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

mylan ireland limited - rivaroksaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - antithrombotic agents - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

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)

mylan ireland limited - abirateronacetat - prostata neoplasmer - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

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

mylan pharmaceuticals limited - prasugrel besilate - myocardial infarction; acute coronary syndrome; angina, unstable - antithrombotic agents - prasugrel mylan, co gis med acetylsalisylsyre (asa), er indikert for forebygging av atherothrombotic hendelser hos voksne pasienter med akutt koronar syndrom (i. ustabil angina, ikke-st-segmentet elevation myocardial infarction [ua/nstemi] eller st-segmentet elevation myocardial infarction [stemi]) gjennomgår primære eller forsinket perkutan koronar intervensjon (pci).

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

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

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

abbvie deutschland gmbh & co. kg - linaclotide - irritabel tarm-syndrom - narkotika for forstoppelse - constella er indisert for symptomatisk behandling av moderat til alvorlig irritabel tarmsyndrom med forstoppelse (ibs-c) hos voksne.

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

mylan pharmaceuticals limited - fulvestrant - bryst neoplasms - endokrin terapi - fulvestrant er angitt for behandling av østrogen reseptor positiv, lokalt avansert eller metastatisk brystkreft hos postmenopausale kvinner:ikke tidligere er behandlet med endokrin terapi, orwith sykdom tilbakefall på eller etter adjuvant anti-østrogen behandling, eller progresjon av sykdommen på antiestrogen terapi.

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

belpharma s.a. - tasonermin - sarkom - immunostimulants, - beromun er indisert hos voksne som et supplement til kirurgi for senere fjerning av svulsten, slik som å hindre eller forsinke amputasjon, eller i palliativ situasjon, for irresectable av mykt vev sarkom av lemmer, som brukes i kombinasjon med melphalan via mild hyperthermic isolert-lem perfusjon (ilp).

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

omrix biopharmaceuticals n. v. - human fibrinogen, human trombin - hemostase - lokale hemostatics - støttende behandling i voksenoperasjon der standard kirurgiske teknikker er utilstrekkelige (se avsnitt 5. 1):- for forbedring av haemostasis.

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

navidea biopharmaceuticals europe ltd. - tilmanocept - radionuklide bildebehandling - svulsten deteksjon, diagnose radiopharmaceuticals - dette legemidlet er kun til diagnostisk bruk. radiolabelled lymphoseek er indikert for bildebehandling og intraoperative påvisning av sentinel lymfeknuter drenering en primær tumor hos voksne pasienter med brystkreft, melanom, eller lokalisert plateepitelkarsinom i munnhulen. eksterne bildebehandling og intraoperative evaluering kan utføres ved bruk av gamma-gjenkjenning enheten.