Evropská unie - slovinština - 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.

Evropská unie - slovinština - 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.

Evropská unie - slovinština - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - 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 - vegzelma in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. vegzelma 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. vegzelma 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 vegzelma in combination with capecitabine. za nadaljnje informacije o statusu her2 glejte poglavje 5. vegzelma, 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 (nsclc) other than predominantly squamous cell histology. vegzelma, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent nsclc with epidermal growth factor receptor (egfr) activating mutations (see section 5. vegzelma, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. vegzelma, 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. vegzelma, 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 vascular endothelial growth factor (vegf) inhibitors or vegf receptor–targeted agents. vegzelma 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. vegzelma, 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.

Slovinsko - slovinština - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

pfizer luxembourg sarl - doksiciklin - disperzibilna tableta - doksiciklin 100 mg / 1 tableta - doksiciklin

Slovinsko - slovinština - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

pfizer luxembourg sarl - doksiciklin - disperzibilna tableta - doksiciklin 100 mg / 1 tableta - doksiciklin

Slovinsko - slovinština - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

eurovet animal health bv -

Evropská unie - slovinština - EMA (European Medicines Agency)

roche registration gmbh - bevacizumab - carcinoma, non-small-cell lung; breast neoplasms; ovarian neoplasms; colorectal neoplasms; 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 dodatne informacije, kot na človeško epidermalna rast factor receptor 2 (her2) stanje. 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. bolnike, ki so v obdobju 12 mesecev prejemali zdravljenje, ki vsebuje zdravljenje s taksanom in antraciklinom v dodatku, je treba izključiti iz zdravljenja z zdravilom avastin v kombinaciji s kapecitabinom. za nadaljnje informacije, kot da her2 status. bevacizumab, poleg platinum, ki temelji kemoterapijo, je označen za prvo linijo zdravljenja odraslih bolnikih z unresectable napredno, metastatskega ali ponavljajoče se non-small cell lung cancer razen pretežno skvamoznih celic histologija. 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 je v kombinaciji z interferonom alfa-2a, ki je navedena za prvi vrstici zdravljenje odraslih bolnikov z napredno in/ali metastatskim karcinomom raka. bevacizumab je v kombinaciji z carboplatin in paclitaxel je označena na sprednji strani-line zdravljenje odraslih bolnikov z napredovalim (international federation of porodništva in ginekologije (figo) faze iii b, iii c in iv) epitelnih jajčnikov, fallopian tube, ali primarni trebušno raka. bevacizumab je v kombinaciji z carboplatin in gemcitabine, je indicirano za zdravljenje odraslih bolnikov s prvo ponovitev platinum-občutljive epitelnih jajčnikov, fallopian tube ali primarni trebušno raka, ki še niso prejeli pred terapijo z bevacizumab ali drugih vegf inhibitorji ali vegf receptor–ciljno agenti. bevacizumab je v kombinaciji z paclitaxel, topotecan, ali pegylated liposomal doxorubicin je indiciran za zdravljenje odraslih bolnikov s platino-odporne periodično epitelnih jajčnikov, fallopian tube, ali primarni trebušno raka, ki so prejeli več kot dve pred kemoterapijo regimens in ki ga še niso prejeli pred terapijo z bevacizumab ali drugih vegf inhibitorji ali vegf receptor–ciljno agenti. 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.

Evropská unie - slovinština - EMA (European Medicines Agency)

eisai gmbh - eribulin - breast neoplasms; liposarcoma - antineoplastična sredstva - monoterapija halaven je indicirana za zdravljenje bolnikov z lokalno napredovalim ali metastatskim rakom dojke, ki so napredovali po vsaj enem kemoterapevtskem režimu za napredno bolezen (glejte poglavje 5. predhodno zdravljenje bi moralo vključevati antraciklin in taksan, razen če bolniki niso bili primerni za te tretmaje. halaven je indiciran za zdravljenje odraslih bolnikov z unresectable liposarcoma, ki jih prejeli v pred anthracycline, ki vsebujejo terapija (razen če neprimerne) za napredno ali metastatskim bolezni (glej poglavje 5.

Evropská unie - slovinština - EMA (European Medicines Agency)

astrazeneca ab - olaparib - ovarijske neoplazme - antineoplastična sredstva - ciste na cancerlynparza je označen kot monotherapy za:vzdrževanje zdravljenje odraslih bolnikov z napredovalim (figo fazah iii in iv) brca1/2-mutiral (germline in/ali somatski) high-grade epitelnih jajčnikov, fallopian tube ali primarni trebušno raka, ki so v odziv (popolna ali delna) po koncu prve vrstice platinum, ki temelji kemoterapijo. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 in 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. bolniki morajo imeti predhodno že bili zdravljeni z anthracycline in taxane v (neo)adjuvant ali metastatskim nastavitev, če bolniki niso bili primerni za temi postopki (glej točko 5. bolniki z hormon receptorjev (hr)-pozitivnega raka dojk, je treba tudi napredovala na ali po predhodnem endokrine terapije, ali neprimerna za endokrine terapija. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Evropská unie - slovinština - EMA (European Medicines Agency)

novartis europharm limited - lapatinib - neoplazme dojke - proteinska kinaza inhibitorji - tyverb je indiciran za zdravljenje bolnikov z rakom dojke, katerih tumorji, overexpress her2 (erbb2):v kombinaciji z capecitabine za bolnike z napredovalim ali metastatskim bolezni s napredovanje po predhodnem terapijo, ki mora biti vključeni anthracyclines in taxanes in terapija s trastuzumab v metastatskim nastavitev;v kombinaciji z trastuzumab za bolnike z hormon-receptor-negativne metastatskim bolezen, ki je napredovala na predhodno trastuzumab zdravljenja ali terapije v kombinaciji s kemoterapijo;v kombinaciji z zaviralec aromataze za ženske po menopavzi z hormon-receptor-pozitivno metastatskim bolezni, ki trenutno niso namenjene za kemoterapijo. bolniki v registraciji študija prej niso bili zdravljeni z trastuzumab ali zaviralec aromataze. ni na voljo so podatki o učinkovitosti te kombinacije glede na trastuzumab v kombinaciji z zaviralec aromataze v tem bolnik prebivalstva.