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Adalimumab

Also known as: Humira · Amgevita · Imraldi · Hefiya · Hyrimoz · Hulio · Idacio · Amsparity · Yuflyma · Libmyris

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In short

In the United States, adalimumab-aacf is a tumor necrosis factor blocker indicated for reducing signs and symptoms, inhibiting structural damage progression, and improving physical function in adults with moderately to severely active rheumatoid arthritis or active psoriatic arthritis. It is also indicated in the United States for moderately to severely active polyarticular juvenile idiopathic arthritis in patients aged 2 and older, active ankylosing spondylitis in adults, and moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Additionally, it is indicated in the United States for moderately to severely active Crohn's disease in patients aged 6 and older, and moderately to severely active ulcerative colitis in adults, though its effectiveness is not established in patients who lost response to or were intolerant to other tumor necrosis factor blockers. The medicine is also listed by cited sources as having approved uses for Crohn disease, ulcerative colitis, and psoriasis.

From: 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
327361 adalimumab
EMA
EMEA/H/C/000481, EMEA/H/C/004212, EMEA/H/C/004279, EMEA/H/C/004865, EMEA/H/C/004320, EMEA/H/C/004429, EMEA/H/C/004475, EMEA/H/C/004879, EMEA/H/C/005188, EMEA/H/C/005947, EMEA/H/C/005548

Official indications

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

FDA (USA) Adalimumab-aacf

1 INDICATIONS AND USAGE Adalimumab-aacf is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA) ( 1.1 ): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. Juvenile Idiopathic Arthritis (JIA) ( 1.2 ): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. Psoriatic Arthritis (PsA) ( 1.3 ): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. Ankylosing Spondylitis (AS) ( 1.4 ): reducing signs and symptoms in adult patients with active AS. Crohn's Disease (CD) ( 1.5 ): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. Ulcerative Colitis (UC) ( 1.6 ): treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. Plaque Psoriasis (Ps) ( 1.7 ): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Hidradenitis Suppurativa (HS) ( 1.8 ): treatment of moderate to severe hidradenitis suppurativa in adult patients. Uveitis (UV) ( 1.9 ): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. 1.1 Rheumatoid Arthritis Adalimumab-aacf is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Adalimumab-aacf can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis Adalimumab-aacf is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Adalimumab-aacf can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis Adalimumab-aacf is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Adalimumab-aacf can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis Adalimumab-aacf is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn's Disease Adalimumab-aacf is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis Adalimumab-aacf is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies ( 14.7 )] . 1.7 Plaque Psoriasis Adalimumab-aacf is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Adalimumab-aacf should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions ( 5 )] . 1.8 Hidradenitis Suppurativa Adalimumab-aacf is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. 1.9 Uveitis Adalimumab-aacf is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

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

Document date: 20260108 · Official document →

EMA (EU) Humira

Please refer to the product information document.

Source: European Medicines Agency (EMA), Humira — EPAR, 14/10/2026. © European Medicines Agency.

Document date: 14/10/2026 · Official document →

Related terms in the cited sources

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External resources

Questions

What is Adalimumab approved for in the European Union?

Please refer to the product information document. (Source: European Medicines Agency (EMA), Humira — EPAR, 14/10/2026. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Data provided by the U.S. Food and Drug Administration.
  • 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.
  • 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), Humira — EPAR, 14/10/2026. © European Medicines Agency.

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