Nordimet

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methotrexate

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.

This EPAR was last updated on 28/02/2022

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
16
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

24/02/2022 Nordimet - EMEA/H/C/003983 - IB/0024

Product information documents contain:

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.

Assessment history

Changes since initial authorisation of medicine

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