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;
plaque psoriasis (a disease causing red, scaly patches on the skin) in adults with moderate to severe disease who can be treated with a medicine given by mouth or injection;
severe psoriatic arthritis, inflammation of the joints that occurs in patients with psoriasis;
Crohn's disease (a disease causing inflammation of the gut) in adults. It can be used in combination with corticosteroids or on its own to induce or maintain remission (a period without disease symptoms after treatment).

Nordimet contains the active substance methotrexate.

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

: Nordimet is available in pre-filled injection pens or syringes 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.
A doctor may decide that patients can inject Nordimet themselves after receiving adequate training, but the first self-injection should be supervised by a doctor or a nurse.
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, psoriasis and Crohn’s disease 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.

: For the full list of side effects and restrictions of Nordimet, see the package leaflet.
The most common side effects with Nordimet (which may affect more than 1 in 10 people) include effects on 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 how well the liver works. The most serious side effects include reduced production of blood cells, damage to the lungs, liver, kidneys and nerves, thromboembolism (problems caused by clots in blood vessels), severe allergic reactions and Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals).
Nordimet must not be used in patients who abuse alcohol or those with severe liver or kidney problems, blood disorders, weakened immune system (the body’s natural defences), severe or long-term infections such as tuberculosis and HIV infection, mouth ulcers, inflammation of the lining of the mouth, and ulcers in the digestive system. It must not be used if the patient is pregnant, breastfeeding or is receiving live vaccines.

: 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.

List item

Nordimet : EPAR - Medicine overview (PDF/146.5 KB) (updated)

First published: 29/09/2016
Last updated: 20/11/2023
EMA/480738/2023
- Bulgarian
  (PDF/131.51 KB)
- Croatian
  (PDF/121.39 KB)
- Czech
  (PDF/127.33 KB)
- Danish
  (PDF/106.88 KB)
- Dutch
  (PDF/107.54 KB)
- Estonian
  (PDF/106.36 KB)
- Finnish
  (PDF/106.91 KB)
- French
  (PDF/108.07 KB)
- German
  (PDF/107.96 KB)
- Greek
  (PDF/139.4 KB)
- Hungarian
  (PDF/122.23 KB)
- Italian
  (PDF/107.27 KB)
- Latvian
  (PDF/135.05 KB)
- Lithuanian
  (PDF/125.82 KB)
- Maltese
  (PDF/127.16 KB)
- Polish
  (PDF/126.73 KB)
- Portuguese
  (PDF/107.44 KB)
- Romanian
  (PDF/123.86 KB)
- Slovak
  (PDF/125.68 KB)
- Slovenian
  (PDF/120.89 KB)
- Spanish
  (PDF/107.61 KB)
- Swedish
  (PDF/106.7 KB)
List item

Nordimet : EPAR - Risk-management-plan summary (PDF/118.54 KB)

First published: 02/02/2021
Last updated: 27/10/2023

This EPAR was last updated on 20/11/2023

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	22
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

18/10/2023 Nordimet - EMEA/H/C/003983 - II/0027

List item

Nordimet : EPAR - Product Information (PDF/1.05 MB)

First published: 29/09/2016
Last updated: 27/10/2023
- Bulgarian
  (PDF/1.43 MB)
- Croatian
  (PDF/1.39 MB)
- Czech
  (PDF/1.35 MB)
- Danish
  (PDF/1.3 MB)
- Dutch
  (PDF/1.27 MB)
- Estonian
  (PDF/1.31 MB)
- Finnish
  (PDF/1.25 MB)
- French
  (PDF/1.4 MB)
- German
  (PDF/1.36 MB)
- Greek
  (PDF/1.43 MB)
- Hungarian
  (PDF/1.34 MB)
- Icelandic
  (PDF/1.25 MB)
- Italian
  (PDF/1.27 MB)
- Latvian
  (PDF/1.39 MB)
- Lithuanian
  (PDF/1.46 MB)
- Maltese
  (PDF/1.43 MB)
- Norwegian
  (PDF/1.27 MB)
- Polish
  (PDF/1.59 MB)
- Portuguese
  (PDF/1.28 MB)
- Romanian
  (PDF/1.7 MB)
- Slovak
  (PDF/1.17 MB)
- Slovenian
  (PDF/1.37 MB)
- Spanish
  (PDF/1.3 MB)
- Swedish
  (PDF/1.3 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.

List item

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,
moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, 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

List item

Nordimet : EPAR - Procedural steps taken and scientific information after authorisation (PDF/188.27 KB)

First published: 21/10/2016
Last updated: 27/10/2023
List item

Nordimet-H-C-3983-II-0027 : EPAR - Assessment report - Variation (PDF/1.82 MB)

Adopted

First published: 27/10/2023
EMA/439575/2023
List item

CHMP post-authorisation summary of positive opinion for Nordimet (II-27) (PDF/125.51 KB)

Adopted

First published: 15/09/2023
EMA/CHMP/354618/2023
List item

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

Adopted

First published: 02/02/2021
EMA/56247/2021
List item

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
List item

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
List item

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)
List item

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

First published: 31/10/2019
EMA/521627/2019
List item

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
List item

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/146.5 KB) (updated)

Nordimet : EPAR - Risk-management-plan summary (PDF/118.54 KB)

Authorisation details

Product information

Nordimet : EPAR - Product Information (PDF/1.05 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/188.27 KB)

Nordimet-H-C-3983-II-0027 : EPAR - Assessment report - Variation (PDF/1.82 MB)

CHMP post-authorisation summary of positive opinion for Nordimet (II-27) (PDF/125.51 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

Related information

Related content

How useful was this page?