MedPath
EMA Approval

Fingolimod Accord

L04AA27

xl 04 aa 27

fingolimod

Multiple Sclerosis, Relapsing-Remitting

Basic Information

EMA regulatory identification and product classification information

EMA Identifiers

ATC CodeL04AA27
EMA European Classification

Overview Summary

Comprehensive product overview and regulatory summary

Fingolimod Accord 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 (RRMS). ‘Relapsing-remitting’ means that the patient has flare-ups of symptoms (relapses) followed by periods with milder or no symptoms (remissions). Fingolimod Accord 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 Accord is a ‘generic medicine’. This means that Fingolimod Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Gilenya.

Fingolimod Accord contains the active substance fingolimod.

Authorisations (1)

EMEA/H/C/005191

Accord Healthcare S.L.U.,Edificio Este Planta 6a,World Trade Center,Moll De Barcelona S/n,08039 Barcelona,SPAIN

Authorised

June 25, 2020

Active Substances (1)

fingolimod hydrochloride

Documents (11)

Fingolimod Accord : EPAR - Product Information

July 3, 2020

DRUG_PRODUCT_INFORMATION

Fingolimod Accord : EPAR - Procedural steps taken and scientific information after authorisation

July 31, 2024

CHANGES_SINCE_INITIAL_AUTHORISATION

Fingolimod Accord : EPAR - Public assessment report

July 3, 2020

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

CHMP summary of positive opinion for Fingolimod Accord

April 30, 2020

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Fingolimod Accord : EPAR - Public assessment report

July 3, 2020

CHANGES_SINCE_INITIAL_AUTHORISATION

CHMP summary of positive opinion for Fingolimod Accord

April 30, 2020

CHANGES_SINCE_INITIAL_AUTHORISATION

Fingolimod Accord : EPAR - Medicine overview

July 3, 2020

OVERVIEW_DOCUMENT

Fingolimod Accord : EPAR - Risk-management-plan summary

July 3, 2020

RISK_MANAGEMENT_PLAN_SUMMARY

Fingolimod Accord : EPAR - Procedural steps taken and scientific information after authorisation (archive)

August 31, 2021

CHANGES_SINCE_INITIAL_AUTHORISATION

Fingolimod Accord : EPAR - Procedural steps taken and scientific information after authorisation

August 31, 2021

CHANGES_SINCE_INITIAL_AUTHORISATION

Fingolimod Accord : EPAR - All Authorised presentations

July 3, 2020

AUTHORISED_PRESENTATIONS

Overview Q&A (7)

Question

How is Fingolimod Accord used?

Answer

Fingolimod Accord can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in multiple sclerosis. Fingolimod Accord is available as capsules (0.5 mg). The recommended dose for adults is one capsule taken once a day by mouth, the recommended dose for children depends on body weight.

Because Fingolimod Accord decreases the heart rate and can affect the heart’s electrical activity and rhythm, the patient’s blood pressure and heart activity are checked before starting treatment and during treatment, and also if Fingolimod Accord 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 Fingolimod Accord, see the package leaflet or contact your doctor or pharmacist.

Question

How does Fingolimod Accord work?

Answer

In multiple sclerosis, the immune system (the body’s defences) attacks and damages the protective insulation around the nerves and the nerves themselves in the brain and spinal cord.

The active substance in Fingolimod Accord, 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.

Question

What are the benefits and risks of Fingolimod Accord?

Answer

Because Fingolimod Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Question

Why is Fingolimod Accord authorised in the EU?

Answer

The European Medicines Agency concluded that, in accordance with EU requirements, Fingolimod Accord has been shown to have comparable quality and to be bioequivalent to Gilenya. Therefore, the Agency’s view was that, as for Gilenya, the benefits of Fingolimod Accord outweigh the identified risks and it can be authorised for use in the EU.

Question

What measures are being taken to ensure the safe and effective use of Fingolimod Accord?

Answer

The company that markets Fingolimod Accord must ensure that all doctors who prescribe the medicine receive an information pack containing important safety information, including a checklist of the risks with Fingolimod Accord 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 Fingolimod Accord. The pack will also include a reminder card for patients or their carers with key safety information about Fingolimod Accord, and a pregnancy-specific card to remind patients that Fingolimod Accord must not be used during pregnancy and in women who can become pregnant and are not using effective contraception.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fingolimod Accord have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Fingolimod Accord are continuously monitored. Side effects reported with Fingolimod Accord are carefully evaluated and any necessary action taken to protect patients.

Question

Other information about Fingolimod Accord

Answer

Fingolimod Accord received a marketing authorisation valid throughout the EU on 25 June 2020.

Question

How has Fingolimod Accord been studied?

Answer

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Gilenya, and do not need to be repeated for Fingolimod Accord.

As for every medicine, the company provided studies on the quality of Fingolimod Accord. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

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