Európai Unió - finn - EMA (European Medicines Agency)

taw pharma (ireland) limited - klopidogreelin hydrokloridi - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - antitromboottiset aineet - , , , , 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. , , ,.

Európai Unió - finn - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - antineoplastiset aineet - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

Európai Unió - finn - EMA (European Medicines Agency)

astrazeneca ab - fulvestrantti - rintojen kasvaimet - hormonaalisen hoidon, anti-estrogeenit - faslodex is indicated , as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:, , not previously treated with endocrine therapy, or, with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. , , , in combination with palbociclib for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. pre - tai huonomaineiset naiset, yhdistelmä-hoidon palbociclib olisi yhdistettävä luteinisoivan hormonin vapauttava hormoni (lhrh) - agonisteilla.

Európai Unió - finn - EMA (European Medicines Agency)

mylan ireland limited - rivaroksabaani - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - antitromboottiset aineet - 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.

Európai Unió - finn - EMA (European Medicines Agency)

schering-plough europe - interferoni alfa-2b - hepatitis c, chronic; hepatitis b, chronic - immunostimulantit, - krooninen hepatiitti b: n hoitoon aikuispotilailla, joilla on krooninen hepatiitti b, jotka liittyvät todisteet hepatiitti b-viruksen replikaatiota (hbv-dna-ja hbeag), kohonnut alaniiniaminotransferaasi (alt) ja histologisesti todistettu aktiivinen maksatulehdus ja/tai fibroosi. krooninen hepatiitti c aikuiset potilaat:introna on tarkoitettu aikuispotilaille, joilla on krooninen c-hepatiitti ja jotka ovat koholla, mutta maksan toiminta ei ole heikentynyt ja jotka ovat positiivinen hcv-rna-tai anti-hcv-infektio (ks. kohta 4. paras tapa käyttää introna tässä indikaatiossa on yhdessä ribaviriinin kanssa. lapset ja nuoret:introna on tarkoitettu käytettäväksi, kun yhdistelmähoitoa ribaviriinin kanssa, hoitoon lapsilla ja nuorilla 3 vuotta täyttäneille, joilla on krooninen hepatiitti c, ei ole aiemmin käsitelty, ilman maksan vajaatoimintaa, ja jotka ovat positiivisia seerumin hcv-rna. päätös hoitoon olisi tehtävä tapauskohtaisesti, ottaen huomioon mahdolliset todisteet taudin etenemistä, kuten maksan tulehdus ja fibroosi sekä prognostisia tekijöitä vastausta, hcv: n genotyyppi ja virusmäärä. odotettu hyöty hoito on punnittava turvallisuutta koskevat havainnot havaittu lapsipotilaalle kliinisissä tutkimuksissa (ks. kohdat 4. 4, 4. 8 ja 5.

Finnország - finn - Fimea (Suomen lääkevirasto)

gp-pharm s.a. gp-pharm s.a. - leuprorelini acetas - injektiokuiva-aine ja liuotin, depotsuspensiota varten - 22.5 mg - leuproreliini

Finnország - finn - Fimea (Suomen lääkevirasto)

gp-pharm s.a. gp-pharm s.a. - leuprorelini acetas - injektiokuiva-aine ja liuotin, depotsuspensiota varten - 3.75 mg - leuproreliini

Európai Unió - finn - EMA (European Medicines Agency)

tmc pharma (eu) limited - fosdenopterin hydrobromide dihydrate - metal metabolism, inborn errors - muut ruuansulatuselimistön sairauksien ja aineenvaihduntasairauksien lääkkeet, - nulibry is indicated for the treatment of patients with molybdenum cofactor deficiency (mocd) type a.

Finnország - finn - Fimea (Suomen lääkevirasto)

avansor pharma oy - rivaroxaban - tabletti, kalvopäällysteinen - 2.5 mg - rivaroksabaani

Európai Unió - finn - EMA (European Medicines Agency)

csl behring gmbh - ihmisen hyytymistekijä viii ihmisen von willebrand-tekijä - hemophilia a; von willebrand diseases - blood coagulation factors, von willebrand factor and coagulation factor viii in combination, antihemorrhagics - von willebrandin tauti (vwd)ennaltaehkäisyyn ja hoitoon verenvuoto tai kirurginen verenvuoto potilailla, joilla on vwd, kun desmopressiini (ddavp) hoito yksin on tehoton tai on vasta-aiheinen. hemofilia a (synnynnäinen tekijä viii puutos)ennaltaehkäisyyn ja hoitoon verenvuoto potilailla, joilla on hemofilia a.