Evropská unie - čeština - EMA (European Medicines Agency)

amryt pharmaceuticals dac - dry extract from birch bark (der 5-10 : 1), extraction solvent n-heptane 95% (w/w) - epidermolysis bullosa dystrophica; epidermolysis bullosa, junctional - přípravky pro léčbu ran a vředů - treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (eb) in patients 6 months and older.

Česká republika - čeština - USKVBL (Ústav Pro Státní Kontrolu Veterinárních Biopreparátů A Léčiv)

boehringer ingelheim vetmedica, gmbh - penethamat hydroiodide, kombinace s jinými antibakteriálními - intramamární suspenze - beta-laktamová antibiotika, peniciliny, kombinace s jinými antibakteriálními - dojnice v období počátku stání na sucho

Česká republika - čeština - USKVBL (Ústav Pro Státní Kontrolu Veterinárních Biopreparátů A Léčiv)

univet, ltd. - rŮznÉ vÝrobky pro strukŮ a vemene - intramamární suspenze - produkty pro strukŮ a vemene - dojnice v období stání na sucho

Evropská unie - čeština - EMA (European Medicines Agency)

moderna biotech spain, s.l. - single-stranded, 5’-capped messenger rna (mrna) produced using a cell-free in vitro transcription from the corresponding dna templates, encoding the viral spike (s) protein of sars-cov-2 - covid-19 virus infection - vakcíny - spikevax is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older. spikevax bivalent original/omicron ba. 1 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against covid-19. spikevax bivalent original/omicron ba. 4-5 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older.  spikevax xbb. 5 is indicated for active immunisation to prevent covid 19 caused by sars-cov-2 in individuals 6 months of age and older. the use of this vaccine should be in accordance with official recommendations.

Česká republika - čeština - USKVBL (Ústav Pro Státní Kontrolu Veterinárních Biopreparátů A Léčiv)

bioveta, a.s. - cloxacillin - intramamární suspenze - beta-laktamázy rezistentní peniciliny - dojnice v období stání na sucho

Evropská unie - čeština - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cystická fibróza - jiné produkty dýchacích cest - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 a 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 a 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

Evropská unie - čeština - EMA (European Medicines Agency)

novartis europharm limited  - indacaterol, mometasone furoate - astma - léky na obstrukční onemocnění dýchacích cest, - bemrist breezhaler is indicated as a maintenance   treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.

Evropská unie - čeština - EMA (European Medicines Agency)

novartis europharm limited  - indacaterol acetate, mometasone furoate - astma - léky na obstrukční onemocnění dýchacích cest, - atectura breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.

Evropská unie - čeština - EMA (European Medicines Agency)

astrazeneca ab  - metformin-hydrochlorid, saxagliptin hydrochlorid - diabetes mellitus, typ 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - přípravek komboglyze je indikován jako přídatná léčba k dietě a cvičení ke zlepšení kontroly glykémie u dospělých pacientů ve věku 18 let a starších s diabetes mellitus typu 2 nedostatečně kontrolovaných maximální tolerovanou dávkou samotného metforminu, nebo ti, kteří již jsou léčených kombinací saxagliptin a metformin jako samostatné tablety. komboglyze je též indikován v kombinaci s inzulinem (já. trojkombinační léčbě) jako doplněk k dietním opatřením a cvičení s cílem zlepšit kontrolu glykémie u dospělých pacientů ve věku 18 let a starších s diabetem typu 2 diabetes mellitus, kdy inzulinu a metforminu samotného nezajistí dostatečnou kontrolu glykémie.

Evropská unie - čeština - EMA (European Medicines Agency)

astrazeneca ab - saxagliptin - diabetes mellitus, typ 2 - léky užívané při diabetu - add-on combination therapyonglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus 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 metformin alone, with diet and exercise, does not provide adequate glycaemic control;in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate;in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate;as triple oral therapy:in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control;as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.