Europska Unija - hrvatski - EMA (European Medicines Agency)

gilead sciences ireland uc - ледипасвир, софосбувир - hepatitis c, kronični - antivirusni lijekovi za sustavnu uporabu - harvoni is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients aged 3 years and above (see sections 4. 2, 4. 4 i 5. virus hepatitisa c (hcv) genotip-specifične aktivnosti vidi 4. 4 i 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

sanofi winthrop industrie - klopidogrel - stroke; peripheral vascular diseases; atrial fibrillation; myocardial infarction; acute coronary syndrome - antitrombotska sredstva - sekundarne prevencije атеротромботических eventsclopidogrel prikazan:odrasli pacijenti koji pate инфарктом miokarda (od nekoliko dana do manje od 35 dana), ishemijski moždani udar (od 7 dana prije manje od 6 mjeseci) ili instaliranim bolest perifernih arterija. odraslih pacijenata oboljelih od akutne коронарным sindroma:bez elevacije segmenta st akutna koronarna sindrom (nestabilna angina, ili ne-q-инфарктом miokarda), uključujući i bolesnike koji su patili ugradnje stenta nakon чрескожного koronarne intervencije, u kombinaciji s ацетилсалициловой kiselinom (ask). st segment elevation acute myocardial infarction, in combination with asa in patients undergoing percutaneous coronary intervention (including patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. in patients with moderate to high-risk transient ischemic attack (tia) or minor ischemic 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. sprječavanje атеротромботических i тромбоэмболических događaja kada фибрилляции fibrillationin odraslih pacijenata s фибрилляцией vrlo značajan, koje imaju najmanje jedan faktor rizika za razvoj srčanih događaja, nisu pogodni za liječenje антагонистами vitamina k (ВКА) i koji imaju nizak rizik od krvarenja, клопидогрел prikazan u kombinaciji s ask za prevenciju атеротромботических i тромбоэмболических događaja, uključujući i moždani udar.

Europska Unija - hrvatski - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimikotika za sustavnu uporabu - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 i 5. 1):- invasive aspergillosisnoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4. 2 i 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 i 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 i 5. 1):- invasive aspergillosisnoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 i 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 i 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (gvhd) and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 i 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- haematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products;- oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

Europska Unija - hrvatski - EMA (European Medicines Agency)

sanofi winthrop industrie - klopidogrel hidrogensulfat - stroke; peripheral vascular diseases; atrial fibrillation; myocardial infarction; acute coronary syndrome - antitrombotska sredstva - secondary prevention of atherothrombotic eventsclopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six 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 patients undergoing percutaneous coronary intervention (including patients undergoing a stent replacement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. in patients with moderate to high-risk transient ischemic attack (tia) or minor ischemic 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. sprječavanje атеротромботических i тромбоэмболических događaja kada фибрилляции fibrillationin odraslih pacijenata s фибрилляцией vrlo značajan, koje imaju najmanje jedan faktor rizika za razvoj srčanih događaja, nisu pogodni za liječenje vitamin-k-antagonisti i koji imaju nizak rizik od krvarenja, клопидогрел prikazan u kombinaciji s ask za prevenciju атеротромботических i тромбоэмболических događaja, uključujući i moždani udar.

Europska Unija - hrvatski - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - Омбитасвир, паритапревир, ritonavir - hepatitis c, kronični - antivirusni lijekovi za sustavnu uporabu - viekirax je indiciran u kombinaciji s drugim lijekovima za liječenje kroničnog hepatitisa c (chc) u odraslih. virus hepatitisa c (hcv) genotip određene aktivnosti .

Europska Unija - hrvatski - EMA (European Medicines Agency)

krka, d.d., novo mesto - clopidogrel (as hydrogen sulfate) - peripheral vascular diseases; stroke; acute coronary syndrome; myocardial infarction - antitrombotska sredstva - prevencija sekundarne prevencije атеротромботических događaja klopidogrel prikazan:odrasli pacijenti koji pate инфарктом miokarda (od nekoliko dana do manje od 35 dana), ishemijski moždani udar (od 7 dana prije manje od 6 mjeseci) ili instaliranim bolest perifernih arterija. za odrasle pacijente koji pate od akutne коронарным sindroma:- bez elevacije segmenta st akutna koronarna sindrom (nestabilna angina, ili ne-q-инфарктом miokarda), uključujući i bolesnike koji su patili ugradnje stenta nakon чрескожного koronarne intervencije, u kombinaciji s ацетилсалициловой kiselinom (ask). - porast segmenta st akutni infarkt miokarda, u kombinaciji s ask u liječenju pacijenata koji imaju pravo na thrombolytic terapije. sprječavanje атеротромботических i тромбоэмболических događaja kada фибрилляции vrlo značajan:- kod odraslih bolesnika s фибрилляцией vrlo značajan, koje imaju najmanje jedan faktor rizika za razvoj srčanih događaja, nisu pogodni za liječenje антагонистами vitamina k (ВКА) i koji imaju nizak rizik od krvarenja, клопидогрел prikazan u kombinaciji s ask za prevenciju атеротромботических i тромбоэмболических događaja, uključujući i moždani udar.

Europska Unija - hrvatski - EMA (European Medicines Agency)

gilead sciences ireland uc - Софосбувир, velpatasvir, voxilaprevi - hepatitis c, kronični - antivirusni lijekovi za sustavnu uporabu - vosevi is indicated for the treatment of chronic hepatitis c virus (hcv) infection in patients aged 12 years and older and weighing at least 30 kg. (vidi 4. 2, 4. 4 i 5.

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb, hrvatska - klopidogrelhidrogensulfat - filmom obložena tableta - 75 mg - urbroj: jedna filmom obložena tableta sadrži 75 mg klopidogrela u obliku klopidogrelhidrogensulfata

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

merck d.o.o., oreškovićeva ulica 6h/1, zagreb, hrvatska - levotiroksinnatrij - tableta - 100 mikrograma - urbroj: jedna tableta sadrži 100 mikrograma levotiroksinnatrija

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

merck d.o.o., oreškovićeva ulica 6h/1, zagreb, hrvatska - levotiroksinnatrij - tableta - 112 mikrograma - urbroj: jedna tableta sadrži 112 mikrograma levotiroksinnatrija