Den europeiske union - norsk - EMA (European Medicines Agency)

taw pharma (ireland) limited - klopidogrelhydroklorid - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - antithrombotic agents - , , , , 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. , , ,.

Den europeiske union - norsk - EMA (European Medicines Agency)

crealta pharmaceuticals ireland limited - pegloticase - gikt - antigout preparater - krystexxa er indisert for behandling av alvorlig ødeleggende kroniske tophaceous gikt hos voksne pasienter som har også erosive felles engasjement og som har mislyktes i å normalisere serum urinsyre med xantin oksidase hemmere nådd medisinsk passende dose eller som disse legemidlene er kontraindisert.

Den europeiske union - norsk - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - pegfilgrastim - nøytropeni - immunostimulants, - reduksjon i varigheten av nøytropeni og forekomsten av febril nøytropeni hos voksne pasienter behandlet med cytotoksiske kjemoterapi for kreft (med unntak av kronisk myelogen leukemi og aml syndromer).

Den europeiske union - norsk - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cystisk fibrose - andre åndedrettsprodukter - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 og 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 og 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

Den europeiske union - norsk - EMA (European Medicines Agency)

theravance biopharma ireland umited - telavancin - pneumonia, bacterial; cross infection - antibakterielle midler for systemisk bruk, - vibativ er indisert for behandling av voksne med nosocomial lungebetennelse inkludert ventilator-assosiert lungebetennelse, kjent eller mistenkt skyldes meticillinresistente staphylococcus aureus (mrsa). vibativ bør bare brukes i situasjoner der det er kjent eller mistanke om at andre alternativer er ikke egnet. det bør vurderes å offisielle retningslinjer for riktig bruk av antibakterielle midler.

Den europeiske union - norsk - EMA (European Medicines Agency)

mallinckrodt pharmaceuticals ireland limited - human fibrinogen, human trombin - hemostase, kirurgisk - antihemoragika - støttende behandling der standard kirurgiske teknikker er utilstrekkelige for forbedring av hemostase. raplixa må brukes i kombinasjon med en godkjent gelatin svamp. raplixa er indisert hos voksne over 18 år.

Norge - norsk - Statens legemiddelverk

topridge pharma (ireland) limited - isosorbidmononitrat - depottablett - 30 mg

Norge - norsk - Statens legemiddelverk

topridge pharma (ireland) limited - isosorbidmononitrat - depottablett - 60 mg

Den europeiske union - norsk - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - cystisk fibrose - andre åndedrettsprodukter - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t.

Den europeiske union - norsk - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - cannabidiol - lennox gastaut syndrome; epilepsies, myoclonic - antiepileptics, - epidyolex er indikert for bruk som adjuvant behandling av anfall assosiert med lennox gastaut syndrom (lgs) eller dravet syndrom (ds), i forbindelse med clobazam, for pasienter fra 2 år og eldre.