Europska Unija - španjolski - 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 - inmunosupresores - reumatoide arthritisamsparity 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. amsparity 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. idiopática juvenil arthritispolyarticular artritis idiopática juvenil amsparity en combinación con metotrexato, está indicado para el tratamiento de los activos de la artritis reumatoide juvenil poliarticular, en pacientes a partir de los 2 años de edad que han tenido una respuesta inadecuada a uno o más modificadores de la enfermedad, las drogas anti-reumáticas (dmard). amsparity 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. la artritis relacionada con entesitis amsparity está indicado para el tratamiento de los activos de la artritis relacionada con entesitis en pacientes de 6 años de edad y mayores, que han tenido una respuesta inadecuada a, o que son intolerantes, terapia convencional. axial spondyloarthritisankylosing anquilosante (as) amsparity está indicado para el tratamiento de adultos con espondilitis anquilosante activa grave que han tenido una respuesta inadecuada a la terapia convencional. axial spondyloarthritis sin evidencia radiográfica de como amsparity está indicado para el tratamiento de adultos con graves axial spondyloarthritis sin evidencia radiográfica de como, pero con el objetivo de signos de la inflamación mediante la elevación de la pcr y/o resonancia magnética, que han tenido una respuesta inadecuada o intolerancia a antiinflamatorios no esteroideos-inflamatorios no esteroideos (aine). psoriásica arthritisamsparity 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. 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. psoriasisamsparity está indicado para el tratamiento de moderada a severa psoriasis en placas crónica en pacientes adultos que son candidatos para la terapia sistémica. pediátrica de la placa psoriasisamsparity está indicado para el tratamiento de la severa psoriasis en placas crónica en niños y adolescentes desde los 4 años de edad que han tenido una respuesta inadecuada o inapropiada candidatos para la terapia tópica y phototherapies. hidradenitis suppurativaamsparity está indicado para el tratamiento de la activa de moderada a grave de la hidradenitis supurativa (hs) (acné inversa) en adultos y adolescentes a partir de 12 años de edad con una respuesta inadecuada a la convencional sistémica hs terapia. la enfermedad de crohn diseaseamsparity está indicado para el tratamiento de moderada a gravemente activa la enfermedad de crohn, en pacientes adultos 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. de crohn pediátrica diseaseamsparity está indicado para el tratamiento de moderada a gravemente activa la enfermedad de crohn en pacientes pediátricos (de 6 años de edad) que han tenido una respuesta inadecuada a la terapia convencional, incluidos los de terapia de nutrición y un corticosteroide y/o un inmunomodulador, o que son intolerantes o tienen contraindicaciones para este tipo de terapias. la colitis colitisamsparity está indicado para el tratamiento de moderada a gravemente activa la colitis ulcerosa en pacientes adultos que han tenido una respuesta inadecuada a la terapia convencional, incluidos corticosteroides y 6-mercaptopurina (6-mp) o azatioprina (aza), o que son intolerantes o tienen contraindicaciones médicas para este tipo de terapias. uveitisamsparity está indicado para el tratamiento de la no-infecciosas intermedia, posterior y panuveitis en pacientes adultos que han tenido una respuesta inadecuada al tratamiento con corticosteroides, en los pacientes en necesidad de corticosteroides ahorradores, o en los que el tratamiento con corticosteroides es inapropiado. los adolescentes hidradenitis suppurativaamsparity está indicado para el tratamiento de la activa de moderada a grave de la hidradenitis supurativa (hs) (acné inversa) en adolescentes de 12 años de edad con una respuesta inadecuada a la convencional sistémica hs terapia. pediátrica uveitisamsparity está indicado para el tratamiento de pediátrica de enfermedades crónicas no infecciosas uveítis anterior en pacientes de 2 años de edad que han tenido una respuesta inadecuada o intolerancia a la terapia convencional, o en los que el tratamiento convencional es inadecuado.

Europska Unija - španjolski - 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.

Europska Unija - španjolski - 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 - inmunosupresores - 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. 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 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. adalimumab no ha sido estudiado en pacientes menores de 2 años. 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. 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. 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 y 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.

Europska Unija - španjolski - 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 - inmunosupresores - 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. 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 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. adalimumab no ha sido estudiado en pacientes menores de 2 años. 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. 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. 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 y 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.

Urugvaj - španjolski - Ministerio de Salud (Dirección Oficina Central)

abbvie - comprimido recubierto - adalimumab 20 mg/0,2 ml inyectable

Europska Unija - španjolski - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - azacitidina - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - agentes antineoplásicos - vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with: intermediate 2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30 % blasts and multi-lineage dysplasia, according to world health organisation (who) classification. vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for hsct with aml with >30% marrow blasts according to the who classification.