Unió Europea - eslovè - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - 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 - abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. abevmy 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. abevmy 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 abevmy in combination with capecitabine. za nadaljnje informacije o statusu her2 glejte poglavje 5. abevmy, 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. abevmy, 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. abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. abevmy, 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. abevmy, 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. abevmy in combination with paclitaxel, 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. abevmy, 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.

Unió Europea - eslovè - EMA (European Medicines Agency)

mylan ire healthcare limited - 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 - treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Unió Europea - eslovè - EMA (European Medicines Agency)

amneal pharma europe ltd - levodopa, carbidopa - parkinsonova bolezen - anti-parkinsonska zdravila - simptomatsko zdravljenje odraslih bolnikov s parkinsonovo boleznijo.

Unió Europea - eslovè - EMA (European Medicines Agency)

akcea therapeutics ireland limited - volanesorsen natrijev - hiperlipoproteinemija tipa i - drugih lipidov spreminjanje agenti - waylivra je indicirano kot dodatek k dieti pri odraslih bolnikih z gensko potrdili družinsko chylomicronemia sindrom (fcs) in na visoko tveganje za pankreatitisa, v kateri je odziv na dieto in trigliceridov znižanje terapija je bila neustrezna.

Unió Europea - eslovè - EMA (European Medicines Agency)

dompé biotec s.p.a. - darbepoetin alfa - kidney failure, chronic; anemia; cancer - antianemični preparati - zdravljenje simptomatske anemije, povezane s kronično odpovedjo ledvic (crf) pri odraslih in pediatričnih bolnikih. zdravljenje simptomatsko anemija pri odraslih bolnikov z rakom z non-mieloično malignancies, ki prejemajo kemoterapijo.

Eslovènia - eslovè - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

mylan healthcare d.o.o. - ezetimib; rosuvastatin - filmsko obložena tableta - ezetimib 10 mg / 1 tableta  rosuvastatin10 mg / 1 tableta; rosuvastatin 10 mg / 1 tableta - rosuvastatin in ezetimib

Eslovènia - eslovè - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

teva pharma b.v. - rosuvastatin - filmsko obložena tableta - rosuvastatin 10 mg / 1 tableta - rosuvastatin

Eslovènia - eslovè - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

teva pharma b.v. - rosuvastatin - filmsko obložena tableta - rosuvastatin 5 mg / 1 tableta - rosuvastatin

Eslovènia - eslovè - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

teva pharma b.v. - rosuvastatin - filmsko obložena tableta - rosuvastatin 40 mg / 1 tableta - rosuvastatin

Eslovènia - eslovè - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

teva pharma b.v. - rosuvastatin - filmsko obložena tableta - rosuvastatin 20 mg / 1 tableta - rosuvastatin