Nordimet
methotrexate
Table of contents
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.
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List item
Nordimet : EPAR - Medicine overview (PDF/80.88 KB)
First published: 29/09/2016
Last updated: 31/10/2019 -
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List item
Nordimet : EPAR - Risk-management-plan summary (PDF/171.42 KB)
First published: 02/02/2021
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) |
|
| Anatomical therapeutic chemical (ATC) code |
L04AX03
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Nordic Group B.V.
|
| Revision |
18
|
| Date of issue of marketing authorisation valid throughout the European Union |
18/08/2016
|
| Contact address |
Siriusdreef 41 |
Product information
13/03/2023 Nordimet - EMEA/H/C/003983 - N/0028
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.
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.