Nordimet

Summary

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/458697/2016

EMEA/H/C/003983

EPAR summary for the public

Nordimet

methotrexate

This is a summary of the European public assessment report (EPAR) for Nordimet. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Nordimet.

For practical information about using Nordimet, patients should read the package leaflet or contact their doctor or pharmacist.

What is Nordimet and what is it used for?

Nordimet is a medicine used to treat the following inflammatory conditions:

• active rheumatoid arthritis, a disease causing inflammation in joints;

• severe juvenile idiopathic arthritis (JIA), a joint disease in children, when medicines known as NSAIDs (non-steroidal anti-inflammatory drugs) have not worked well enough;

• severe disabling psoriasis, a disease causing red, scaly patches on the skin, when other treatments have not worked well enough;

• severe psoriatic arthritis, inflammation of the joints that occurs in patients with psoriasis.

Nordimet is a 'hybrid medicine'. This means that it is similar to a 'reference medicine' (in this case Lantarel FS) containing the same active substance (methotrexate). The difference between Nordimet and Lantarel FS is that Nordimet is available in more strengths.

How is Nordimet used?

Nordimet is available as a solution of various strengths and should be injected under the skin once a week on the same day each week. The dose depends on the condition it is being used to treat and how

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the patient responds to treatment and, in the case of children, on the body surface area. In most cases, Nordimet is used for long-term treatment.

Getting the dose or timing of injections wrong can lead to serious side effects. Doctors prescribing this medicine must have experience with methotrexate and understand how it works. The medicine can only be obtained with a prescription.

For more information on how to use Nordimet, see the package leaflet.

How does Nordimet work?

The active substance in Nordimet, methotrexate, stops cells from growing too fast by interfering with the production of DNA. The reason that this action helps patients with arthritis and psoriasis is not completely understood, but the benefits of methotrexate are thought to be due to its ability to reduce inflammation and suppress an overactive immune system.

How has Nordimet been studied?

The company provided data from the published literature on methotrexate. No additional studies were needed as Nordimet is a hybrid medicine that is given by injection and contains the same active substance as the reference medicine, Lantarel FS.

What benefits of Nordimet have been shown in studies?

Because Nordimet has the same composition as the reference medicine, Lantarel FS, its benefits and risks are taken as being the same as those of Lantarel FS.

Why is Nordimet approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Nordimet has been shown to be comparable to reference medicine. Therefore, the CHMP's view was that, as for reference medicine, the benefits of Nordimet outweighs it risks. The Committee recommended that Nordimet be approved for use in the EU.

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

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

Other information about Nordimet

The European Commission granted a marketing authorisation valid throughout the European Union for Nordimet on 18 August 2016.

The full EPAR for Nordimet can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Nordimet, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 08-2016.

Nordimet

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