

Product information

Gilenya : EPAR - Product Information English (EN) (473.53 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View Other languages (24) български (BG) (625.72 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View español (ES) (535.67 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View čeština (CS) (578.06 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View dansk (DA) (535.54 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View Deutsch (DE) (553.48 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View eesti (ET) (527.95 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View ελληνικά (EL) (636.52 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View français (FR) (627.7 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View hrvatski (HR) (566.08 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View italiano (IT) (543.07 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View latviešu (LV) (556.11 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View lietuvių (LT) (601.48 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View magyar (HU) (571.53 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View Malti (MT) (644.75 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View Nederlands (NL) (572.34 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View polski (PL) (652.25 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View português (PT) (527.65 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View română (RO) (595.67 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View slovenčina (SK) (583.4 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View slovenščina (SL) (568.71 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View suomi (FI) (577.7 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View svenska (SV) (514.26 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View Íslenska (IS) (522.35 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View norsk (NO) (510.02 KB - PDF) First published: 30/03/2011 Last updated: 30/07/2026 View Latest procedure affecting product information: VR/0000339039 11/06/2026 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). Gilenya : EPAR - All Authorised presentations English (EN) (47.06 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View Other languages (24) български (BG) (59.1 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View español (ES) (47.41 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View čeština (CS) (52.33 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View dansk (DA) (48.37 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View Deutsch (DE) (50.17 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View eesti (ET) (46.46 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View ελληνικά (EL) (56.36 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View français (FR) (49.93 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View hrvatski (HR) (49.73 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View italiano (IT) (48.09 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View latviešu (LV) (52.38 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View lietuvių (LT) (52.32 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View magyar (HU) (53.24 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View Malti (MT) (53.02 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View Nederlands (NL) (46.77 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View polski (PL) (52.39 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View português (PT) (47.09 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View română (RO) (51.34 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View slovenčina (SK) (53.14 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View slovenščina (SL) (49.45 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View suomi (FI) (45.82 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View svenska (SV) (47.43 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View Íslenska (IS) (49.48 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View norsk (NO) (47.45 KB - PDF) First published: 30/03/2011 Last updated: 10/05/2023 View Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV English (EN) (211.72 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View Other languages (23) български (BG) (231.47 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View español (ES) (207.42 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View čeština (CS) (221.57 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View dansk (DA) (210.48 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View Deutsch (DE) (216.69 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View eesti (ET) (206.11 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View ελληνικά (EL) (219.99 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View français (FR) (217.73 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View italiano (IT) (213.29 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View latviešu (LV) (218.73 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View lietuvių (LT) (237.34 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View magyar (HU) (216.8 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View Malti (MT) (243.71 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View Nederlands (NL) (211.51 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View polski (PL) (223.06 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View português (PT) (210.78 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View română (RO) (216.96 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View slovenčina (SK) (222 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View slovenščina (SL) (216.65 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View suomi (FI) (208.83 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View svenska (SV) (206.06 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View Íslenska (IS) (213.53 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View norsk (NO) (207.94 KB - PDF) First published: 30/03/2011 Last updated: 06/07/2012 View

Product details

Name of medicine Gilenya Active substance fingolimod hydrochloride International non-proprietary name (INN) or common name fingolimod Therapeutic area (MeSH) Multiple Sclerosis Anatomical therapeutic chemical (ATC) code L04AE01 Pharmacotherapeutic group Immunosuppressants Therapeutic indication 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.

Authorisation details

EMA product number EMEA/H/C/002202 Marketing authorisation holder Novartis Europharm Limited Vista Building Elm Park Merrion Road Dublin 4 Ireland Opinion adopted 20/01/2011 Marketing authorisation issued 17/03/2011 Revision 42

Assessment history

Expand section Collapse section Changes since initial authorisation of medicine Gilenya : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (144.58 KB - PDF) First published: 23/09/2025 Last updated: 30/07/2026 View Gilenya : EPAR - Procedural steps taken and scientific information after authorisation (archive) English (EN) (350.65 KB - PDF) First published: 02/09/2011 Last updated: 23/09/2025 View Gilenya-PAM-0000295236 : EPAR - Assessment report Reference Number: EMADOC-1700519818-2443340 English (EN) (2.06 MB - PDF) First published: 02/12/2025 View Gilenya-H-C-2202-P46-039 : EPAR - Assessment Report Adopted Reference Number: EMA/CHMP/716292/2021 English (EN) (424.66 KB - PDF) First published: 06/12/2021 View Gilenya-H-C-PSUSA-00001393-202002: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Reference Number: EMA/601114/2020 English (EN) (161.24 KB - PDF) First published: 18/12/2020 View Gilenya-H-C-PSUSA-00001393-201902 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Reference Number: EMA/601061/2019 English (EN) (69.89 KB - PDF) First published: 20/12/2019 View Gilenya-H-C-2202-X-0044-G : EPAR - Assessment Report - Variation Adopted Reference Number: EMA/779102/2018 English (EN) (775.18 KB - PDF) First published: 19/02/2019 View Gilenya-H-C-PSUSA-00001393-201802 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation English (EN) (67.4 KB - PDF) First published: 18/12/2018 View CHMP post-authorisation summary of positive opinion for Gilenya (X/44/G) Adopted Reference Number: EMA/CHMP/612718/2018 English (EN) (72.63 KB - PDF) First published: 21/09/2018 Last updated: 21/09/2018 View Gilenya-H-C-PSUSA-00001393-201702 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s) English (EN) (66.83 KB - PDF) First published: 12/02/2018 Last updated: 12/02/2018 View Gilenya-H-C-PSUSA-00001393-201602 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Reference Number: EMA/879483/2016 English (EN) (49.47 KB - PDF) First published: 21/12/2016 Last updated: 21/12/2016 View Gilenya-H-C-PSUSA-00001393-201502 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation Reference Number: EMA/699354/2015 English (EN) (68.08 KB - PDF) First published: 07/03/2016 Last updated: 07/03/2016 View Gilenya-H-C-2202-II-0034 : EPAR - Assessment Report - Variation Adopted Reference Number: EMA/CHMP/549382/2015 English (EN) (4.39 MB - PDF) First published: 17/12/2015 Last updated: 17/12/2015 View CHMP post-authorisation summary of positive opinion for Gilenya Adopted Reference Number: EMA/CHMP/627232/2015 English (EN) (71.32 KB - PDF) First published: 25/09/2015 Last updated: 25/09/2015 View Gilenya-H-C-PSUV-0027 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation Reference Number: EMA/405985/2014 English (EN) (74.38 KB - PDF) First published: 11/07/2014 Last updated: 11/07/2014 View Gilenya-H-C-2202-II-0021 : EPAR - Assessment Report - Variation Adopted Reference Number: EMA/195551/2014 English (EN) (1.52 MB - PDF) First published: 27/06/2014 Last updated: 27/06/2014 View CHMP post-authorisation summary of positive opinion for Gilenya Adopted Reference Number: EMA/243755/2014 English (EN) (69.91 KB - PDF) First published: 25/04/2014 Last updated: 25/04/2014 View Gilenya-H-C-2202-PSUV-0023 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation Reference Number: EMA/177651/2014 English (EN) (71.94 KB - PDF) First published: 01/04/2014 Last updated: 01/04/2014 View Gilenya-H-C-2202-A20-0008 : EPAR - Assessment Report - Article 20 Adopted Reference Number: EMA/357270/2012 English (EN) (423.12 KB - PDF) First published: 06/07/2012 Last updated: 06/07/2012 View Initial marketing authorisation documents Gilenya : EPAR - Public assessment report Adopted Reference Number: EMA/108602/2011 English (EN) (1.68 MB - PDF) First published: 30/03/2011 Last updated: 30/03/2011 View CHMP summary of positive opinion for Gilenya Adopted Reference Number: EMA/26661/2011 English (EN) (120.1 KB - PDF) First published: 21/01/2011 Last updated: 21/01/2011 View

More information on Gilenya

EMEA-000087-PIP01-07-M05 - paediatric investigation plan Gilenya - direct healthcare professional communication (DHPC)