Europeiska unionen - kroatiska - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - odbacivanje transplantata - imunosupresivi - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Europeiska unionen - kroatiska - 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.

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - cistična fibroza - drugi proizvodi respiratornog sustava - 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.

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

mylan ireland limited, unit 35/36 grange parade, baldoyle industrial estate, dublin 13, irska - abakavirsulfat lamivudin - filmom obložena tableta - 600 mg + 300 mg - urbroj: jedna filmom obložena tableta sadrži 600 mg abakavira (u obliku abakavirsulfata) i 300 mg lamivudina

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

mcneil healthcare (ireland) limited, tallaght, high street, office 5, 6 & 7, block 5, dublin, irska - loperamidklorid - raspadljiva tableta za usta - 2 mg - urbroj: jedna raspadljiva tableta za usta sadrži 2 mg loperamidklorida

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

mcneil healthcare (ireland) limited, tallaght, high street, office 5, 6 & 7, block 5, dublin, irska - loperamidklorid simetikon - tableta - 2 mg + 125 mg - urbroj: jedna tableta sadrži 2 mg loperamidklorida i 125 mg dimetikona kao simetikon

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

centus biotherapeutics europe limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell - antineoplastična sredstva - bevacizumab u kombinaciji s kemoterapijom na bazi fluoropirimidina je indiciran za liječenje odraslih bolesnika s metastatskim karcinomom debelog crijeva ili rektuma. Бевацизумаб u kombinaciji s паклитакселом dizajniran za prvu liniju tretmana odraslih pacijenata s metastaze raka dojke . za daljnje informacije o stanju čovjeka epidermalnog faktora rasta receptora 2 (her2), molimo pogledajte odjeljak 5. Бевацизумаб u kombinaciji s капецитабином dizajniran za prvu liniju terapije bolesnika s metastaze raka dojke kod kojih je liječenje s drugim opcijama kemoterapije, uključujući таксаны ili антрациклины, smatra se neprikladnim. patients who have received taxane and anthracycline- containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with equidacent in combination with capecitabine. dodatne informacije o statusu her2 potražite u odjeljku 5. bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Бевацизумаб u kombinaciji s эрлотинибом, prikazan je za prva linija terapije kod odraslih pacijenata s нерезектабельными-najčešće metastaze ili recidivom неороговевающий немелкоклеточного raka pluća s epidermalnog faktora rasta (egfr) aktiviraju mutacije. bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor-targeted agents. Бевацизумаб u kombinaciji s паклитакселом i цисплатином ili паклитакселом i топотеканом kod pacijenata koji ne mogu dobiti платиновую terapiju, indiciran za liječenje odraslih bolesnika s uporni, relaps ili метастатической карциномой grlića maternice.

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

besins healthcare ireland limited, 16 pembroke street upper, dublin 2, irska - progesteron - kapsula za rodnicu, meka - urbroj: jedna kapsula sadrži 300 mg progesterona (mikroniziranog)

Europeiska unionen - kroatiska - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - flutikazon furoat - rhinitis, allergic, seasonal; rhinitis, allergic, perennial - nosni lijekovi, kortikosteroidi, - odrasli, adolescenti (12 i više godina) i djeca (6-11 godina). avamys je indiciran za liječenje simptoma alergijskog rinitisa.

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

mcneil healthcare (ireland) limited, tallaght, high street, office 5, 6 & 7, block 5, dublin, irska - ksilometazolinklorid - kapi za nos, otopina - 1 mg/ml - urbroj: jedan ml kapi za nos, otopine sadrži 1 mg ksilometazolinklorida; jedna kap (0,024 ml) sadrži 0,024 mg ksilometazolinklorida