Oxbryta Unión Europea - español - EMA (European Medicines Agency)

oxbryta

pfizer europe ma eeig  - voxelotor - anemia; anemia, hemolytic; anemia, sickle cell - other hematological agents - oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (scd) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.

Ontilyv Unión Europea - español - EMA (European Medicines Agency)

ontilyv

bial portela & companhia s.a. - opicapone - mal de parkinson - medicamentos contra el parkinson - ontilyv is indicated as adjunctive therapy to preparations of levodopa/ dopa decarboxylase inhibitors (ddci) in adult patients with parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

Breyanzi Unión Europea - español - EMA (European Medicines Agency)

breyanzi

bristol-myers squibb pharma eeig - cd19-directed genetically modified autologous cell-based product consisting of purified cd8+ t-cells (cd8+ cells), cd19-directed genetically modified autologous cell-based product consisting of purified cd4+ t cells (cd4+ cells) - lymphoma, large b-cell, diffuse; lymphoma, follicular; mediastinal neoplasms - agentes antineoplásicos - breyanzi is indicated for the treatment of adult patients with diffuse large b-cell lymphoma (dlbcl), high grade b-cell lymphoma (hgbcl), primary mediastinal large b-cell lymphoma (pmbcl) and follicular lymphoma grade 3b (fl3b), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

Uplizna Unión Europea - español - EMA (European Medicines Agency)

uplizna

horizon therapeutics ireland dac - inebilizumab - neuromyelitis optica - inmunosupresores - uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (nmosd) who are anti-aquaporin 4 immunoglobulin g (aqp4-igg) seropositive (see section 5.

Zokinvy Unión Europea - español - EMA (European Medicines Agency)

zokinvy

eigerbio europe limited - lonafarnib - progeria; laminopathies - otros tracto alimentario y metabolismo de los productos, - zokinvy is indicated for the treatment of patients 12 months of age and older with a genetically confirmed diagnosis of hutchinson-gilford progeria syndrome or a processing-deficient progeroid laminopathy associated with either a heterozygous lmna mutation with progerin-like protein accumulation or a homozygous or compound heterozygous zmpste24 mutation.

Sitagliptin Accord Unión Europea - español - EMA (European Medicines Agency)

sitagliptin accord

accord healthcare s.l.u. - sitagliptin hydrochloride - diabetes mellitus, tipo 2 - drogas usadas en diabetes - for adult patients with type 2 diabetes mellitus, sitagliptin accord is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (ppary) agonist (i. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Vildagliptin / Metformin hydrochloride Accord Unión Europea - español - EMA (European Medicines Agency)

vildagliptin / metformin hydrochloride accord

accord healthcare s.l.u. - metformin hydrochloride, vildagliptin - diabetes mellitus, tipo 2 - drogas usadas en diabetes - vildagliptin/metformin hydrochloride accord 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 glycaemic control (see sections 4. 4, 4. 5 y 5. 1 para datos disponibles sobre diferentes combinaciones).

Nulibry Unión Europea - español - EMA (European Medicines Agency)

nulibry

tmc pharma (eu) limited - fosdenopterin hydrobromide dihydrate - metal metabolism, inborn errors - otros tracto alimentario y metabolismo de los productos, - nulibry is indicated for the treatment of patients with molybdenum cofactor deficiency (mocd) type a.

Tabrecta Unión Europea - español - EMA (European Medicines Agency)

tabrecta

novartis europharm limited  - capmatinib dihydrochloride monohydrate - carcinoma, pulmón no microcítico - agentes antineoplásicos - tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.