Eiropas Savienība - slovāku - EMA (European Medicines Agency)

takeda manufacturing austria ag - octocog alfa - hemofília a - antihemoragiká - liečba a profylaxia krvácania u pacientov s hemofíliou a (vrodená deficiencia faktora viii). advate neobsahuje von willebrand faktor v farmakologicky účinných množstvách, a preto nie je uvedené v von willebrand ochorenia.

Eiropas Savienība - slovāku - 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.

Eiropas Savienība - slovāku - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - edoxaban tosilate - stroke; venous thromboembolism - antitrombotické činidlá - prevencia mozgovej príhody a systémovej embólie u dospelých pacientov s nevalvulárnou fibriláciou predsiení (nvaf) s jedným alebo viacerými rizikovými faktormi, ako je kongestívne srdcové zlyhanie, hypertenzia, vek ≥ 75 rokov, diabetes mellitus, predchádzajúca mozgová príhoda alebo prechodný ischemický záchvat ( tia). liečba hlbokej žilovej trombózy (dvt) a pľúcna embólia (pe), a prevencia opakujúcich sa dvt a pe u dospelých.

Eiropas Savienība - slovāku - EMA (European Medicines Agency)

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - antineoplastické činidlá - urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancer tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5. tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous nsclc who do not have egfr mutant or alk positive nsclc (see section 5. tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq ako monotherapy je indikovaný na liečbu dospelých pacientov s lokálne pokročilým alebo metastatickým nsclc po predchádzajúcej chemoterapie. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc) (see section 5. hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have not received prior systemic therapy (see section 5. urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancertecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq ako monotherapy je indikovaný na liečbu dospelých pacientov s lokálne pokročilým alebo metastatickým nsclc po predchádzajúcej chemoterapie. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. triple-negative breast cancertecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumours have pd-l1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

Eiropas Savienība - slovāku - EMA (European Medicines Agency)

csl behring gmbh - ľudský normálny imunoglobulín (scig) - syndrómy imunologickej nedostatočnosti - imunitný séra a imunoglobulíny, - replacement therapy in adults, children and adolescents (0-18 years) in:- primary immunodeficiency syndromes with impaired antibody production (see section 4. - secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of.

Eiropas Savienība - slovāku - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - nintedanib - idiopatická pľúcna fibróza - antineoplastické činidlá - ofev je indikovaný u dospelých na liečbu idiopatickej pľúcnej fibrózy (ipf).

Eiropas Savienība - slovāku - EMA (European Medicines Agency)

sfl pharmaceuticals deutschland gmbh - nyxthracis - anthrax - imunitný séra a imunoglobulíny, - obiltoxaximab sfl is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to bacillus anthracis (see section 5. obiltoxaximab sfl is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.

Eiropas Savienība - slovāku - EMA (European Medicines Agency)

dynavax gmbh - povrchový antigén hepatitídy b - Žltačka typu b - vakcíny - heplisav b is indicated for the active immunisation against hepatitis b virus infection (hbv) caused by all known subtypes of hepatitis b virus in adults 18 years of age and older. the use of heplisav b should be in accordance with official recommendations. it can be expected that hepatitis d will also be prevented by immunisation with heplisav b as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection.

Eiropas Savienība - slovāku - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - idarucizumab - krvácanie - všetky ostatné terapeutické produkty - praxbind je špecifické storno agent pre dabigatran a je indikovaný u dospelých pacientov liečených pradaxa (dabigatran etexilate), keď rýchly zvrat jeho anticoagulant účinky, je potrebné:pre núdzové operáciu/urgentné postupy;v život ohrozujúcich alebo nekontrolované krvácanie.

Eiropas Savienība - slovāku - EMA (European Medicines Agency)

csl behring gmbh - etranacogene dezaparvovec - hemofília b - other hematological agents - treatment of severe and moderately severe haemophilia b (congenital factor ix deficiency) in adult patients without a history of factor ix inhibitors.