Tunísia - francês - Ministère de la Santé, Direction de l'inspection Pharmaceutique

roche pharma (schweiz) ag - tacilizumab - solution injectable pour perfusion - 200 mg/10 ml - antineoplasiques et immunomodulateurs - immunosuppresseurs - traitement de la polyarthrite rhumatoïde active de forme modérée à sévère chez les patients adultes n'ayant pas présenté une réponse suffisante au traitement par dmard ou par inhibiteurs du facteur de nécrose tumorale (tnf). actemra peut être utilisé en monothérapie ou en combinaison avec du méthotrexate (mtx) et/ou d'autres dmard usuels.

União Europeia - francês - EMA (European Medicines Agency)

pfizer europe ma eeig  - adalimumab - arthritis, rheumatoid; arthritis, psoriatic; psoriasis; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; crohn disease; arthritis, juvenile rheumatoid - immunosuppresseurs - rhumatoïde arthritisamsparity en association avec le méthotrexate, est indiqué pour:le traitement de la forme modérée à grave, la polyarthrite rhumatoïde active chez l'adulte lorsque la réponse à la maladie-antirhumatismaux médicaments, y compris le méthotrexate a été insuffisante. le traitement de sévère, active et progressive de la polyarthrite rhumatoïde chez les adultes non précédemment traités par le méthotrexate. amsparity peut être administré en monothérapie en cas d'intolérance au méthotrexate ou lorsque la poursuite du traitement avec le méthotrexate est inapproprié. l'adalimumab a été montré pour réduire le taux de progression des lésions articulaires mesurés par radiographie et pour améliorer la fonction physique, lorsqu'il est administré en association avec le méthotrexate. juvénile idiopathique arthritispolyarticular arthrite juvénile idiopathique amsparity en association avec le méthotrexate est indiqué pour le traitement des actifs polyarticular arthrite juvénile idiopathique, chez les patients à partir de l'âge de 2 ans qui ont eu une réponse inadéquate à un ou plusieurs disease-modifying anti-rheumatic drugs (armm). amsparity peut être administré en monothérapie en cas d'intolérance au méthotrexate ou lorsque la poursuite du traitement avec le méthotrexate est inapproprié. l'adalimumab n'a pas été étudié chez les patients âgés de moins de 2 ans. l'arthrite avec enthésite amsparity est indiqué pour le traitement des actifs, ce type d'arthrite chez les patients de 6 ans et plus, qui ont eu une réponse inadéquate ou une intolérance au traitement habituel. axial spondyloarthritisankylosing de spondylarthrite ankylosante (sa) amsparity est indiqué pour le traitement des adultes atteints de graves actif de la spondylarthrite ankylosante qui ont eu une réponse inadéquate au traitement conventionnel. imagerie de la spondylarthrite axiale sans signes radiographiques de amsparity est indiqué pour le traitement des adultes atteints de graves imagerie de la spondylarthrite axiale sans signes radiographiques de comme mais avec des signes objectifs d'inflammation par une élévation de la crp et/ou l'irm, qui ont eu une réponse inadéquate ou une intolérance aux non-stéroïdiens anti-inflammatoires non stéroïdiens (ains). psoriasique arthritisamsparity est indiqué pour le traitement des actifs et progressive de l'arthrite psoriasique chez l'adulte lorsque la réponse à la précédente disease-modifying anti-rheumatic drug therapy a été insuffisante. l'adalimumab a été montré pour réduire le taux de progression de l'atteinte articulaire périphérique tel que mesuré par rayons x dans les patients avec polyarticular symétrique sous-types de la maladie et pour améliorer la fonction physique. psoriasisamsparity est indiqué pour le traitement de la forme modérée à sévère de psoriasis en plaques chronique chez les patients adultes qui sont des candidats pour la thérapie systémique. pédiatrie plaque psoriasisamsparity est indiqué pour le traitement des graves de psoriasis chronique en plaques chez les enfants et les adolescents à partir de 4 ans qui ont eu une réponse inadéquate ou inappropriée des candidats pour la thérapie topique et photothérapies. l'hidradénite suppurativaamsparity est indiqué pour le traitement de active modérée à sévère de l'hidradénite suppurée (hs) (acné inversa) chez les adultes et les adolescents à partir de 12 ans présentant une réponse inadéquate à la classique systémique thérapie hs. la maladie de crohn diseaseamsparity est indiqué pour le traitement de modérément à sévèrement active de la maladie de crohn, chez les patients adultes qui n'ont pas répondu malgré une pleine et adéquate cours du traitement avec un corticostéroïde et/ou un immunosuppresseur; ou qui sont intolérants ou d'avoir de contre-indications médicales pour ces thérapies. de pédiatrie de la maladie de crohn diseaseamsparity est indiqué pour le traitement de modérément à sévèrement active de la maladie de crohn chez les patients pédiatriques (à partir de 6 ans) qui ont eu une réponse inadéquate au traitement conventionnel, y compris principal de la thérapie nutritionnelle et un corticoïde et/ou un immunomodulateur, ou qui sont intolérants ou présentent des contre-indications pour ces thérapies. ulcéreuse colitisamsparity est indiqué pour le traitement de modérément à sévèrement active de la colite ulcéreuse chez les patients adultes ayant eu une réponse inadéquate à un traitement conventionnel comprenant les corticoïdes et la 6-mercaptopurine (6-mp) ou l'azathioprine (aza), ou qui sont intolérants ou d'avoir de contre-indications médicales pour ces thérapies. uveitisamsparity est indiqué pour le traitement de la non-infectieux intermédiaire, postérieure et panuveitis chez les patients adultes ayant eu une réponse inadéquate aux corticoïdes, chez les patients dans le besoin de corticoïdes d'épargne, ou chez qui le traitement par corticoïdes est inapproprié. l'adolescent hidradénite suppurativaamsparity est indiqué pour le traitement de active modérée à sévère de l'hidradénite suppurée (hs) (acné inversa) chez les adolescents à partir de 12 ans présentant une réponse inadéquate à la classique systémique thérapie hs. pédiatrie uveitisamsparity est indiqué pour le traitement de pédiatrie chronique non infectieuse de l'uvéite antérieure chez les patients à partir de l'âge de 2 ans qui ont eu une réponse inadéquate ou une intolérance aux traitements conventionnels ou chez qui la thérapie conventionnelle est inapproprié.

União Europeia - francês - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - adalimumab - arthritis, rheumatoid; arthritis, psoriatic; psoriasis; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; crohn disease; arthritis, juvenile rheumatoid - immunosuppresseurs - rheumatoid arthritisyuflyma 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. yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. l'adalimumab a été montré pour réduire le taux de progression des lésions articulaires mesurés par radiographie et pour améliorer la fonction physique, lorsqu'il est administré en association avec le méthotrexate. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritisyuflyma 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). yuflyma 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. l'adalimumab n'a pas été étudié chez les patients âgés de moins de 2 ans. enthesitis-related arthritisyuflyma 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. axial spondyloarthritisankylosing spondylitis (as)yuflyma 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 asyuflyma 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 arthritisyuflyma 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. l'adalimumab a été montré pour réduire le taux de progression de l'atteinte articulaire périphérique tel que mesuré par rayons x dans les patients avec polyarticular symétrique sous-types de la maladie (voir la section 5. 1) et pour améliorer la fonction physique. psoriasisyuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasisyuflyma 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)yuflyma 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 et 5. crohn’s diseaseyuflyma 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 diseaseyuflyma 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 colitisyuflyma 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. paediatric ulcerative colitisyuflyma is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitisyuflyma 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 uveitisyuflyma 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.

União Europeia - francês - EMA (European Medicines Agency)

stada arzneimittel ag - adalimumab - arthritis, psoriatic; arthritis, juvenile rheumatoid; arthritis, rheumatoid; colitis, ulcerative; crohn disease; hidradenitis suppurativa; psoriasis; spondylitis, ankylosing; uveitis - immunosuppresseurs - rheumatoid arthritishukyndra 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 (dmards) including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. l'adalimumab a été montré pour réduire le taux de progression des lésions articulaires mesurés par radiographie et pour améliorer la fonction physique, lorsqu'il est administré en association avec le méthotrexate. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritishukyndra 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 dmard. hukyndra 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. l'adalimumab n'a pas été étudié chez les patients âgés de moins de 2 ans. enthesitis-related arthritishukyndra 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. axial spondyloarthritisankylosing spondylitis (as)hukyndra is indicated for the treatment of adults with severe active as who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of ashukyndra 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 nonsteroidal anti-inflammatory drugs (nsaids). psoriatic arthritishukyndra is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous dmard therapy has been inadequate. l'adalimumab a été montré pour réduire le taux de progression de l'atteinte articulaire périphérique tel que mesuré par rayons x dans les patients avec polyarticular symétrique sous-types de la maladie (voir la section 5. 1) et pour améliorer la fonction physique. psoriasishukyndra is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasishukyndra 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)hukyndra is indicated for the treatment of active moderate to severe hs (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 et 5. crohn’s diseasehukyndra 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 diseasehukyndra 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 colitishukyndra 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. paediatric ulcerative colitishukyndra is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitishukyndra 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 uveitishukyndra 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.

União Europeia - francês - EMA (European Medicines Agency)

stada arzneimittel ag - adalimumab - arthritis, rheumatoid; arthritis, juvenile rheumatoid; spondylitis, ankylosing; arthritis, psoriatic; psoriasis; hidradenitis suppurativa; crohn disease; colitis, ulcerative; uveitis - immunosuppresseurs - rheumatoid arthritislibmyris 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 (dmards) including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. l'adalimumab a été montré pour réduire le taux de progression des lésions articulaires mesurés par radiographie et pour améliorer la fonction physique, lorsqu'il est administré en association avec le méthotrexate. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritislibmyris 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 dmard. libmyris 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. l'adalimumab n'a pas été étudié chez les patients âgés de moins de 2 ans. enthesitis-related arthritislibmyris 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 spondyloarthritisankylosing spondylitis (as)libmyris is indicated for the treatment of adults with severe active as who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of aslibmyris 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 nonsteroidal anti-inflammatory drugs (nsaids). psoriatic arthritislibmyris is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous dmard therapy has been inadequate. l'adalimumab a été montré pour réduire le taux de progression de l'atteinte articulaire périphérique tel que mesuré par rayons x dans les patients avec polyarticular symétrique sous-types de la maladie et pour améliorer la fonction physique. psoriasislibmyris is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasislibmyris 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)libmyris is indicated for the treatment of active moderate to severe hs (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 et 5. crohn’s diseaselibmyris 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 diseaselibmyris 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 colitislibmyris 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. paediatric ulcerative colitislibmyris is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitislibmyris 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 uveitislibmyris 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.

Bélgica - francês - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pfizer sa-nv - 50 mg/ml - solution à diluer pour perfusion - 50 mg/ml - immunoglobuline humaine anti-t-lymphocyte (origine chevaux) 50 mg/ml - antilymphocyte immunoglobulin (horse)

União Europeia - francês - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizumab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - immunosuppresseurs - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx. - the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tocilizumab 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. tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx. tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.

Bélgica - francês - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

impexeco - ginkgo biloba, extrait - comprimé pelliculé - 120 mg - ginkgo biloba, extrait 120 mg - other peripheral vasodilators; antivertigo preparations; other anti-dementia drugs

Bélgica - francês - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

orifarm - ginkgo biloba, extrait - comprimé pelliculé - 120 mg - ginkgo biloba, extrait 120 mg - other peripheral vasodilators; antivertigo preparations; other anti-dementia drugs

União Europeia - francês - EMA (European Medicines Agency)

teva pharma b.v. - rivastigmine - dementia; alzheimer disease; parkinson disease - anticholinestérases - traitement symptomatique de la démence d'alzheimer légère à modérément sévère. traitement symptomatique des formes légères à modérément sévères de démence chez les patients atteints de la maladie de parkinson idiopathique.