Amsparity

À quoi sert Amsparity ?

Amsparity est indiqué pour traiter la polyarthrite rhumatoïde, le rhumatisme psoriasique, le psoriasis, spondylarthrite ankylosante, l’uvéite, l’hidradénite suppurée, la rectocolite hémorragique, la maladie de Crohn et l’arthrite juvénile 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 Amsparity est-il autorisé ?

Domaines thérapeutiques EMA de type maladie ou condition

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

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

Indication réglementaire officielle

Rheumatoid arthritis Amsparity 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. Amsparity can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Amsparity 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). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Amsparity 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. Axial spondyloarthritis Ankylosing spondylitis (AS) Amsparity 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 Amsparity 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 (NSAIDs). Psoriatic arthritis Amsparity 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. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Psoriasis Amsparity is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Amsparity 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 Amsparity is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Crohn’s disease Amsparity 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 Amsparity 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 Amsparity 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 Amsparity 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. Adolescent hidradenitis suppurativa Amsparity is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Paediatric uveitis Amsparity 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.

  Amsparity : EPAR - All authorised presentations ↗
• Rapport d’évaluation

  Rapport scientifique public associé à l’autorisation.

  Amsparity : EPAR - Public assessment report ↗
• Aperçu EPAR

  Résumé public de l’évaluation européenne du médicament.

  Amsparity : EPAR - Medicine overview ↗
• Plan de gestion des risques

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

  Amsparity : EPAR - Risk management plan ↗

Quelle est la dernière mise à jour EMA disponible ?

Le jeu EMA indique la révision 10 et une dernière mise à jour de page au 22 octobre 2025. Dernière procédure publiée affectant l’information produit : VR/0000289586.

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 : 22 octobre 2025

Quelle est sa substance active ?

• adalimumab

Informations réglementaires

Numéro de produit EMA

EMEA/H/C/004879

DCI / nom commun

adalimumab

Code ATC

L04AB04

Groupe pharmacothérapeutique

Immunosuppressants

Titulaire d’AMM

Pfizer Europe MA EEIG

Statut

Autorisé

Date d’autorisation

13 février 2020

Décision Commission (jeu EMA)

16 octobre 2025

Médicaments liés

• Amgevitaadalimumab
• Humiraadalimumab
• Yuflymaadalimumab

Retour au hub médicaments

Sources et provenance

Fournisseur

European Medicines Agency

Page source

Page médicament EMA ↗

Date source (page EMA)

22 octobre 2025

Horodatage du jeu EMA

2026-09-09T06:12:45Z

Statut (valeur EMA d’origine)

Authorised

Révision

10

Empreinte de la fiche publique

sha256:35797501a499b97fdd8ae899e571adfe414543a6b0c0aa9695b379c2adf8e1bd

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.