Avrupa Birliği - İspanyolca - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - anakinra - arthritis, rheumatoid; covid-19 virus infection - inmunosupresores - la artritis reumatoide (ar)kineret está indicado en adultos para el tratamiento de los signos y síntomas de la ar en combinación con metotrexato, con una respuesta inadecuada a metotrexato solo. covid-19kineret is indicated for the treatment of coronavirus disease 2019 (covid-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (supar) ≥ 6 ng/ml. periodic fever syndromeskineret is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above:cryopyrin-associated periodic syndromes (caps)kineret is indicated for the treatment of caps, including:neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca)muckle-wells syndrome (mws)familial cold autoinflammatory syndrome (fcas)familial mediterranean fever (fmf)kineret is indicated for the treatment of familial mediterranean fever (fmf). kineret debe administrarse en combinación con colchicina, si es apropiado. still’s diseasekineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of still’s disease, including systemic juvenile idiopathic arthritis (sjia) and adult-onset still’s disease (aosd), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (nsaids) or glucocorticoids. kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (dmards).

Avrupa Birliği - İspanyolca - EMA (European Medicines Agency)

les laboratoires servier - trifluridine, tipiracil clorhidrato de - neoplasias colorrectales - agentes antineoplásicos - colorectal cancerlonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (crc) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and/or anti-egfr agents. lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (crc) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and anti egfr agentsgastric cancerlonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

Avrupa Birliği - İspanyolca - EMA (European Medicines Agency)

astrazeneca ab - olaparib - neoplasmas ováricos - agentes antineoplásicos - ovario cancerlynparza está indicado como monoterapia para el:tratamiento de mantenimiento de pacientes adultos con avanzada (figo etapas iii y iv) en los genes brca1/2 mutación de la línea germinal (y/o somáticas) de alto grado epitelial de ovario, de trompa de falopio o peritoneal primario de cáncer que están en la respuesta (parcial o completa) después de la finalización de la primera línea de quimioterapia basada en platino. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 y 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. los pacientes deben haber sido tratados previamente con una antraciclina y un taxano en el (neo)adyuvante o metastásico (a menos que los pacientes no eran adecuadas para estos tratamientos (véase la sección 5. los pacientes con receptores hormonales (rh) positivo de cáncer de mama deben también han progresado en o después de antes de la terapia endocrina, o ser considerados no aptos para la terapia endocrina. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Avrupa Birliği - İspanyolca - EMA (European Medicines Agency)

takeda pharma a/s - citrato de ixazomib - mieloma múltiple - agentes antineoplásicos - ninlaro en combinación con lenalidomida y dexametasona está indicado para el tratamiento de pacientes adultos con mieloma múltiple que han recibido al menos una terapia previa.

Avrupa Birliği - İspanyolca - EMA (European Medicines Agency)

les laboratoires servier - irinotecan anhydrous free-base - neoplasias pancreáticas - agentes antineoplásicos - tratamiento del adenocarcinoma metastásico del páncreas, en combinación con 5 fluorouracilo (5 fu) y leucovorina (lv), en pacientes adultos que han progresado después de la terapia basada en gemcitabina.

Avrupa Birliği - İspanyolca - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - venetoclax - leucemia, linfocítica, crónica, b-cell - agentes antineoplásicos - venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. venclyxto in combination with rituximab is indicated for the treatment of adult patients with cll who have received at least one prior therapy. venclyxto monotherapy is indicated for the treatment of cll:- in the presence of 17p deletion or tp53 mutation in adult patients who are unsuitable for or have failed a b cell receptor pathway inhibitor, or- in the absence of 17p deletion or tp53 mutation in adult patients who have failed both chemoimmunotherapy and a b-cell receptor pathway inhibitor. venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly  diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.

Avrupa Birliği - İspanyolca - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - la talidomida - mieloma múltiple - inmunosupresores - thalidomide bms in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. thalidomide bms is prescribed and dispensed according to the thalidomide celgene pregnancy prevention programme (see section 4.

Avrupa Birliği - İspanyolca - EMA (European Medicines Agency)

recordati rare diseases - el ibuprofeno - ductus arteriosus, patente - terapia cardiaca - tratamiento de un ductus arterioso permeable hemodinámicamente significativo en recién nacidos prematuros menores de 34 semanas de edad gestacional.

Avrupa Birliği - İspanyolca - EMA (European Medicines Agency)

roche registration gmbh  - pertuzumab - neoplasias de la mama - antineoplastic agents, monoclonal antibodies - el cáncer de mama metastásico:perjeta es indicado para su uso en combinación con trastuzumab y docetaxel en pacientes adultos con her2-positivo metastásico o localmente recurrente no resecables de cáncer de mama, que no han recibido previamente la terapia anti-her2 o quimioterapia para su enfermedad metastásica. tratamiento neoadyuvante del cáncer de mama:perjeta es indicado para su uso en combinación con trastuzumab y quimioterapia para el tratamiento neoadyuvante de pacientes adultos con her2-positivo, localmente avanzado, inflamatoria, o etapa temprana de cáncer de mama en alto riesgo de recurrencia.

Avrupa Birliği - İspanyolca - EMA (European Medicines Agency)

schering-plough europe - posaconazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimicóticos para uso sistémico - posaconazole sp está indicado para su uso en el tratamiento de las siguientes infecciones fúngicas en adultos (ver sección 5).. 1):- la aspergilosis invasiva en pacientes con enfermedad refractaria a la anfotericina b, itraconazol o en pacientes que son intolerantes a estos medicamentos;- fusariosis en pacientes con enfermedad refractaria a la anfotericina b, o en pacientes que son intolerantes a la de la anfotericina b;- chromoblastomycosis y mycetoma en pacientes con enfermedad refractaria a itraconazol o en pacientes que son intolerantes a la de itraconazol;- la coccidioidomicosis en pacientes con enfermedad refractaria a la anfotericina b, itraconazol o fluconazol o en pacientes que son intolerantes a estos medicamentos;- candidiasis orofaríngea: como terapia de primera línea en los pacientes que tienen enfermedad grave o que están inmunocomprometidos, en los que la respuesta a la terapia tópica se espera que para ser pobre. la refractariedad se define como la progresión de la infección o el fracaso a mejorar después de un mínimo de 7 días antes de la dosis terapéutica de un eficaz tratamiento antifúngico. posaconazol sp también está indicado para la profilaxis de infecciones fúngicas invasivas en los siguientes pacientes:- pacientes que reciben la remisión de la inducción de la quimioterapia para la leucemia mielógena aguda (lma) o los síndromes mielodisplásicos (smd) espera que el resultado de la neutropenia prolongada y que areat alto riesgo de desarrollar infecciones fúngicas invasivas;- trasplante de células madre hematopoyéticas (hsct) que son sometidos a altas dosis de terapia inmunosupresora para la enfermedad de injerto contra huésped y que están en alto riesgo de desarrollar infecciones fúngicas invasivas.