Clopidogrel Viatris (previously Clopidogrel Taw Pharma) Evropská unie - čeština - EMA (European Medicines Agency)

clopidogrel viatris (previously clopidogrel taw pharma)

viatris limited - klopidogrel besilate - peripheral vascular diseases; stroke; myocardial infarction - antitrombotické činidla - secondary prevention of atherothrombotic events clopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. adult patients suffering from acute coronary syndrome. non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa). st elevace akutního infarktu myokardu, v kombinaci s asa u medikamentózně léčených pacientů vhodných pro trombolytickou terapii. in patients with moderate to high-risk transient ischaemic attack (tia) or minor ischaemic stroke (is) clopidogrel in combination with asa is indicated in:adult patients with moderate to high-risk tia (abcd2 score ≥4) or minor is (nihss ≤3) within 24 hours of either the tia or is event. prevention of atherothrombotic and thromboembolic events in atrial fibrillation:in adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke. pro další informace viz bod 5.

Pirfenidone Viatris Evropská unie - čeština - EMA (European Medicines Agency)

pirfenidone viatris

viatris limited - pirfenidon - idiopathic pulmonary fibrosis; lung diseases; respiratory tract diseases - imunosupresiva - pirfenidone viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

Dapagliflozin Viatris Evropská unie - čeština - EMA (European Medicines Agency)

dapagliflozin viatris

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - léky užívané při diabetu - type 2 diabetes mellitusdapagliflozin viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 a 5. heart failuredapagliflozin viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. chronic kidney diseasedapagliflozin viatris is indicated in adults for the treatment of chronic kidney disease.

Ultomiris Evropská unie - čeština - EMA (European Medicines Agency)

ultomiris

alexion europe sas - ravulizumab - hemoglobinurie, paroxysmální - selektivní imunosupresiva - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Xigris Evropská unie - čeština - EMA (European Medicines Agency)

xigris

eli lilly nederland b.v. - drotrekogin alfa (aktivovaný) - sepsis; multiple organ failure - antitrombotické činidla - přípravek xigris je indikován k léčbě dospělých pacientů s těžkou sepsí s selháním více orgánů při přidání do nejlepší standardní péče. použití přípravku xigris by mělo být zvažováno zejména v situacích, kdy může být léčba zahájena do 24 hodin po nástupu selhání orgánu (další informace viz část 5.

Soliris Evropská unie - čeština - EMA (European Medicines Agency)

soliris

alexion europe sas - ekulizumab - hemoglobinurie, paroxysmální - imunosupresiva - přípravek soliris je indikován u dospělých a dětí k léčbě:paroxysmální noční hemoglobinurie (pnh). důkazy o klinické prospěšnosti je prokázána u pacientů s hemolýza s klinickým příznakem(s) svědčí o vysoké aktivity nemoci, bez ohledu na to, transfúze historie (viz bod 5. atypický hemolyticko-uremický syndrom (ahus). přípravek soliris je indikován u dospělých k léčbě:Žáruvzdorné generalizované myasthenia gravis (gmg) u pacientů, kteří jsou anti-acetylcholinové receptory (achr) protilátky-pozitivní (viz bod 5. neuromyelitis optica spectrum disorder (nmosd) u pacientů, kteří jsou anti-aquaporin-4 (aqp4) protilátky-pozitivní s recidivující průběh onemocnění.

IRIS VERSICOLOR 2CH-200CH Granule Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

iris versicolor 2ch-200ch granule

boiron, messimy array - 50114 iris versicolor - dilutio homeopathica - granule - 2ch-200ch - homeopatika (ČeskÁ atc skupina)

TAMSULOSIN +PHARMA 0,4MG Tableta s prodlouženým uvolňováním Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

tamsulosin +pharma 0,4mg tableta s prodlouženým uvolňováním

+pharma arzneimittel gmbh, graz array - 14672 tamsulosin-hydrochlorid - tableta s prodlouženým uvolňováním - 0,4mg - tamsulosin

DULOXETIN +PHARMA 30MG Enterosolventní tvrdá tobolka Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

duloxetin +pharma 30mg enterosolventní tvrdá tobolka

+pharma arzneimittel gmbh, graz array - 17225 duloxetin-hydrochlorid - enterosolventní tvrdá tobolka - 30mg - duloxetin

DULOXETIN +PHARMA 60MG Enterosolventní tvrdá tobolka Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

duloxetin +pharma 60mg enterosolventní tvrdá tobolka

+pharma arzneimittel gmbh, graz array - 17225 duloxetin-hydrochlorid - enterosolventní tvrdá tobolka - 60mg - duloxetin