Overview
Mayzent is a medicine used to treat adults with an advanced form of multiple sclerosis (MS) known as secondary progressive MS.
It is used in patients with active disease, which means that patients still have relapses or signs of inflammation can be seen in scans.
Mayzent contains the active substance siponimod.
Mayzent can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the management of MS.
Mayzent is available as tablets and should be taken once a day. Treatment is started with a dose of 0.25 mg daily for two days. The dose is then progressively increased to reach the ‘maintenance’ dose on the sixth day. The maintenance dose is either 1 mg or 2 mg daily, depending on how quickly the patient’s body can process the medicine. This is determined by the use of a blood or saliva test to measure the activity of the patient’s liver enzyme CYP2C9.
For more information about using Mayzent, see the package leaflet or contact your doctor or pharmacist.
In MS, the immune system (the body’s defences) attacks and damages the protective sheath around the nerves in the brain and spinal cord.
The active substance in Mayzent, siponimod, blocks the action of some receptors (targets) on cells called sphingosine-1-phosphate receptors, which are involved in the movement of lymphocytes (immune cells) around the body. By attaching to these receptors, siponimod stops lymphocytes from travelling from the lymph nodes towards the brain and spinal cord, thus limiting the damage they cause in MS.
Mayzent was shown to be effective at delaying the progression of the disease in a 3-year main study involving 1,651 patients with secondary progressive MS, of whom 779 had active disease with a relapse within 2 years or other signs of inflammation in scans.
Disease progression was defined as worsening of the disease that is independent from a relapse and is maintained over at least 3 months, as assessed using a standard scale called EDSS. During the study, 25% of patients with active secondary progressive MS taking Mayzent had disease progression compared with 35% of patients taking placebo (a dummy treatment).
The most common side effects with Mayzent (which may affect more than 1 in 10 people) are headache and hypertension (high blood pressure).
Mayzent must not be used in patients who are hypersensitive (allergic) to siponimod, or to peanut, soya or any of the other ingredients of the medicine. The medicine must also not be used in patients who previously had certain severe infections (known as progressive multifocal leukoencephalopathy or cryptococcal meningitis). Mayzent must also not be used in patients with cancer and certain immune disorders due to its effect on the immune system. It must not be used in patients who have recently had a stroke and in patients with certain heart disorders (because of its effects on heart rate and blood pressure), severe liver disorders and in pregnant women and women who can become pregnant and are not using effective contraception.
Mayzent must also not be used in patients who have inherited a gene known as CYP2C9*3 from both parents, which makes them unable to process the medicine fast enough. For the full list of side effects and restrictions of Mayzent, see the package leaflet.
Mayzent was effective at delaying the progression of secondary progressive MS in patients with active disease; however, the beneficial effects of the medicine were not demonstrated in patients without an active disease. The European Medicines Agency therefore decided that Mayzent should only be used in patients whose disease is active with signs of inflammation.
The side effects with Mayzent are similar to those with another medicine (fingolimod) for MS working in a similar way and are considered acceptable.
The Agency therefore decided that Mayzent’s benefits are greater than its risks and it can be authorised for use in the EU.
The company that markets Mayzent will ensure that doctors expected to prescribe the medicine receive educational materials, including a checklist covering the necessary screening, pre-treatment and long-term monitoring of patients. The materials will include a guide for patients with key safety information about Mayzent, as well as a pregnancy reminder card for women who can become pregnant.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mayzent have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Mayzent are continuously monitored. Side effects reported with Mayzent are carefully evaluated and any necessary action taken to protect patients.
Mayzent received a marketing authorisation valid throughout the EU on 13 January 2020.
Mayzent : EPAR - Medicine overview
Reference Number: EMA/629863/2019
English (EN) (120.12 KB - PDF)
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български (BG) (143.5 KB - PDF)
First published: 23/01/2020
español (ES) (119.22 KB - PDF)
First published: 23/01/2020
čeština (CS) (140.57 KB - PDF)
First published: 23/01/2020
dansk (DA) (117.93 KB - PDF)
First published: 23/01/2020
Deutsch (DE) (121.97 KB - PDF)
First published: 23/01/2020
eesti keel (ET) (107.12 KB - PDF)
First published: 23/01/2020
ελληνικά (EL) (143.75 KB - PDF)
First published: 23/01/2020
français (FR) (120.39 KB - PDF)
First published: 23/01/2020
hrvatski (HR) (140.95 KB - PDF)
First published: 23/01/2020
italiano (IT) (117.88 KB - PDF)
First published: 23/01/2020
latviešu valoda (LV) (150.98 KB - PDF)
First published: 23/01/2020
lietuvių kalba (LT) (140.77 KB - PDF)
First published: 23/01/2020
magyar (HU) (140.16 KB - PDF)
First published: 23/01/2020
Malti (MT) (142.91 KB - PDF)
First published: 23/01/2020
Nederlands (NL) (117.98 KB - PDF)
First published: 23/01/2020
polski (PL) (142.74 KB - PDF)
First published: 23/01/2020
português (PT) (119.84 KB - PDF)
First published: 23/01/2020
română (RO) (139.64 KB - PDF)
First published: 23/01/2020
slovenčina (SK) (139.71 KB - PDF)
First published: 23/01/2020
slovenščina (SL) (138.77 KB - PDF)
First published: 23/01/2020
Suomi (FI) (116.37 KB - PDF)
First published: 23/01/2020
svenska (SV) (117.42 KB - PDF)
First published: 23/01/2020
Mayzent : EPAR - Risk-management-plan summary
English (EN) (142.15 KB - PDF)
First published: Last updated:
Product information
Mayzent : EPAR - Product information
English (EN) (694.51 KB - PDF)
First published: Last updated:
български (BG) (826.04 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
español (ES) (721.16 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
čeština (CS) (806.18 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
dansk (DA) (727.12 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
Deutsch (DE) (757.07 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
eesti keel (ET) (817.46 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
ελληνικά (EL) (856.92 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
français (FR) (840.62 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
hrvatski (HR) (804.78 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
íslenska (IS) (736.29 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
italiano (IT) (790.36 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
latviešu valoda (LV) (777.06 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
lietuvių kalba (LT) (798.4 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
magyar (HU) (828.31 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
Malti (MT) (855.01 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
Nederlands (NL) (781.71 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
norsk (NO) (705.7 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
polski (PL) (849.09 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
português (PT) (764.5 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
română (RO) (833.77 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
slovenčina (SK) (858.49 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
slovenščina (SL) (806.35 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
Suomi (FI) (704.77 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
svenska (SV) (687.28 KB - PDF)
First published: 23/01/2020Last updated: 14/05/2024
Latest procedure affecting product information: IA/0030
13/05/2024
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 authorisationholder responsible for batch release (annex IIA);
- conditions of themarketing authorisation(annex IIB);
- labelling(annex IIIA);
- package leaflet(annex IIIB).
Mayzent : EPAR - All authorised presentations
English (EN) (93.93 KB - PDF)
First published: Last updated:
български (BG) (103.15 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
español (ES) (94.21 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
čeština (CS) (97.96 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
dansk (DA) (94.61 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
Deutsch (DE) (95.72 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
eesti keel (ET) (94.28 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
ελληνικά (EL) (100.27 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
français (FR) (94.87 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
hrvatski (HR) (95.72 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
íslenska (IS) (96.09 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
italiano (IT) (94.15 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
latviešu valoda (LV) (98.58 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
lietuvių kalba (LT) (99.18 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
magyar (HU) (99.24 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
Malti (MT) (98.84 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
Nederlands (NL) (93.07 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
norsk (NO) (94.94 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
polski (PL) (98.96 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
português (PT) (94.92 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
română (RO) (96.75 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
slovenčina (SK) (98.97 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
slovenščina (SL) (92.97 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
Suomi (FI) (93.35 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
svenska (SV) (94.64 KB - PDF)
First published: 23/01/2020Last updated: 18/02/2022
Product details
- Name of medicine
Mayzent
- Active substance
Siponimod fumaric acid
- International non-proprietary name (INN) or common name
siponimod
- Therapeutic area (MeSH)
Multiple Sclerosis, Relapsing-Remitting
- Anatomical therapeutic chemical (ATC) code
L04
Pharmacotherapeutic group
Selective immunosuppressants
Therapeutic indication
Mayzent is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity.
Authorisation details
- EMA product number
EMEA/H/C/004712
Additional monitoring
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
- Marketing authorisation holder
Novartis Europharm Limited
Vista Building
Elm Park
Merrion Road
Dublin 4
D04 A9N6
Ireland- Opinion adopted
14/11/2019
- Marketing authorisation issued
13/01/2020
- Revision
13
Assessment history
Mayzent : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (141.28 KB - PDF)
First published: Last updated:
Mayzent-PSUSA-00010818-202303 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
Reference Number: EMA/484731/2023
English (EN) (149.91 KB - PDF)
First published:
Mayzent-PSUSA-00010818-202203 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
Reference Number: EMA/856981/2022
English (EN) (126.55 KB - PDF)
First published:
Mayzent-PSUSA-00010818-202109: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
Reference Number: EMA/260476/2022
English (EN) (145.93 KB - PDF)
First published:
Mayzent-H-C-4712-X-07 : EPAR - Assessment report - Variation
AdoptedReference Number: EMA/CHMP/11848/2022
English (EN) (544.79 KB - PDF)
First published:
Mayzent-PSUSA-00010818-202003: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
Reference Number: EMA/666450/2020
English (EN) (131.25 KB - PDF)
First published:
Mayzent : EPAR - Public assessment report
AdoptedReference Number: EMA/CHMP/652767/2019
English (EN) (3.3 MB - PDF)
First published:
CHMP summary of positive opinion for Mayzent
AdoptedReference Number: EMA/CHMP/596356/2019
English (EN) (67.99 KB - PDF)
First published:
News on Mayzent
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2019 (updated)
More information on Mayzent
- EMEA-000716-PIP01-09-M05 - paediatric investigation plan
Topics
Medicines
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