Anpheros Search · Treatment

Methotrexate

Also known as: Nordimet · Jylamvo

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In short

In the European Union, methotrexate is indicated for active rheumatoid arthritis in adults, polyarthritic forms of active, severe juvenile idiopathic arthritis in children aged 3 years and over when response to non-steroidal anti-inflammatory drugs has been inadequate, and severe, treatment-refractory, disabling psoriasis or moderate to severe plaque psoriasis in adults. European Union approvals also cover severe psoriatic arthritis in adults, maintenance treatment of acute lymphoblastic leukaemia in patients aged 3 years and over, and the induction and maintenance of remission in moderate steroid-dependent Crohn's disease in adults. In the United States, methotrexate tablets are indicated for the treatment of adults and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy maintenance regimen, adults with mycosis fungoides, and adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen. United States indications also include adults with rheumatoid arthritis, pediatric patients with polyarticular juvenile idiopathic arthritis, and adults with severe psoriasis. Methotrexate is listed by the cited source as having an approved use for psoriasis.

From: Source: European Medicines Agency (EMA), Jylamvo — EPAR, 07/09/2026. © European Medicines Agency. · Source: European Medicines Agency (EMA), Nordimet — EPAR, 07/09/2026. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
6851 methotrexate
EMA
EMEA/H/C/003983, EMEA/H/C/003756

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Jylamvo

In rheumatological and dermatological diseases Active rheumatoid arthritis in adult patients. Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate. Severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients. In oncology Maintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over.

Source: European Medicines Agency (EMA), Jylamvo — EPAR, 07/09/2026. © European Medicines Agency.

Document date: 07/09/2026 · Official document →

FDA (USA) Methotrexate

1 INDICATIONS AND USAGE Methotrexate tablets are a dihydrofolate reductase inhibitor indicated for the: Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen ( 1.1 ) Treatment of adults with mycosis fungoides ( 1.1 ) Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen ( 1.1 ) Treatment of adults with rheumatoid arthritis ( 1.2 ) Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) ( 1.3 ) Treatment of adults with severe psoriasis ( 1.4 ) 1.1 Neoplastic Diseases Methotrexate tablets are indicated for the: treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen treatment of adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen treatment of adults with relapsed or refractory non-Hodgkin lymphomas as part of a metronomic combination chemotherapy regimen 1.2 Rheumatoid Arthritis Methotrexate tablets are indicated for the treatment of adults with rheumatoid arthritis. 1.3 Polyarticular Juvenile Idiopathic Arthritis Methotrexate tablets are indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA). 1.4 Psoriasis Methotrexate tablets are indicated for the treatment of adults with severe psoriasis.

Data provided by the U.S. Food and Drug Administration.

Document date: 20260827 · Official document →

EMA (EU) Nordimet

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.

Source: European Medicines Agency (EMA), Nordimet — EPAR, 07/09/2026. © European Medicines Agency.

Document date: 07/09/2026 · Official document →

Related terms in the cited sources

Has an official indication for

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External resources

Questions

What is Methotrexate approved for in the European Union?

In rheumatological and dermatological diseases Active rheumatoid arthritis in adult patients. Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate. Severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients. In oncology Maintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over. (Source: European Medicines Agency (EMA), Jylamvo — EPAR, 07/09/2026. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • Data provided by the U.S. Food and Drug Administration.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Jylamvo — EPAR, 07/09/2026. © European Medicines Agency.
  • Source: European Medicines Agency (EMA), Nordimet — EPAR, 07/09/2026. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →