Eiropas Savienība - slovēņu - EMA (European Medicines Agency)

novartis europharm limited - ribociklib sukcinat - neoplazme dojke - antineoplastična sredstva - kisqali je primerna za zdravljenje žensk z hormon receptorjev (hr)‑pozitiven, human epidermalna rast factor receptor 2 (her2)‑negativna lokalno napredno ali metastatskega raka dojke, v kombinaciji z zaviralec aromataze ali fulvestrant kot začetno endokrine temelji na zdravljenje, ali pri ženskah, ki jih prejeli v pred endokrine terapija. v pre‑ ali perimenopausal ženske, endokrini terapija je treba v kombinaciji z luteinising hormon sproščujoči hormon (lhrh) agonist.

Eiropas Savienība - slovēņu - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - antineoplastična sredstva - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. , as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Eiropas Savienība - slovēņu - EMA (European Medicines Agency)

gedeon richter plc. - ulipristal acetat - leiomyoma - spolni hormoni in zdravila genitalni sistem, - ulipristal acetata, ki je navedena za eno zdravljenje, seveda pre-operative zdravljenje zmerne do hude simptome maternice fibroids v odrasle ženske v rodni dobi. ulipristal acetata je primerna za občasno zdravljenje zmerne do hude simptome maternice fibroids v izobraževanje žensk v rodni dobi, ki niso primerni za operacijo.

Slovēnija - slovēņu - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

dechra regulatory -

Eiropas Savienība - slovēņu - EMA (European Medicines Agency)

novartis europharm limited  - alpelisib - neoplazme dojke - antineoplastična sredstva - piqray je navedeno v kombinaciji z fulvestrant za zdravljenje pri ženskah po menopavzi, in moški, hormonski receptor (hr)-pozitiven, human epidermalna rast factor receptor 2 (her2)-negativna, lokalno napredno ali metastatskega raka dojke z pik3ca mutacije po napredovanja bolezni naslednje endokrine terapije kot monotherapy (glej poglavje 5.

Eiropas Savienība - slovēņu - EMA (European Medicines Agency)

bristol myers squibb pharma eeig - luspatercept - anemia; myelodysplastic syndromes; beta-thalassemia - drugi antianemic priprave - reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (mds) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (see section 5. reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia (see section 5.

Eiropas Savienība - slovēņu - EMA (European Medicines Agency)

eurogenerics holdings b.v. - teriparatid - osteoporoza - kalcij homeostaza - qutavina is indicated in adults. zdravljenje osteoporoze pri ženskah po menopavzi in pri moških z večjim tveganjem zloma. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. zdravljenje osteoporoze, povezane s trajno sistemsko glukokortikoidnih terapija pri ženskah in moških na povečano tveganje za zlom.

Eiropas Savienība - slovēņu - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriparatid - osteoporoza - kalcij homeostaza - sondelbay is indicated in adults. zdravljenje osteoporoze pri ženskah po menopavzi in pri moških z večjim tveganjem zloma. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. zdravljenje osteoporoze, povezane s trajno sistemsko glukokortikoidnih terapija pri ženskah in moških na povečano tveganje za zlom.

Eiropas Savienība - slovēņu - EMA (European Medicines Agency)

theramex ireland limited - abaloparatide - osteoporosis, postmenopausal; osteoporosis - kalcij homeostaza - zdravljenje osteoporoze pri ženskah po menopavzi pri večjem tveganju zloma.