Evropska unija - slovenščina - 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).

Evropska unija - slovenščina - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - zdravila, ki se uporabljajo pri diabetesu - 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 in 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

viatris limited - klopidogrel besilat - peripheral vascular diseases; stroke; myocardial infarction - antitrombotična 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). st segmentu višinskih akutni miokardni infarkt, v kombinaciji s asa v medicinsko zdravljenih bolnikih, ki izpolnjujejo pogoje za thrombolytic terapija. 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 nadaljnje informacije, prosimo, preberite razdelek 5.

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

mylan healthcare d.o.o. - sotalol - tableta - sotalol 70,54 mg / 1 tableta - sotalol

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

mylan ireland limited - atorvastatin - filmsko obložena tableta - atorvastatin 20 mg / 1 tableta - atorvastatin

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

mylan ireland limited - atorvastatin - filmsko obložena tableta - atorvastatin 40 mg / 1 tableta - atorvastatin

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan ire healthcare limited - fondaparinuks natrij - venous thrombosis; pulmonary embolism; myocardial infarction; angina, unstable - antitrombotična sredstva - 5 mg / 0. 3 ml in 2. 5 mg / 0. 5-ml solution for injectionprevention of venous thromboembolic events (vte) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery. preprečevanje vte pri odraslih, ki opravljajo abdominalno kirurgijo, ki so presodilo, da je velika verjetnost, thromboembolic zapletov, kot bolnikov, ki abdominalno operacijo raka. preprečevanje vte pri odraslih bolnike, ki so presodilo, da je na visoko tveganje za vte in ki so immobilised zaradi akutne bolezni, kot so srčno insuficienco in / ali akutne dihalne motnje in / ali akutne nalezljive ali vnetnih bolezni. zdravljenje odraslih z akutno simptomatsko spontano površno-venska tromboza spodnjih okončin brez sočasnega globoko vensko trombozo. 5 mg / 0. 5-ml solution for injectiontreatment of unstable angina or non-st-segment-elevation myocardial infarction (ua/nstemi) in adult patients for whom urgent (< 120 mins) invasive management (pci) is not indicated. infarkt (stemi) pri odraslih bolnikih, ki se upravljajo z thrombolytics ali ki sprva so prejeli nobena druga oblika reperfusion terapija. 5 mg / 0. 4-ml, 7. 5 mg / 0. 6-ml in 10 mg/0. 8-ml solution for injectiontreatment of adults with acute deep-vein thrombosis (dvt) and treatment of acute pulmonary embolism (pe), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.

Evropska unija - slovenščina - EMA (European Medicines Agency)

viatris limited - sildenafil citrat - hipertenzija, pljučnica - urološki - adultstreatment odraslih bolnikih s pljučne arterijske hipertenzije, ki so razvrščene kot funkcijski razred ii in iii, za izboljšanje vadbe zmogljivosti. učinkovitost je bila dokazana pri primarni pljučni hipertenziji in pljučni hipertenziji, povezani z boleznijo vezivnega tkiva. pediatrični populationtreatment pri pediatričnih bolnikih, starih od 1 leta do 17 let, s pljučne arterijske hipertenzije. učinkovitost v smislu izboljšanja telesne zmogljivosti ali pljučne hemodinamike je bila prikazana v primarni pljučni hipertenziji in pljučni hipertenziji, povezani s prirojeno srčno boleznijo (glejte poglavje 5.

Evropska unija - slovenščina - EMA (European Medicines Agency)

viatris limited - tadalafil - hipertenzija, pljučnica - urološki - talmanco je indicirano pri odraslih za zdravljenje pljučne arterijske hipertenzije (pah) uvrščene, ki funkcionalno razreda ii in iii, izboljšati uresničevanje sposobnosti. učinkovitost so pokazali pri idiopatskem pah (ipah) in pri pah, povezani s kolagensko vaskularno boleznijo.

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

bortezomib - prašek za raztopino za injiciranje - bortezomib 3,5 mg / 1 viala - bortezomib