Европска Унија - Словачки - EMA (European Medicines Agency)

mylan ire healthcare limited - pretomanid - tuberkulóza, odolná voči viacerým liečivám - antimycobacterials - dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (xdr), or treatment-intolerant or nonresponsive multidrug-resistant (mdr) tuberculosis (tb). je treba vziať do úvahy oficiálne usmernenie o vhodnom používaní antibakteriálne agentov.

Европска Унија - Словачки - EMA (European Medicines Agency)

novo nordisk a/s - semaglutide - obesity; overweight - prípravky proti obezite, okrem diétne výrobky - wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial body mass index (bmi) of- ≥30 kg/m² (obesity), or- ≥27 kg/m² to.

Европска Унија - Словачки - EMA (European Medicines Agency)

merck europe b.v. - tepotinib hydrochloride monohydrate - karcinóm, pľúc bez malých buniek - antineoplastické činidlá - tepmetko 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.

Европска Унија - Словачки - EMA (European Medicines Agency)

eli lilly nederland b.v. - tirzepatide - diabetes mellitus, typ 2 - lieky používané pri cukrovke - mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications- in addition to other medicinal products for the treatment of diabetes. for study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4. 4, 4. 5 a 5.

Европска Унија - Словачки - EMA (European Medicines Agency)

amryt pharmaceuticals dac - octreotide acetate - akromegália - hypofýzové a hypotalamické hormóny a analógy - mycapssa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.

Европска Унија - Словачки - 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.

Европска Унија - Словачки - EMA (European Medicines Agency)

recordati rare diseases - zinok - hepatolentikulárna degenerácia - iné alimentárny trakt a metabolizmus výrobky, - liečba wilsonovej choroby.

Европска Унија - Словачки - EMA (European Medicines Agency)

novartis europharm limited - ceritinib - karcinóm, pľúc bez malých buniek - antineoplastické činidlá - zykadia je indikovaná na liečbu dospelých pacientov s anamnézou pokročilého nemalobunkového karcinómu pľúc (nsclc) s anaplastickou lymfóm kinázou (alk), ktorá bola predtým liecená krizotinibom.

Европска Унија - Словачки - EMA (European Medicines Agency)

medac gesellschaft fuer klinische spezialpraeparate mbh - asparagináza - prekurzorová bunková lymfoblastická leukémia-lymfóm - antineoplastické činidlá - spectrila je indikovaná ako súčasť protinádorovej kombinovanej liečby na liečbu akútna lymfoblastická leukémia (all) u pediatrických pacientov od narodenia do 18 rokov a dospelých.

Европска Унија - Словачки - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - linagliptin - diabetes mellitus, typ 2 - lieky používané pri cukrovke - trajenta je indikovaný v liečbe diabetes mellitus 2. typu na zlepšenie glykemický kontroly u dospelých:ako monotherapyin pacientov nedostatočne kontrolovaná diétou a cvičením samostatne, a pre ktorých je metformín je nevhodné z dôvodu neznášanlivosti, alebo kontraindikovaný v dôsledku obličiek. ako zmes therapyin kombinácii s metformínom, keď diéta a cvičenie plus metformín sám neposkytujú dostatočnú glykemický ovládanie. v kombinácii s sulfonylmocoviny a metformín, keď diéta a cvičenie plus dual terapia pomocou týchto liekov neposkytujú dostatočnú glykemický ovládanie. v kombinácii s inzulínom s metformínom alebo bez, keď sa tento režim sám, s diétou a cvičením, neposkytuje adekvátnu glykemický ovládanie.