Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

theramex ireland limited, 3rd floor, kilmore house, park lane, spencer dock, dublin, irska - ganireliksacetat - otopina za injekciju u napunjenoj štrcaljki - urbroj: jedna napunjena štrcaljka sadrži 0,25 mg ganireliksa (u obliku ganireliksacetata) u 0,5 ml vodene otopine

Europska Unija - hrvatski - EMA (European Medicines Agency)

theramex ireland limited - abaloparatide - osteoporosis, postmenopausal; osteoporosis - homeostaza kalcija - liječenje osteoporoze kod žena u postmenopauzi s povećanim rizikom od prijeloma.

Europska Unija - hrvatski - EMA (European Medicines Agency)

theramex ireland limited - follitropin alfa - anovulacija - spolni hormoni i modulatori genitalnog sustava, - kod odraslih womenanovulation (uključujući sindrom policističnih jajnika), kod žena, koji su bili otporni na liječenje klomifen цитратом;poticanje razvoja brojnih folikula kod žena, patili суперовуляции za pomoćne reproduktivnih tehnologija (ВРТ), kao i in vitro fertilizacije (ivf), гаметы unutar-маточную prijenos i zygote unutar-маточную prijenosa;ovaleap u vezi s лютенизирующий hormon (lh) je lijek preporuča se primijeniti za poticanje razvoja folikula kod žena s velikim deficitom lh i fsh. u kliničkim istraživanjima kod ovih pacijenata su identificirani endogene razina lh u serumu < 1. 2 iu/l. u odrasloj menovaleap indiciran za stimulaciju сперматогенеза muškaraca, koji su urođene ili stečene гипогонадотропный гипогонадизм s popratnim humani korionski gonadotropin (hcg) terapija.

Europska Unija - hrvatski - EMA (European Medicines Agency)

theramex ireland limited - teriparatid - osteoporoza - homeostaza kalcija - livogiva is indicated in adults. liječenje osteoporoze u žena u postmenopauzi i muškaraca pri povećanom riziku od loma. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. liječenje osteoporoze, povezan sa stalnim sistemsku terapiju s glukokortikoidi, kod žena i muškaraca pod povećanim rizikom prijeloma.

Europska Unija - hrvatski - EMA (European Medicines Agency)

theramex ireland limited - linzagolix choline - uterusa - hipofiza i hipotalamusni hormoni i analozi - yselty is indicated for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

Europska Unija - hrvatski - EMA (European Medicines Agency)

theramex ireland limited - nomegestrol acetat, estradiol - kontracepcija - spolni hormoni i modulatori genitalnog sustava, - oral contraception,.

Europska Unija - hrvatski - EMA (European Medicines Agency)

endoceutics s.a. - pripravak прастерона - postmenopauzi - ostali spolni hormoni i modulatori genitalnog sustava - intrarosa je indicirana za liječenje vulve i vaginalne atrofije u žena u postmenopauzi koje imaju umjerene do teške simptome.

Europska Unija - hrvatski - 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.

Europska Unija - hrvatski - 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. , , ,.

Europska Unija - hrvatski - EMA (European Medicines Agency)

crealta pharmaceuticals ireland limited - pegloticase - giht - antigadni pripravci - krystexxa je indiciran za liječenje teškog oslabiti kronične tophaceous gihta u odraslih bolesnika koji može imati erozivni zajednički angažman i koji nisu uspjeli normalizirati serumske mokraćne kiseline s ksantin oksidaza inhibitori maksimalno medicinski odgovarajuće doze ili kojima ovi lijekovi su kontraindicirani.