Viatris Healthcare SA-NV - leitarniðurstöður

Evrópusambandið - íslenska - EMA (European Medicines Agency)

pirfenidone viatris

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

Evrópusambandið - íslenska - EMA (European Medicines Agency)

dapagliflozin viatris

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - lyf notuð við sykursýki - 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 og 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

clopidogrel viatris (previously clopidogrel taw pharma)

viatris limited - clopidogrel besilate - peripheral vascular diseases; stroke; myocardial infarction - blóðþurrðandi lyf - 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). l hækkun, bráð myndun stíflufleygs, ásamt asa í læknisfræðilega sjúklingum rétt fyrir segaleysandi meðferð. 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. nánari upplýsingar er að vísa til kafla 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

tobi podhaler

viatris healthcare limited - tóbramýcíni - cystic fibrosis; respiratory tract infections - sýklalyf fyrir almenn nota, - tobi podhaler er ætlað til bælingar á langvarandi lungnasýkingu vegna pseudomonas aeruginosa hjá fullorðnum og börnum 6 ára og eldri með blöðrubólgu. sjá kafla 4. 4 og 5. 1 varðandi gögn í mismunandi aldurshópum. Íhuga ætti að opinbera leiðsögn á réttri notkun af sýklalyfjum.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

tasmar

viatris healthcare limited - tolcapone - parkinsonsveiki - anti-parkinson lyf, Önnur dopaminergic lyfjum - tasmar er ætlað ásamt algengari / benserazide eða algengari / ddc hemli til að nota í sjúklinga með algengari-móttækilegur sjálfvakin parkinsonsveiki og mótor sveiflur, sem tókst ekki að svara eða þola af öðrum katekóllausn-o-methyltransferase (comt) hemlar. vegna hættu hugsanlega banvæn, bráð lifur meiðslum, tasmar ætti ekki að vera talin fyrsta lína viðbót meðferð til að algengari / benserazide eða algengari / ddc hemli. Þar tasmar skal aðeins notaður í ásamt algengari / benserazide og algengari / ddc hemli, ávísun fyrir þessum algengari undirbúningur er einnig við til þeirra samhliða nota með tasmar.