Evropská unie - čeština - EMA (European Medicines Agency)

pfizer limited - celekoxib - adenomatózní polypóza coli - antineoplastická činidla - onsenal je indikován pro snížení počtu adenomatózní polypy střevní v familiární adenomatózní polypózy (fap), jako doplněk chirurgie a dále endoskopické sledování (viz bod 4. Účinek přípravku onsenal-snížení zátěže polypy vyvolaný na riziko střevního karcinomu nebyl prokázán (viz body 4. 4 a 5.

Evropská unie - čeština - EMA (European Medicines Agency)

novartis europharm limited - dabrafenib mesilate - melanom - antineoplastická činidla - melanomadabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 a 5. adjuvantní léčba melanomadabrafenib v kombinaci s trametinib je indikován k adjuvantní léčbě dospělých pacientů s stadiu iii melanomu s braf v600 mutaci, po kompletní resekci. non-small cell lung cancer (nsclc)dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.

Evropská unie - čeština - EMA (European Medicines Agency)

merck sharp & dohme b.v. - ertugliflozin l-pyroglutamic acid, metformin hydrochloride - diabetes mellitus, typ 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - segluromet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:in patients not adequately controlled on their maximally tolerated dose of metformin alonein patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetesin patients already being treated with the combination of ertugliflozin and metformin as separate tablets.

Evropská unie - čeština - EMA (European Medicines Agency)

scipharm sàrl - treprostinil sodný - hypertenze, plicní - antitrombotické činidla - treatment of adult patients with who functional class (fc) iii or iv and:inoperable chronic thromboembolic pulmonary hypertension (cteph), orpersistent or recurrent cteph after surgical treatmentto improve exercise capacity.

Evropská unie - čeština - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - gastrointestinální stromální nádory - jiná cytostatika, inhibitory proteinkinázy - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

Evropská unie - čeština - EMA (European Medicines Agency)

aimmune therapeutics ireland limited - defatted powder of arachis hypogaea l., semen (peanuts) - peanut hypersensitivity - allergens - palforzia is indicated for the treatment of patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy. palforzia may be continued in patients 18 years of age and older. palforzia should be used in conjunction with a peanut-avoidant diet.

Evropská unie - čeština - EMA (European Medicines Agency)

secura bio limited - duvelisib - leukemia, lymphocytic, chronic, b-cell; lymphoma, follicular - antineoplastická činidla - copiktra monotherapy is indicated for the treatment of adult patients with: relapsed or refractory chronic lymphocytic leukaemia (cll) after at least two prior therapies.  follicular lymphoma (fl) that is refractory to at least two prior  systemic therapies.

Evropská unie - čeština - EMA (European Medicines Agency)

biogen netherlands b.v. - diroximel fumarate (biib098) - roztroušená skleróza, relaps-remitentní - imunosupresiva - vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5. 1 for important information on the populations for which efficacy has been established).

Evropská unie - čeština - EMA (European Medicines Agency)

bioprojet pharma - pitlisant - sleep apnea, obstructive - další léky na nervový systém - ozawade is indicated to improve wakefulness and reduce excessive daytime sleepiness (eds) in adult patients with obstructive sleep apnoea (osa).

Evropská unie - čeština - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - pneumococcal polysaccharide conjugate vaccine (adsorbed) - pneumokokové infekce - pneumococcus, purified polysaccharides antigen conjugated - vaxneuvance is indicated for active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age. vaxneuvance is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by streptococcus pneumoniae in individuals 18 years of age and older. viz kapitoly 4. 4 a 5. 1 pro informace o ochraně proti specifickým pneumokokovým sérotypům. the use of vaxneuvance should be in accordance with official recommendations.