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 31/10/2019

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
9
Date of issue of marketing authorisation valid throughout the European Union
18/08/2016
Contact address
Siriusdreef 22
NL-2132 WT Hoofddorp
The Netherlands

Product information

17/10/2019 Nordimet - EMEA/H/C/003983 - A31/0006

Contents

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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

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