यूरोपीय संघ - चेक - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - rekombinantní vezikulární stomatitis virus (kmen indiana) s odstranění obálky glykoprotein, nahrazuje zaire ebolavirus (kmen kikwit 1995) povrchový glykoprotein - hemoragická horečka, horečka ebola - vakcíny - ervebo is indicated for active immunization of individuals 1 year of age or older to protect against ebola virus disease (evd) caused by zaire ebola virus. použití ervebo by měla být v souladu s oficiálními doporučeními.

यूरोपीय संघ - चेक - EMA (European Medicines Agency)

dipharma arzneimittel gmbh - sapropterin-dihydrochloridu - fenylketonurie - jiné zažívací trakt a produkty metabolismu, - sapropterin dipharma is indicated for the treatment of hyperphenylalaninaemia (hpa) in adults and paediatric patients of all ages with phenylketonuria (pku) who have been shown to be responsive to such treatment. sapropterin dipharma is also indicated for the treatment of hyperphenylalaninaemia (hpa) in adults and paediatric patients of all ages with tetrahydrobiopterin (bh4) deficiency who have been shown to be responsive to such treatment.

यूरोपीय संघ - चेक - EMA (European Medicines Agency)

bayer ag - octocog alfa - hemofilie a - antihemoragika - léčba a profylaxe krvácení u pacientů s hemofilií a (vrozený nedostatek faktoru viii). iblias může být použit pro všechny věkové skupiny.

यूरोपीय संघ - चेक - EMA (European Medicines Agency)

orion corporation - dexmedetomidine hydrochloride - nervového systému, jiná hypnotika a sedativa - psi - zmírnění akutní úzkosti a strachu spojené s hlukem u psů.

यूरोपीय संघ - चेक - EMA (European Medicines Agency)

pfizer europe ma eeig - krizotinib - karcinom, plicní jiná než malobuněčná - antineoplastická činidla - xalkori as monotherapy is indicated for:the first‑line treatment of adults with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc)the treatment of adults with previously treated anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc)the treatment of adults with ros1‑positive advanced non‑small cell lung cancer (nsclc)the treatment of paediatric patients (age ≥6 to.

यूरोपीय संघ - चेक - EMA (European Medicines Agency)

bioprojet pharma - pitlisant - narkolepsie - další léky na nervový systém - wakix is indicated in adults, adolescents and children from the age of 6 years for the treatment of narcolepsy with or without cataplexy (see also section 5.

यूरोपीय संघ - चेक - EMA (European Medicines Agency)

bayer ag - rivaroxaban - arthroplasty, replacement; venous thromboembolism - antitrombotické činidla - přípravek xarelto, podávaný současně s kyselinou acetylsalicylovou (asa) samotnou nebo s asa plus klopidogrel nebo tiklopidin, je indikován k prevenci aterotrombotických příhod u dospělých pacientů po akutním koronárním syndromu (acs) se zvýšenou srdeční biomarkery. xarelto, co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. prevence žilní tromboembolie (vte) u dospělých pacientů, kteří podstoupili elektivní operaci náhrady kyčelního nebo kolenního kloubu. léčba hluboké žilní trombózy (dvt) a plicní embolie (pe) a prevence rekurentní dvt a pe u dospělých. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

यूरोपीय संघ - चेक - EMA (European Medicines Agency)

pfizer europe ma eeig - tofacitinib - artritida, revmatoidní - imunosupresiva - rheumatoid arthritistofacitinib in combination with methotrexate (mtx) is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (dmards) (see section 5. tofacitinib can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate (see sections 4. 4 a 4. psoriatic arthritistofacitinib in combination with mtx is indicated for the treatment of active psoriatic arthritis (psa) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (dmard) therapy (see section 5. ulcerative colitistofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5. tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [rf+] or negative [rf-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (psa) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (dmards). tofacitinib can be given in combination with methotrexate (mtx) or as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. ankylosing spondylitistofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have responded inadequately to conventional therapy.

यूरोपीय संघ - चेक - EMA (European Medicines Agency)

akcea therapeutics ireland limited - volanesorsen sodíku - hyperlipoproteinémie typu i - další lipidové modifikace agenti - waylivra je indikován jako doplněk diety u dospělých pacientů s geneticky potvrzenou dědičnou chylomicronemia syndrom (fcs) a na vysoké riziko pankreatitidy, u kterých odpověď na dietu a snižování hladiny triglyceridů terapie byla nedostatečná.

यूरोपीय संघ - चेक - EMA (European Medicines Agency)

nabriva therapeutics ireland dac - lefamulin acetate - pneumonia, bacterial; community-acquired infections - antibakteriální látky pro systémové použití, - xenleta is indicated for the treatment of community-acquired pneumonia (cap) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of cap or when these have failed. pozornost by měla být věnována oficiálním doporučením pro správné používání antibakteriálních látek.