Europska Unija - hrvatski - EMA (European Medicines Agency)

viatris limited - klopidogrel besilat - peripheral vascular diseases; stroke; myocardial infarction - antitrombotska sredstva - 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). porastom segmenta st akutni infarkt miokarda, u kombinaciji s ask u liječenju pacijenata koji imaju pravo na thrombolytic terapije. 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. za više informacija, molimo pogledajte odjeljak 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

mylan pharmaceuticals limited - aripiprazola - schizophrenia; bipolar disorder - psycholeptics - aripiprazol mylan pharma je indiciran za liječenje shizofrenije kod odraslih i adolescenata starijih od 15 godina. Арипипразол Майлана pharma je indiciran za liječenje od umjerenih do teških maničnih epizoda kada je bipolarni poremećaj poremećaj i za prevenciju novog manic epizoda kod odraslih, koji su doživjeli pretežno manične epizode, a čiji je manične epizode odgovorio na арипипразол u liječenju. Арипипразол Майлана pharma je indiciran za liječenje do 12 tjedana umjerenih i teških maničnih epizoda u bipolarni poremećaj kod adolescenata u dobi od 13 godina i stariji.

Europska Unija - hrvatski - EMA (European Medicines Agency)

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

Europska Unija - hrvatski - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - lijekovi koji se koriste u dijabetesu - 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 i 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.

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

viatris limited, damastown industrial park, mulhuddart, dublin, irska - vankomicinklorid - prašak za otopinu za infuziju - urbroj: svaka bočica sadrži 1000 mg vankomicina (u obliku klorida), što odgovara 1 000 000 iu

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

viatris limited, damastown industrial park, mulhuddart, dublin, irska - vankomicinklorid - prašak za otopinu za infuziju - urbroj: svaka bočica sadrži 500 mg vankomicina (u obliku klorida), što odgovara 500 000 iu

Europska Unija - hrvatski - EMA (European Medicines Agency)

taw pharma (ireland) limited - klopidogrel hidroklorid - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - antitrombotska sredstva - , , , , 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. , , ,.

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

viatris hrvatska d.o.o., koranska 2, zagreb, hrvatska - azelastinklorid flutikazonpropionat - sprej za nos, suspenzija - 1 mg/g + 0,365 mg/g - urbroj: jedan gram suspenzije sadrži 1000 mikrograma azelastinklorida i 365 mikrograma flutikazonpropionata jednim potiskom (0,14 g) oslobađa se 137 mikrograma azelastinklorida (=125 mikrograma azelastina) i 50 mikrograma flutikazonpropionata

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

viatris hrvatska d.o.o., koranska 2, zagreb, hrvatska - adrenalin (epinefrin) - otopina za injekciju u napunjenoj brizgalici - 0,3 mg - urbroj: 1 ml sadrži 1 mg adrenalina (epinefrina). pojedinačna doza (0,3 ml) sadrži 0,3 mg (300 mikrograma) adrenalina

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

viatris hrvatska d.o.o., koranska 2, zagreb, hrvatska - adrenalin (epinefrin) - otopina za injekciju u napunjenoj brizgalici - 0,15 mg - urbroj: 1 ml sadrži 500 mikrograma adrenalina (epinefrina). pojedinačna doza (0,3 ml) sadrži 0,15 mg (150 mikrograma) adrenalina