Evropska unija - slovenščina - EMA (European Medicines Agency)

stada arzneimittel ag - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastična sredstva - oyavas in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. oyavas in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. za nadaljnje informacije o statusu receptorja človeškega epidermičnega rastnega faktorja 2 (her2) glejte poglavje 5. oyavas in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with oyavas in combination with capecitabine. za nadaljnje informacije o statusu her2 glejte poglavje 5. oyavas, 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. oyavas, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non squamous non small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. oyavas in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. oyavas, 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 iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. oyavas, 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. oyavas, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents (see section 5. oyavas, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Evropska unija - slovenščina - EMA (European Medicines Agency)

united therapeutics europe ltd - dinutuximab - neuroblastom - antineoplastična sredstva - unituxin je indicirano za zdravljenje z visokim tveganjem neuroblastoma pri bolnikih, starih 12 mesecev, da 17years, ki so predhodno prejeli indukcijska kemoterapija in doseči vsaj delni odgovor, sledi myeloablative terapije in avtologna izvornih celic presaditev (asct). uporablja se v kombinaciji z granulocitnim makrofagom, ki spodbuja kolonijo (gm-csf), interlevkin-2 (il-2) in izotretinoin.

Evropska unija - slovenščina - EMA (European Medicines Agency)

janssen-cilag international nv - kanaglifozin - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 in 5.

Evropska unija - slovenščina - EMA (European Medicines Agency)

bayer ag - sorafenib - carcinoma, hepatocellular; carcinoma, renal cell - antineoplastična sredstva - hepatocellular carcinomanexavar je primerna za zdravljenje hepatocellular carcinoma. karcinomom carcinomanexavar je indiciran za zdravljenje bolnikov z napredovalim karcinomom ledvičnih, ki je ni pred interferon-alfa ali interleukin-2, ki temelji terapijo ali so neprimeren za takšne terapije. diferencirana ščitnice carcinomanexavar je indiciran za zdravljenje bolnikov z napredujočo, lokalno napredno ali metastatskim, diferencirana (papillary/folikularni/hürthle celic) karcinom ščitnice, ognjevzdržni, da radioaktivnega joda.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mirum pharmaceuticals international b.v. - maralixibat chloride - alagille syndrome - other drugs for bile therapy - livmarli is indicated for the treatment of cholestatic pruritus in patients with alagille syndrome (algs) 2 months of age and older.

Evropska unija - slovenščina - EMA (European Medicines Agency)

servier (ireland) industries ltd - agomelatine - depresivna motnja, major - psychoanaleptics, - zdravljenje velikih depresivnih epizod pri odraslih.

Evropska unija - slovenščina - EMA (European Medicines Agency)

les laboratoires servier - agomelatine - depresivna motnja, major - psychoanaleptics, - zdravljenje velikih depresivnih epizod pri odraslih.

Evropska unija - slovenščina - EMA (European Medicines Agency)

ipsen pharma - cabozantinib (s)-malate - carcinoma, renal cell; carcinomas, hepatocellular - antineoplastična sredstva - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (vegf)-targeted therapy. cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.

Evropska unija - slovenščina - EMA (European Medicines Agency)

bayer ag - finerenone - renal insufficiency, chronic; diabetes mellitus, type 2 - sredstva, ki delujejo na sistem renin-angiotenzin - kerendia is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.

Slovenija - slovenščina - Ecolab

ecolab deutschland gmbh -