Unión Europea - español - EMA (European Medicines Agency)

novartis europharm limited  - vildagliptina, metformin hidrocloruro - diabetes mellitus, tipo 2 - drogas usadas en diabetes - zomarist is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate.

Unión Europea - español - 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.

Unión Europea - español - 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.

Unión Europea - español - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - ambrisentan - hipertensión, pulmonar - los antihipertensivos,los - volibris is indicated for treatment of pulmonary arterial hypertension (pah) in adult patients of who functional class (fc) ii to iii, including use in combination treatment (see section 5.  efficacy has been shown in idiopathic pah (ipah) and in pah associated with connective tissue disease. volibris is indicated for treatment of pah in adolescents and children (aged 8 to less than 18 years) of who functional class (fc) ii to iii including use in combination treatment. efficacy has been shown in ipah, familial, corrected congenital and in pah associated with connective tissue disease (see section 5.

Unión Europea - español - EMA (European Medicines Agency)

novartis europharm limited - vildagliptina - diabetes mellitus, tipo 2 - drogas usadas en diabetes - vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 y 5. 1 para datos disponibles sobre diferentes combinaciones).

Unión Europea - español - EMA (European Medicines Agency)

pfizer europe ma eeig - talazoparib - neoplasias de la mama - agentes antineoplásicos - talzenna está indicado como monoterapia para el tratamiento de pacientes adultos con línea germinal mutaciones brca1/2, que han her2-negativo localmente avanzado o metastásico, el cáncer de mama. patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. los pacientes con receptores hormonales (rh) positivo de cáncer de mama deben haber sido tratadas con un endocrino antes de la terapia basada en, o ser considerados no aptos para el sistema endocrino de la terapia basada en.

Unión Europea - español - EMA (European Medicines Agency)

pfizer europe ma eeig - lorlatinib - carcinoma, pulmón no microcítico - antineoplastic agents, protein kinase inhibitors - lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc) previously not treated with an alk inhibitor. lorviqua as monotherapy is indicated for the treatment of adult patients with alk‑positive advanced nsclc whose disease has progressed after:alectinib or ceritinib as the first alk tyrosine kinase inhibitor (tki) therapy; orcrizotinib and at least one other alk tki.

Unión Europea - español - EMA (European Medicines Agency)

pfizer europe ma eeig - glasdegib maleate - leucemia, mieloide, aguda - agentes antineoplásicos - daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (aml) in adult patients who are not candidates for standard induction chemotherapy.

Unión Europea - español - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - fibrosis quística - otros productos del sistema respiratorio - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Unión Europea - español - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - belantamab mafodotin - mieloma múltiple - agentes antineoplásicos - blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.