Unia Europejska - hiszpański - EMA (European Medicines Agency)

sandoz gmbh - adalimumab - arthritis, rheumatoid; arthritis, psoriatic; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; arthritis, juvenile rheumatoid; crohn disease; skin diseases, papulosquamous - inmunosupresores - rheumatoid arthritishyrimoz 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. hyrimoz puede ser administrado como monoterapia en caso de intolerancia al metotrexato o cuando el tratamiento continuado con metotrexato es inapropiado. adalimumab ha demostrado reducir la tasa de progresión del daño articular medido por rayos x y para mejorar la función física, cuando se administra en combinación con metotrexato. juvenile idiopathic arthritis- polyarticular juvenile idiopathic arthritishyrimoz 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). hyrimoz puede ser administrado como monoterapia en caso de intolerancia al metotrexato o cuando el tratamiento continuado con metotrexato es inapropiado. adalimumab no ha sido estudiado en pacientes menores de 2 años. - enthesitis-related arthritishyrimoz 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)hyrimoz 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 ashyrimoz 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. psoriatic arthritishyrimoz 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 ha demostrado reducir la tasa de progresión de periféricos daño articular medido por rayos x en pacientes con poliarticular simétrica subtipos de la enfermedad y mejorar la función física. psoriasishyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasishyrimoz 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)hyrimoz 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. crohn’s diseasehyrimoz 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 diseasehyrimoz 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.  paediatric ulcerative colitishyrimoz 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. ulcerative colitishyrimoz 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. uveitishyrimoz 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 uveitishyrimoz 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.

Unia Europejska - hiszpański - 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 - inmunosupresores - 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. adalimumab ha demostrado reducir la tasa de progresión del daño articular medido por rayos x y para mejorar la función física, cuando se administra en combinación con metotrexato. 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. adalimumab no ha sido estudiado en pacientes menores de 2 años. 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. adalimumab ha demostrado reducir la tasa de progresión de periféricos daño articular medido por rayos x en pacientes con poliarticular simétrica subtipos de la enfermedad (ver sección 5. 1) y para mejorar la función física. 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 y 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.

Unia Europejska - hiszpański - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - adalimumab - spondylitis, ankylosing; arthritis, juvenile rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; arthritis, rheumatoid - inmunosupresores - por favor, consulte el documento de información del producto.

Unia Europejska - hiszpański - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; spondylitis, ankylosing; crohn disease; colitis, ulcerative; hidradenitis suppurativa; psoriasis; arthritis, rheumatoid - inmunosupresores - por favor refiérase a la sección 4. 1 del resumen de las características del producto en el documento de información del producto.

Unia Europejska - hiszpański - EMA (European Medicines Agency)

abbott laboratories ltd. - adalimumab - spondylitis, ankylosing; arthritis, rheumatoid; arthritis, psoriatic; crohn disease - inmunosupresores - reumatoide arthritistrudexa en combinación con metotrexato, está indicado para:el tratamiento de moderada a severa, artritis reumatoide activa en pacientes adultos cuando la respuesta a la enfermedad-modificación de las drogas anti-reumáticas, incluyendo metotrexato ha sido insuficiente. el tratamiento de graves, activa y progresiva de la artritis reumatoide en adultos no tratados previamente con metotrexato. trudexa puede ser administrado como monoterapia en caso de intolerancia al metotrexato o cuando el tratamiento continuado con metotrexato es inapropiado. trudexa ha demostrado reducir la tasa de progresión del daño articular medido por rayos x y para mejorar la función física, cuando se administra en combinación con metotrexato. psoriásica arthritistrudexa está indicado para el tratamiento de activo y progresivo de la artritis psoriásica en adultos cuando la respuesta a la anterior modificación de la enfermedad reumática de la terapia de drogas ha sido insuficiente. la espondilitis spondylitistrudexa está indicado para el tratamiento de adultos con espondilitis anquilosante activa grave que han tenido una respuesta inadecuada a la terapia convencional. la enfermedad de crohn diseasetrudexa está indicado para el tratamiento de graves, enfermedad de crohn activa, en pacientes que no han respondido a pesar de un completo y adecuado curso de la terapia con corticosteroides y/o un inmunosupresor; o que son intolerantes o tienen contraindicaciones médicas para este tipo de terapias. para el tratamiento de inducción, trudexa debe administrarse en combinación con cortiocosteroids. trudexa puede ser administrado como monoterapia en caso de intolerancia a los corticosteroides o cuando el tratamiento continuado con corticosteroides es la adecuada (véase la sección 4.

Unia Europejska - hiszpański - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - adalimumab - hidradenitis suppurativa; arthritis, psoriatic; psoriasis; crohn disease; arthritis, juvenile rheumatoid; uveitis; arthritis, rheumatoid; colitis, ulcerative; spondylitis, ankylosing - inmunosupresores - por favor refiérase a la sección 4. 1 del resumen de las características del producto en el documento de información del producto.

Unia Europejska - hiszpański - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - esclerosis múltiple - inmunosupresores selectivos - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 y 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Unia Europejska - hiszpański - EMA (European Medicines Agency)

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - inmunosupresores - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 y 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.

Unia Europejska - hiszpański - EMA (European Medicines Agency)

alexion europe sas - eculizumab - hemoglobinuria, paroxística - inmunosupresores - soliris está indicado en adultos y niños para el tratamiento de:la hemoglobinuria paroxística nocturna (hpn). evidencia de beneficio clínico se ha demostrado en pacientes con hemólisis con síntoma clínico(s) indicativo de la alta actividad de la enfermedad, independientemente de los antecedentes de transfusión (véase la sección 5. atípico síndrome hemolítico urémico (ahus). soliris está indicado en adultos para el tratamiento de:miastenia gravis generalizada refractaria (gmg) en los pacientes que son anti-receptor de acetilcolina (achr) anticuerpo-positivos (véase la sección 5. neuromielitis óptica trastorno del espectro (nmosd) en los pacientes que están en contra de la acuaporina-4 (aqp4) anticuerpo-positivos con un curso recidivante de la enfermedad.

Unia Europejska - hiszpański - EMA (European Medicines Agency)

amgen technology (ireland) uc - eculizumab - hemoglobinuria, paroxística - inmunosupresores - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). evidencia de beneficio clínico se ha demostrado en pacientes con hemólisis con síntoma clínico(s) indicativo de la alta actividad de la enfermedad, independientemente de los antecedentes de transfusión (véase la sección 5.