Nordimet

methotrexate

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

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 with psoriasis.

Nordimet contains the active substance methotrexate.

Nordimet is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicines’ containing the same active substance, but Nordimet is available in more strengths. The reference medicine for Nordimet is Lantarel FS.

: Nordimet is available as various strengths of injection and it can only be obtained with a prescription. It should be prescribed only by doctors with expertise in the use of methotrexate and a full understanding of the risks of methotrexate treatment.
Nordimet should be injected under the skin once a week on the same day each week. The dose injected each week depends on which condition it is being used for and how well the treatment is working and, for children, on the child’s height and weight. In most cases, methotrexate medicines are used for long-term treatment.
For more information about using Nordimet, see the package leaflet or contact your doctor or pharmacist.

: The way methotrexate, the active substance in Nordimet, works in 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.

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

: The most common side effects with Nordimet (which may affect more than 1 in 10 people) are effects in the digestive system (such as inflammation of the lining of the mouth, indigestion, belly pain, feeling sick and loss of appetite) and blood tests showing changes in the liver. The most serious side effects include reduced production of blood cells, damage to the lung, liver, kidneys and nerves, thromboembolism (problems caused by clots in blood vessels), and severe allergic and skin reactions.
Nordimet must not be used in patients who abuse alcohol or those with liver or severe kidney problems, blood disorders, weakened immune system (body defences), severe or long-term infections such as tuberculosis and HIV infection, mouth ulcers, inflammation in the mouth, and ulcers in the digestive system. It must not be used if the patient is pregnant, breastfeeding or is receiving live vaccines.
For the full list of side effects and restrictions of Nordimet, see the package leaflet.

: The European Medicines Agency concluded that Nordimet was comparable to its reference medicine. The Agency therefore decided that Nordimet’s benefits are greater than its risks and it can be authorised for use in the EU.

: The company that markets Nordimet will send out follow-up questionnaires for dosing errors that result in overdose.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nordimet have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Nordimet are continuously monitored. Side effects reported with Nordimet are carefully evaluated and any necessary action taken to protect patients.

: Nordimet received a marketing authorisation valid throughout the EU on 18 August 2016.

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Nordimet : EPAR - Medicine overview (PDF/80.88 KB)

First published: 29/09/2016
Last updated: 31/10/2019
- Bulgarian
  (PDF/101.35 KB)
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  (PDF/91.88 KB)
- Czech
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- Danish
  (PDF/73.2 KB)
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- Estonian
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- Finnish
  (PDF/73.05 KB)
- French
  (PDF/74.58 KB)
- German
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- Greek
  (PDF/107.45 KB)
- Hungarian
  (PDF/92.27 KB)
- Italian
  (PDF/73.53 KB)
- Latvian
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- Lithuanian
  (PDF/95.79 KB)
- Maltese
  (PDF/97.89 KB)
- Polish
  (PDF/97.03 KB)
- Portuguese
  (PDF/74.18 KB)
- Romanian
  (PDF/106.56 KB)
- Slovak
  (PDF/96.86 KB)
- Slovenian
  (PDF/90.34 KB)
- Spanish
  (PDF/74.23 KB)
- Swedish
  (PDF/73.67 KB)
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Nordimet : EPAR - Risk-management-plan summary (PDF/171.42 KB)

First published: 02/02/2021

This EPAR was last updated on 08/05/2023

Authorisation details

Product details
Name	Nordimet
Agency product number	EMEA/H/C/003983
Active substance	Methotrexate
International non-proprietary name (INN) or common name	methotrexate
Therapeutic area (MeSH)	Arthritis, Psoriatic Psoriasis Arthritis, Juvenile Rheumatoid Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code	L04AX03

Publication details
Marketing-authorisation holder	Nordic Group B.V.
Revision	19
Date of issue of marketing authorisation valid throughout the European Union	18/08/2016
Contact address	Siriusdreef 41 NL-2132 WT Hoofddorp The Netherlands

Product information

30/03/2023 Nordimet - EMEA/H/C/003983 - IB/0030

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Nordimet : EPAR - Product Information (PDF/1.12 MB)

First published: 29/09/2016
Last updated: 08/05/2023
- Bulgarian
  (PDF/1.42 MB)
- Croatian
  (PDF/1.4 MB)
- Czech
  (PDF/1.34 MB)
- Danish
  (PDF/1.29 MB)
- Dutch
  (PDF/1.26 MB)
- Estonian
  (PDF/1.27 MB)
- Finnish
  (PDF/1.07 MB)
- French
  (PDF/1.39 MB)
- German
  (PDF/1.34 MB)
- Greek
  (PDF/1.42 MB)
- Hungarian
  (PDF/1.33 MB)
- Icelandic
  (PDF/1.24 MB)
- Italian
  (PDF/1.26 MB)
- Latvian
  (PDF/1.38 MB)
- Lithuanian
  (PDF/1.39 MB)
- Maltese
  (PDF/1.42 MB)
- Norwegian
  (PDF/1.26 MB)
- Polish
  (PDF/1.48 MB)
- Portuguese
  (PDF/1.28 MB)
- Romanian
  (PDF/1.49 MB)
- Slovak
  (PDF/1.48 MB)
- Slovenian
  (PDF/1.36 MB)
- Spanish
  (PDF/1.11 MB)
- Swedish
  (PDF/1.29 MB)

Other EU languages available icon 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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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Nordimet : EPAR - All Authorised presentations (PDF/134.92 KB)

First published: 29/09/2016
Last updated: 23/08/2022
- Bulgarian
  (PDF/205.71 KB)
- Croatian
  (PDF/156.21 KB)
- Czech
  (PDF/170.31 KB)
- Danish
  (PDF/167.82 KB)
- Dutch
  (PDF/155.55 KB)
- Estonian
  (PDF/154.6 KB)
- Finnish
  (PDF/192.95 KB)
- French
  (PDF/165.69 KB)
- German
  (PDF/162.07 KB)
- Greek
  (PDF/164.82 KB)
- Hungarian
  (PDF/156.83 KB)
- Icelandic
  (PDF/181.15 KB)
- Italian
  (PDF/155.93 KB)
- Latvian
  (PDF/162.27 KB)
- Lithuanian
  (PDF/171.04 KB)
- Maltese
  (PDF/177.45 KB)
- Norwegian
  (PDF/161.19 KB)
- Polish
  (PDF/195.43 KB)
- Portuguese
  (PDF/160.08 KB)
- Romanian
  (PDF/164.38 KB)
- Slovak
  (PDF/181.08 KB)
- Slovenian
  (PDF/163.85 KB)
- Spanish
  (PDF/178.18 KB)
- Swedish
  (PDF/188.09 KB)

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,
induction of remission in moderate steroid-dependent Crohn's disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate.

Assessment history

Changes since initial authorisation of medicine

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Nordimet : EPAR - Procedural steps taken and scientific information after authorisation (PDF/160.37 KB)

First published: 21/10/2016
Last updated: 08/05/2023
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Nordimet-H-C-3983-II-0016 : EPAR - Assessment report - Variation (PDF/1.2 MB)

Adopted

First published: 02/02/2021
EMA/56247/2021
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CHMP post-authorisation summary of positive opinion for Nordimet (II-16) (PDF/122.12 KB)

Adopted

First published: 11/12/2020
EMA/CHMP/658053/2020
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Nordimet-H-C-PSUSA-00002014-201910 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/134.66 KB)

First published: 30/07/2020
EMA/405544/2020
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Methotrexate Article-31 referral - Annex II (PDF/48.08 KB)

First published: 31/10/2019
- Bulgarian
  (PDF/70.65 KB)
- Croatian
  (PDF/88.18 KB)
- Czech
  (PDF/96.45 KB)
- Danish
  (PDF/48.48 KB)
- Dutch
  (PDF/50.84 KB)
- Estonian
  (PDF/48.23 KB)
- Finnish
  (PDF/49.34 KB)
- French
  (PDF/52.78 KB)
- German
  (PDF/110.91 KB)
- Greek
  (PDF/101.99 KB)
- Hungarian
  (PDF/81.89 KB)
- Italian
  (PDF/49.13 KB)
- Latvian
  (PDF/91.68 KB)
- Lithuanian
  (PDF/98.34 KB)
- Maltese
  (PDF/105.98 KB)
- Polish
  (PDF/95.12 KB)
- Portuguese
  (PDF/51.81 KB)
- Romanian
  (PDF/92.88 KB)
- Slovak
  (PDF/91.73 KB)
- Slovenian
  (PDF/87.25 KB)
- Spanish
  (PDF/52.71 KB)
- Swedish
  (PDF/50.58 KB)
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Methotrexate Article-31 referral - Public assessment report - EMEA/H/A-31/1463 (PDF/323.24 KB)

First published: 31/10/2019
EMA/521627/2019
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Nordimet-H-C-PSUSA-00002014-201810 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/69.8 KB)

First published: 06/09/2019
EMA/492014/2019
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Nordimet-H-C-PSUSA-00002014-201706 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/67.78 KB)

First published: 15/06/2018
Last updated: 15/06/2018
EMA/357560/2018

Nordimet

Table of contents

Overview

Nordimet : EPAR - Medicine overview (PDF/80.88 KB)

Nordimet : EPAR - Risk-management-plan summary (PDF/171.42 KB)

Authorisation details

Product information

Nordimet : EPAR - Product Information (PDF/1.12 MB)

Nordimet : EPAR - All Authorised presentations (PDF/134.92 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Nordimet : EPAR - Procedural steps taken and scientific information after authorisation (PDF/160.37 KB)

Nordimet-H-C-3983-II-0016 : EPAR - Assessment report - Variation (PDF/1.2 MB)

CHMP post-authorisation summary of positive opinion for Nordimet (II-16) (PDF/122.12 KB)

Nordimet-H-C-PSUSA-00002014-201910 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/134.66 KB)

Methotrexate Article-31 referral - Annex II (PDF/48.08 KB)

Methotrexate Article-31 referral - Public assessment report - EMEA/H/A-31/1463 (PDF/323.24 KB)

Nordimet-H-C-PSUSA-00002014-201810 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/69.8 KB)

Nordimet-H-C-PSUSA-00002014-201706 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/67.78 KB)

Initial marketing-authorisation documents

Nordimet : EPAR - Public assessment report (PDF/217.86 KB)

CHMP summary of opinion for Nordimet (PDF/75.13 KB)

News

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