Nordimet

methotrexate

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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 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.

For more information about treatment with Nordimet, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Nordimet : EPAR - Summary for the public BG = bălgarski 2016-09-29  
Nordimet : EPAR - Summary for the public ES = español 2016-09-29  
Nordimet : EPAR - Summary for the public CS = čeština 2016-09-29  
Nordimet : EPAR - Summary for the public DA = dansk 2016-09-29  
Nordimet : EPAR - Summary for the public DE = Deutsch 2016-09-29  
Nordimet : EPAR - Summary for the public ET = eesti keel 2016-09-29  
Nordimet : EPAR - Summary for the public EL = elliniká 2016-09-29  
Nordimet : EPAR - Summary for the public EN = English 2016-09-29  
Nordimet : EPAR - Summary for the public FR = français 2016-09-29  
Nordimet : EPAR - Summary for the public IT = italiano 2016-09-29  
Nordimet : EPAR - Summary for the public LV = latviešu valoda 2016-09-29  
Nordimet : EPAR - Summary for the public LT = lietuvių kalba 2016-09-29  
Nordimet : EPAR - Summary for the public HU = magyar 2016-09-29  
Nordimet : EPAR - Summary for the public MT = Malti 2016-09-29  
Nordimet : EPAR - Summary for the public NL = Nederlands 2016-09-29  
Nordimet : EPAR - Summary for the public PL = polski 2016-09-29  
Nordimet : EPAR - Summary for the public PT = português 2016-09-29  
Nordimet : EPAR - Summary for the public RO = română 2016-09-29  
Nordimet : EPAR - Summary for the public SK = slovenčina 2016-09-29  
Nordimet : EPAR - Summary for the public SL = slovenščina 2016-09-29  
Nordimet : EPAR - Summary for the public FI = suomi 2016-09-29  
Nordimet : EPAR - Summary for the public SV = svenska 2016-09-29  
Nordimet : EPAR - Summary for the public HR = Hrvatski 2016-09-29  

This EPAR was last updated on 15/06/2018 .

Authorisation details

Product details

Product details for Nordimet
NameNordimet
Agency product numberEMEA/H/C/003983
Active substance

methotrexate

International non-proprietary name (INN) or common name

methotrexate

Therapeutic area Arthritis, RheumatoidArthritis, PsoriaticPsoriasisArthritis, Juvenile Rheumatoid
Anatomical therapeutic chemical (ATC) code L04AX03

Publication details

Publication details for Nordimet
Marketing-authorisation holder

Nordic Group B.V.

Revision5
Date of issue of marketing authorisation valid throughout the European Union18/08/2016

Contact address:

Nordic Group B.V.
Siriusdreef 22 
NL-2132 WT Hoofddorp 
The Netherlands

Product information

Product information

16/05/2018  Nordimet -EMEA/H/C/003983 -PSUSA/00002014/201706

Name Language First published Last updated
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15
Nordimet : EPAR - Product Information HR = Hrvatski 2016-09-29 2018-06-15

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19
Nordimet : EPAR - All Authorised presentations HR = Hrvatski 2016-09-29 2017-10-19

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Nordimet is indicated for the treatment of:

  • active rheumatoid arthritis in adult patients,
  • polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate,
  • severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, psoralens and ultraviolet A (PUVA), and retinoids, and severe psoriatic arthritis in adult patients.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Nordimet : EPAR - Public assessment report HR = Hrvatski 2016-09-29  
CHMP summary of opinion for Nordimet HR = Hrvatski 2016-06-24  

Authorised

This medicine is approved for use in the European Union

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