Kroatien - kroatiska - HALMED (Agencija za lijekove i medicinske proizvode)

mylan ireland limited, unit 35/36 grange parade, baldoyle industrial estate, dublin 13, irska - sorafenibtosilat - filmom obložena tableta - 200 mg - urbroj: jedna filmom obložena tableta sadrži 200 mg sorafeniba (u obliku tosilata)

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

theravance biopharma ireland umited - telavancin - pneumonia, bacterial; cross infection - antibakterijski lijekovi za sistemsku primjenu, - vibativ je indiciran za liječenje odraslih s pneumonija uključujući ventilator povezane pneumonija, zna ili sumnja da uzrokuje meticilin-rezistentni staphylococcus aureus (mrsa). vibativ treba koristiti samo u slučajevima kada se zna ili pretpostavlja da su druge opcije ne odgovaraju. treba uzeti u obzir formalne preporuke za odgovarajuće korištenje antibakterijskih posrednika.

Kroatien - kroatiska - HALMED (Agencija za lijekove i medicinske proizvode)

bausch + lomb ireland limited, 3013 lake drive, citywest business campus, dublin 24, irska - dorzolamidklorid timololmaleat - kapi za oko, otopina - 20 mg/ml + 5 mg/ml - urbroj: jedan ml otopine sadrži 20 mg dorzolamida (u obliku dorzolamidklorida) i 5 mg timolola (u obliku timololmaleata)

Kroatien - kroatiska - HALMED (Agencija za lijekove i medicinske proizvode)

bausch + lomb ireland limited, 3013 lake drive, citywest business campus, dublin 24, irska - bimatoprost timololmaleat - kapi za oko, otopina - 0,3 mg/ml + 5 mg/ml - urbroj: jedan ml otopine sadrži 0,3 mg bimatoprosta i 5 mg timolola u obliku timololmaleata

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - dostarlimab - endometrial neoplasms - antineoplastic agents and antibody drug conjugates - jemparli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dmmr)/microsatellite instability-high (msi h) recurrent or advanced endometrial cancer (ec) that has progressed on or following prior treatment with a platinum-containing regimen.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

amarin pharmaceuticals ireland limited - icosapent ethyl - dislipidemije - sredstva za modifikaciju lipida - indicated to reduce cardiovascular risk as an adjunct to statin therapy.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

mylan ireland limited - abirateron acetat - prostatske neoplazme - 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.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

taw pharma (ireland) limited - klopidogrel hidroklorid - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - antitrombotska 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), 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. , , ,.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - velagluceraza alfa - gaucherova bolest - drugi gastrointestinalni trakt i metabolizam, lijekovi, - vpriv je indiciran za dugoročnu zamjensku enzimsku terapiju (ert) u bolesnika s tipom 1 gaucherove bolesti.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

eli lilly and company (ireland) limited - ixekizumab - psorijaza - imunosupresivi - peglanje psoriasistaltz propisan za liječenje srednje teške i teške forme бляшечного psorijaze kod odraslih, koji su kandidati za sistemske terapije. psorijatični arthritistaltz, sami ili u kombinaciji sa metotreksatom prikazana za liječenje aktivnog psorijatični artritis kod odraslih pacijenata, koji su neprimjereno reagirali, ili tko нетерпим na jedan ili više заболевани-дорабатывая anti-reumatskih lijekovi (dmards) terapija.