Amgevita

À quoi sert Amgevita ?

Amgevita est indiqué pour traiter le rhumatisme psoriasique, la rectocolite hémorragique, l’arthrite juvénile, spondylarthrite ankylosante, le psoriasis, la maladie de Crohn et la polyarthrite rhumatoïde chez les populations définies par l’EMA.

Phrase construite à partir de l’indication officielle EMA, pour une fonction de traitement. Seules les cibles directement soutenues par le texte d’indication sont listées. Les domaines thérapeutiques restent une taxonomie. Ce n’est pas une indication personnalisée.

Dans quelles maladies ou situations Amgevita est-il autorisé ?

Domaines thérapeutiques EMA de type maladie ou condition

• rhumatisme psoriasiqueEMA · Arthritis, Psoriatic
• rectocolite hémorragiqueEMA · Colitis, Ulcerative
• arthrite juvénileEMA · Arthritis, Juvenile Rheumatoid
• spondylarthrite ankylosanteEMA · Spondylitis, Ankylosing
• psoriasisEMA · Psoriasis
• maladie de CrohnEMA · Crohn Disease
• polyarthrite rhumatoïdeEMA · Arthritis, Rheumatoid

Cette liste résume les domaines thérapeutiques publiés par l’EMA et ne constitue pas l’indication réglementaire complète.

Indication réglementaire officielle

Rheumatoid arthritis Amgevita in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Amgevita reduces the rate of progression of joint damage as measured by x-ray and improves physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Amgevita in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Amgevita is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Axial spondyloarthritis Ankylosing spondylitis (AS) Amgevita is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Amgevita is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs. Psoriatic arthritis Amgevita is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Amgevita reduces the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and improves physical function. Psoriasis Amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Amgevita is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Hidradenitis suppurativa (HS) Amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2). Crohn’s disease Amgevita is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Amgevita is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Ulcerative colitis Amgevita is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Uveitis Amgevita is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis Amgevita is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Texte officiel EMA en anglais, non traduit par Medyx. Page source ↗

Information produit et documents officiels

Autres documents officiels liés

• Présentations autorisées

  Liste des présentations autorisées au niveau européen.

  Amgevita : EPAR - All Authorised presentations ↗
• Rapport d’évaluation

  Rapport scientifique public associé à l’autorisation.

  Amgevita : EPAR - Public assessment report ↗
• Aperçu EPAR

  Résumé public de l’évaluation européenne du médicament.

  Amgevita : EPAR - Summary for the public ↗
• Plan de gestion des risques

  Document décrivant les mesures de minimisation des risques publiées par l’EMA.

  Amgevita : EPAR - Risk management plan ↗

Quelle est la dernière mise à jour EMA disponible ?

Le jeu EMA indique la révision 16 et une dernière mise à jour de page au 18 août 2026. Dernière procédure publiée affectant l’information produit : V/0000361018.

Qu’est-ce qui a changé récemment ?

Aucune détection Medyx publiée pour ce médicament dans le corpus public actuel.

• Voir l’information produit EMA (dont le RCP)
• Voir le fichier de changements suivis EMA
• Dernière mise à jour EMA de la page : 18 août 2026

Quelle est sa substance active ?

• adalimumab

Informations réglementaires

Numéro de produit EMA

EMEA/H/C/004212

DCI / nom commun

adalimumab

Code ATC

L04AB04

Groupe pharmacothérapeutique

Immunosuppressants

Titulaire d’AMM

Amgen Europe B.V.

Statut

Autorisé

Date d’autorisation

21 mars 2017

Décision Commission (jeu EMA)

13 août 2026

Médicaments liés

• Amsparityadalimumab
• Humiraadalimumab
• Yuflymaadalimumab

Retour au hub médicaments

Sources et provenance

Fournisseur

European Medicines Agency

Page source

Page médicament EMA ↗

Date source (page EMA)

18 août 2026

Horodatage du jeu EMA

2026-09-09T06:12:45Z

Statut (valeur EMA d’origine)

Authorised

Révision

16

Empreinte de la fiche publique

sha256:80ea104cfd25ba0ecba19b57380a6acabb86f398e3fde076b38472161521b03c

Cette empreinte couvre la fiche publique telle qu’elle est affichée : identité EMA, substances, code ATC, domaines thérapeutiques, titulaire d’AMM, dates, révision, indication, documents liés et cas publics. Elle ne couvre pas le PDF source.