Uniunea Europeană - spaniolă - EMA (European Medicines Agency)

janssen-cilag international n.v. - teclistamab - mieloma múltiple - agentes antineoplásicos - tecvayli is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Uniunea Europeană - spaniolă - EMA (European Medicines Agency)

novartis europharm limited - ruxolitinib (como fosfato) - myeloproliferative disorders; polycythemia vera; graft vs host disease - agentes antineoplásicos - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. la policitemia vera (pv)jakavi está indicado para el tratamiento de pacientes adultos con policitemia vera que son resistentes o intolerantes a la hidroxiurea. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.

Uniunea Europeană - spaniolă - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - agentes antineoplásicos - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. , as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Uniunea Europeană - spaniolă - EMA (European Medicines Agency)

akcea therapeutics ireland limited - volanesorsen de sodio - hiperlipoproteinemia tipo i - otros agentes modificadores de los lípidos - waylivra está indicado como adyuvante a la dieta en pacientes adultos con organismos genéticamente confirmado familiar chylomicronemia síndrome de down (fcs) y en alto riesgo de pancreatitis, en los cuales la respuesta a la dieta de triglicéridos y la reducción de la terapia ha sido insuficiente.

Spania - spaniolă - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

floris holding b.v. - acepromazina maleato - gel oral - acepromazina maleato 47,50 - acepromazina - perros

Spania - spaniolă - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

bioveta a.s. - acepromazina maleato - gel oral - acepromazina maleato 47,5 - acepromazina - perros; caballos no destinados a consumo humano

Spania - spaniolă - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

virbac - aglepristona - soluciÓn inyectable - aglepristona 30 - aglepristona - perras gestantes

Uniunea Europeană - spaniolă - EMA (European Medicines Agency)

cheplapharm arzneimittel gmbh - capecitabina - colonic neoplasms; breast neoplasms; colorectal neoplasms; stomach neoplasms - agentes antineoplásicos - xeloda está indicado para el tratamiento adyuvante de pacientes después de la cirugía de la fase iii (estadio de dukes c) cáncer de colon. xeloda está indicado para el tratamiento de cáncer colorrectal metastásico. xeloda está indicado para el tratamiento de primera línea del cáncer gástrico avanzado en combinación con un platino-basada en régimen de. xeloda en combinación con docetaxel está indicado para el tratamiento de pacientes con localmente avanzado o metastásico, cáncer de mama, después del fracaso de la quimioterapia citotóxica. la terapia anterior debería haber incluido una antraciclina. xeloda también está indicado como monoterapia para el tratamiento de pacientes con localmente avanzado o metastásico, cáncer de mama, después del fracaso de los taxanos y una quimioterapia con antraciclina régimen o para quienes más antraciclina terapia no está indicado.

Uniunea Europeană - spaniolă - EMA (European Medicines Agency)

valneva austria gmbh - covid-19 vaccine (inactivated, adjuvanted, adsorbed) - covid-19 virus infection - vacunas - covid-19 vaccine (inactivated, adjuvanted) valneva is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 to 50 years of age.  the use of this vaccine should be in accordance with official recommendations.

Uniunea Europeană - spaniolă - EMA (European Medicines Agency)

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - inmunosupresores - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.