Union européenne - slovène - EMA (European Medicines Agency)

astellas pharma europe b.v. - enzalutamid - prostatične neoplazme - endokrini terapija - xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (see section 5. the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc) (see section 5. the treatment of adult men with metastatic crpc who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.

Union européenne - slovène - 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 v kombinaciji s kemoterapijo na osnovi fluoropirimidina je indiciran za zdravljenje odraslih bolnikov z metastatskim karcinomom debelega črevesa ali danke. bevacizumab je v kombinaciji z paclitaxel je določen za prvo linijo za zdravljenje odraslih bolnikov z metastatskim rakom dojke,. za nadaljnje informacije o statusu receptorja človeškega epidermičnega rastnega faktorja 2 (her2) glejte poglavje 5. bevacizumab je v kombinaciji z capecitabine je določen za prvo linijo za zdravljenje odraslih bolnikov z metastatskim rakom dojke, pri katerih zdravljenje z drugimi kemoterapijo možnosti, vključno z taxanes ali anthracyclines se ne šteje za primerno. 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. za nadaljnje informacije o statusu her2 glejte poglavje 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. bevacizumab je v kombinaciji z erlotinib, je označen za prvo linijo zdravljenja odraslih bolnikih z unresectable napredno, metastatskega ali ponavljajoče se non-skvamoznih non-small cell lung cancer z epidermalna rastni dejavnik receptorjev (egfr) aktiviranjem 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. bevacizumab je v kombinaciji z paclitaxel in cisplatin, ali, alternativno, paclitaxel in topotecan pri bolnikih, ki ne morejo prejemati platinum terapija je primerna za zdravljenje odraslih bolnikov z vztrajno, periodično, ali metastatskim karcinom materničnega vratu.

Union européenne - slovène - EMA (European Medicines Agency)

astellas pharma europe b.v. - mirabegron - sečnega mehurja, čezmerno - urološki - simptomatsko zdravljenje nujnosti. povečalo micturition pogostost in / ali nujnost inkontinenca kot se lahko zgodi pri odraslih bolnikih s čezmerno aktivnega sečnega-mehurja sindrom.

Union européenne - slovène - EMA (European Medicines Agency)

therakind (europe) limited - metotreksat - arthritis, psoriatic; precursor cell lymphoblastic leukemia-lymphoma; psoriasis; arthritis, rheumatoid; arthritis - antineoplastična sredstva - v rheumatological in dermatološki diseasesactive revmatoidni artritis pri odraslih bolnikih,. polyarthritic oblike aktivno, hudo mladoletnike idiopatsko artritis (jia) pri mladostnikih in otrocih, starih 3 leta in več, ko je odgovor, da nesteroidna protivnetna zdravila (nesteroidnih protivnetnih zdravil), je bil neustrezen. hudo, zdravljenje-ognjevarni, onemogočanje luskavica, ki se ne odziva dovolj na druge oblike zdravljenja, kot so fototerapijo, psoralen in ultravijolično sevanje (puva) terapija in retinoidi, in hudo psoriatičnega artritisa pri odraslih bolnikih,. v oncologymaintenance zdravljenje acute lymphoblastic levkemijo (all) pri odraslih, mladostnikih in otrocih, starih 3 leta in več.

Union européenne - slovène - EMA (European Medicines Agency)

pharmaxis europe limited - manitol - cistična fibroza - kašelj in hladni pripravki - bronchitol je primerna za zdravljenje cistična fibroza (cf) pri odraslih, starih 18 let in več kot dodatna terapija za najboljši standard oskrbe.

Union européenne - slovène - EMA (European Medicines Agency)

astellas pharma europe b.v. - roxadustat - anemia; kidney failure, chronic - antianemični preparati - evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (ckd).

Slovénie - slovène - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

paladin labs europe limited - paracetamol; tramadol - tableta s podaljšanim sproščanjem - paracetamol 650 mg / 1 tableta  tramadol65,88 mg / 1 tableta; tramadol 65,88 mg / 1 tableta - tramadol, kombinacije

Union européenne - slovène - EMA (European Medicines Agency)

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

Slovénie - slovène - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

aspen pharma trading limited - kalcijev nadroparinat - raztopina za injiciranje - kalcijev nadroparinat 9500 i.e. / 1 ml - nadroparin

Union européenne - slovène - EMA (European Medicines Agency)

allergan pharmaceuticals international limited - eluxadoline - irritable bowel syndrome; diarrhea - antidiarrheals, črevesne protivnetna / antiinfective agenti - truberzi je indiciran pri odraslih za zdravljenje sindroma razdražljivega črevesa z drisko (ibs d).