Európska únia - slovenčina - EMA (European Medicines Agency)

pfizer europe ma eeig - somatrogon - growth and development - hypofÝzy a hypotalamickÝch hormÓny a ich analÓgy - indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone.

Európska únia - slovenčina - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - prekurzorová bunková lymfoblastická leukémia-lymfóm - antineoplastické činidlá - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Európska únia - slovenčina - EMA (European Medicines Agency)

amgen europe b.v. - romiplostim - purpura, trombocytopenická, idiopatická - antihemoragiká - adults:nplate is indicated for the treatment of primary immune thrombocytopenia  (itp) in adult patients who are refractory to other treatments (e. kortikosteroidy, imunoglobulíny). paediatrics:nplate is indicated for the treatment of chronic primary immune thrombocytopenia (itp) in paediatric patients one year of age and older who are refractory to other treatments (e. kortikosteroidy, imunoglobulíny).

Európska únia - slovenčina - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinúria, paroxysmálna - selektívne imunosupresíva - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Európska únia - slovenčina - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate, metformin hydrochloride - diabetes mellitus, typ 2 - lieky používané pri cukrovke - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride sun is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. sitagliptin/metformin hydrochloride sun is indicated in combination with a sulphonylurea (i. trojlôžkových kombinovaná liečba) ako doplnok stravy a cvičenia pacientov nedostatočne kontrolované na ich maximálna tolerovaná dávka metformín a sulfonylmocoviny. sitagliptin/metformin hydrochloride sun is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparγ agonist. sitagliptin/metformin hydrochloride sun is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Európska únia - slovenčina - EMA (European Medicines Agency)

pfizer europe ma eeig  - abrocitinib - dermatitída, atopická - ostatné dermatologické prípravky - cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.

Európska únia - slovenčina - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - teriparatid - osteoporosis; osteoporosis, postmenopausal - homeostáza vápnika - teriparatide sun is indicated in adults. treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.

Európska únia - slovenčina - EMA (European Medicines Agency)

amgen europe b.v. - panitumumab - kolorektálne novotvary - antineoplastické činidlá - vectibix is indicated for the treatment of adult patients with wild-type ras metastatic colorectal cancer (mcrc): , in first-line in combination with folfox or folfiri. v druhej línii v kombinácii s folfiri pre pacientov, ktorí dostali v prvej línii fluoropyrimidine-založené chemoterapie (s výnimkou irinotecan). ako monotherapy po poruche fluoropyrimidine-, oxaliplatin-a irinotecan-obsahujúce chemoterapia režimy.

Európska únia - slovenčina - EMA (European Medicines Agency)

merck europe b.v. - avelumab - neuroendokrinné nádory - iné antineoplastické činidlá, monoklonálne protilátky, - bavencio je označené ako monotherapy na liečbu dospelých pacientov s metastatickým merkelová bunky karcinómu (mkc). bavencio v kombinácii s axitinib je uvedené, za prvé-line liečbu dospelých pacientov s pokročilým karcinómom obličiek (rcc). bavencio is indicated as monotherapy for the first‑line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc) who are progression-free following platinum‑based chemotherapy.

Európska únia - slovenčina - EMA (European Medicines Agency)

celgene europe bv - azacitidín - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastické činidlá - azacitidine celgene 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,aml with >30% marrow blasts according to the who classification.