Evropská unie - čeština - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - gastrointestinální stromální nádory - antineoplastická činidla - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (gist) who have received prior treatment with three or more kinase inhibitors, including imatinib.

Evropská unie - čeština - EMA (European Medicines Agency)

gilead sciences international ltd  - emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate - hiv infekce - antivirotika pro systémové použití - přípravek eviplera je indikován k léčbě dospělých pacientů infikovaných lidským virem imunodeficience typu 1 (hiv-1) bez známých mutací spojených s rezistencí na reverzní transkriptázy (nnrti) inhibitorů, tenofovir nebo emtricitabin, a s virové zatížení ≤ 100 000 hiv-1 rna kopií/ml. stejně jako u ostatních antiretrovirových léčivých přípravků by testy genotypové rezistence a / nebo historické údaje o rezistenci měly vést k užívání přípravku eviplera.

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

fresenius kabi s.r.o., praha array - 27 alanin; 96 arginin; 55 glycin; 717 histidin; 790 isoleucin; 829 leucin; 4566 lysin-acetÁt; 2445 methionin; 1117 fenylalanin; 4147 prolin; 4717 serin; 1418 taurin; 1459 threonin; 1503 tryptofan; 1507 tyrosin; 1514 valin; 5599 dihydrÁt chloridu vÁpenatÉho; 16396 natrium-glycerofosfÁt; 864 heptahydrÁt sÍranu hoŘeČnatÉho; 1174 chlorid draselnÝ; 1306 trihydrÁt natrium-acetÁtu; 4957 monohydrÁt glukosy - infuzní roztok - roztoky pro parenterÁlnÍ vÝŽivu, kombinace

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

fresenius kabi s.r.o., praha array - 4957 monohydrÁt glukosy; 27 alanin; 96 arginin; 55 glycin; 717 histidin; 790 isoleucin; 829 leucin; 4566 lysin-acetÁt; 2445 methionin; 1117 fenylalanin; 4147 prolin; 4717 serin; 1418 taurin; 1459 threonin; 1503 tryptofan; 1507 tyrosin; 1514 valin; 5599 dihydrÁt chloridu vÁpenatÉho; 18027 hydrÁt natrium-glycerofosfÁtu; 864 heptahydrÁt sÍranu hoŘeČnatÉho; 1174 chlorid draselnÝ; 1306 trihydrÁt natrium-acetÁtu; 1537 heptahydrÁt sÍranu zineČnatÉho; 1354 ČiŠtĚnÝ sÓjovÝ olej; 4090 triacylglyceroly se stŘednÍm ŘetĚzcem; 15999 ČiŠtĚnÝ olivovÝ olej; 17839 rybÍ olej bohatÝ na omega-3-kyseliny - infuzní emulze - roztoky pro parenterÁlnÍ vÝŽivu, kombinace

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

fresenius kabi ab, uppsala array - 4957 monohydrÁt glukosy; 1354 ČiŠtĚnÝ sÓjovÝ olej; 27 alanin; 96 arginin; 103 kyselina asparagovÁ; 665 kyselina glutamovÁ; 55 glycin; 717 histidin; 790 isoleucin; 829 leucin; 851 lysin-hydrochlorid; 2445 methionin; 1117 fenylalanin; 4147 prolin; 4717 serin; 1459 threonin; 1503 tryptofan; 1507 tyrosin; 1514 valin; 5599 dihydrÁt chloridu vÁpenatÉho; 16396 natrium-glycerofosfÁt; 864 heptahydrÁt sÍranu hoŘeČnatÉho; 1174 chlorid draselnÝ; 1306 trihydrÁt natrium-acetÁtu - infuzní emulze - roztoky pro parenterÁlnÍ vÝŽivu, kombinace

Česká republika - čeština - SUKL (Státní ústav pro kontrolu léčiv)

fresenius kabi s.r.o., praha array - 27 alanin; 96 arginin; 55 glycin; 717 histidin; 790 isoleucin; 829 leucin; 4566 lysin-acetÁt; 2445 methionin; 1117 fenylalanin; 4147 prolin; 4717 serin; 1418 taurin; 1459 threonin; 1503 tryptofan; 1507 tyrosin; 1514 valin; 5599 dihydrÁt chloridu vÁpenatÉho; 18027 hydrÁt natrium-glycerofosfÁtu; 864 heptahydrÁt sÍranu hoŘeČnatÉho; 1174 chlorid draselnÝ; 1306 trihydrÁt natrium-acetÁtu; 1537 heptahydrÁt sÍranu zineČnatÉho; 4957 monohydrÁt glukosy; 1354 ČiŠtĚnÝ sÓjovÝ olej; 4090 triacylglyceroly se stŘednÍm ŘetĚzcem; 15999 ČiŠtĚnÝ olivovÝ olej; 17839 rybÍ olej bohatÝ na omega-3-kyseliny - infuzní emulze - roztoky pro parenterÁlnÍ vÝŽivu, kombinace

Evropská unie - čeština - EMA (European Medicines Agency)

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.

Evropská unie - čeština - EMA (European Medicines Agency)

taw pharma (ireland) limited - hydrochlorid klopidogrelu - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - 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), ischaemic 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 segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy. , , 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. , , for further information please refer to section 5. , , ,.

Evropská unie - čeština - EMA (European Medicines Agency)

mylan ireland limited - rivaroxaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - antitrombotické činidla - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan 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.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention 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.

Evropská unie - čeština - EMA (European Medicines Agency)

kite pharma eu b.v. - autologous peripheral blood t cells cd4 and cd8 selected and cd3 and cd28 activated transduced with retroviral vector expressing anti-cd19 cd28/cd3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) - lymfom, mantle-cell - antineoplastická činidla - mantle cell lymphomatecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton’s tyrosine kinase (btk) inhibitor. acute lymphoblastic leukaemiatecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).