ProteqFlu Uni Eropa - Kroasia - EMA (European Medicines Agency)

proteqflu

boehringer ingelheim vetmedica gmbh - virus pds 2242 virus / virus vcp1529 / vcp1533 virus / vcp3011 - imunomodulatori, žive virusne vakcine virusa influence konja - konji - aktivna imunizacija konja od četiri mjeseca ili starije od konjske gripe radi smanjenja kliničkih znakova i izlučivanja virusa nakon infekcije.

SYNFLORIX 1 µg/0.5 mL+ 3 µg/0.5 mL+ 1 µg/0.5 mL+ 1 µg/0.5 mL+ 1 µg/0.5 mL+ 1 µg/0.5 mL+ 1 µg/0.5 mL+ 3 µg/0.5 mL+ 3 µg/0.5 mL+ 1 Bosnia dan Herzegovina - Kroasia - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

synflorix 1 µg/0.5 ml+ 3 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 3 µg/0.5 ml+ 3 µg/0.5 ml+ 1

glaxosmithkline d.o.o.sarajevo - pneumokokus, prečišćeni polisaharidni диагностикум sam hemofilus utjecaj, konjugovani - suspenzija za injekciju - 1 µg/0.5 ml+ 3 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 3 µg/0.5 ml+ 3 µg/0.5 ml+ 1 µg/0.5 ml - 1doza (0,5 ml) suspenzije za injekciju sadrži: pneumokokni polisaharid serotip 11, 2 1 mikrogram pneumokokni polisaharid serotip 41, 2 3 mikrograma pneumokokni polisaharid serotip 51, 2 1 mikrogram pneumokokni polisaharid serotip 6b1, 2 1 mikrogram pneumokokni polisaharid serotip 7f1, 2 1 mikrogram pneumokokni polisaharid serotip 9v1, 2 1 mikrogram pneumokokni polisaharid serotip 141, 2 1 mikrogram pneumokokni polisaharid serotip 18c1, 3 3 mikrograma pneumokokni polisaharid serotip 19f1, 4 3 mikrograma pneumokokni polisaharid serotip 23f1, 2 1 mikrogram 1 adsorbovan na aluminijum fosfat 0,5 mg al3+ 2 konjugovan na protein d (dobijen iz netipiziranog haemophilus influenzae) kao proteinski nosač 916 mikrograma 3 konjugovan na toksoid tetanusa kao proteinski nosač 510 mikrograma 4 konjugovan na toksoid difterije kao proteinski nosač 36 mikrograma

SYNFLORIX 1 µg/0.5 mL+ 3 µg/0.5 mL+ 1 µg/0.5 mL+ 1 µg/0.5 mL+ 1 µg/0.5 mL+ 1 µg/0.5 mL+ 1 µg/0.5 mL+ 3 µg/0.5 mL+ 3 µg/0.5 mL+ 1 Bosnia dan Herzegovina - Kroasia - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

synflorix 1 µg/0.5 ml+ 3 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 3 µg/0.5 ml+ 3 µg/0.5 ml+ 1

glaxosmithkline d.o.o.sarajevo - pneumokokus, prečišćeni polisaharidni диагностикум sam hemofilus utjecaj, konjugovani - suspenzija za injekciju - 1 µg/0.5 ml+ 3 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 3 µg/0.5 ml+ 3 µg/0.5 ml+ 1 µg/0.5 ml - 1doza (0,5 ml) suspenzije za injekciju sadrži: pneumokokni polisaharid serotip 11, 2 1 mikrogram pneumokokni polisaharid serotip 41, 2 3 mikrograma pneumokokni polisaharid serotip 51, 2 1 mikrogram pneumokokni polisaharid serotip 6b1, 2 1 mikrogram pneumokokni polisaharid serotip 7f1, 2 1 mikrogram pneumokokni polisaharid serotip 9v1, 2 1 mikrogram pneumokokni polisaharid serotip 141, 2 1 mikrogram pneumokokni polisaharid serotip 18c1, 3 3 mikrograma pneumokokni polisaharid serotip 19f1, 4 3 mikrograma pneumokokni polisaharid serotip 23f1, 2 1 mikrogram 1 adsorbovan na aluminijum fosfat 0,5 mg al3+ 2 konjugovan na protein d (dobijen iz netipiziranog haemophilus influenzae) kao proteinski nosač 916 mikrograma 3 konjugovan na toksoid tetanusa kao proteinski nosač 510 mikrograma 4 konjugovan na toksoid difterije kao proteinski nosač 36 mikrograma

SYNFLORIX 1 µg/0.5 mL+ 3 µg/0.5 mL+ 1 µg/0.5 mL+ 1 µg/0.5 mL+ 1 µg/0.5 mL+ 1 µg/0.5 mL+ 1 µg/0.5 mL+ 3 µg/0.5 mL+ 3 µg/0.5 mL+ 1 Bosnia dan Herzegovina - Kroasia - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

synflorix 1 µg/0.5 ml+ 3 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 3 µg/0.5 ml+ 3 µg/0.5 ml+ 1

evropa lijek pharma d.o.o. - pneumokokus, prečišćeni polisaharidni диагностикум sam hemofilus utjecaj, konjugovani - suspenzija za injekciju - 1 µg/0.5 ml+ 3 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 3 µg/0.5 ml+ 3 µg/0.5 ml+ 1 µg/0.5 ml - 1doza (0,5 ml) suspenzije za injekciju sadrži: pneumokokni polisaharid serotip 11, 2 1 mikrogram pneumokokni polisaharid serotip 41, 2 3 mikrograma pneumokokni polisaharid serotip 51, 2 1 mikrogram pneumokokni polisaharid serotip 6b1, 2 1 mikrogram pneumokokni polisaharid serotip 7f1, 2 1 mikrogram pneumokokni polisaharid serotip 9v1, 2 1 mikrogram pneumokokni polisaharid serotip 141, 2 1 mikrogram pneumokokni polisaharid serotip 18c1, 3 3 mikrograma pneumokokni polisaharid serotip 19f1, 4 3 mikrograma pneumokokni polisaharid serotip 23f1, 2 1 mikrogram 1 adsorbovan na aluminijum fosfat 0,5 mg al3+ 2 konjugovan na protein d (dobijen iz netipiziranog haemophilus influenzae) kao proteinski nosač 916 mikrograma 3 konjugovan na toksoid tetanusa kao proteinski nosač 510 mikrograma 4 konjugovan na toksoid difterije kao proteinski nosač 36 mikrograma

SYNFLORIX 1 µg/0.5 mL+ 3 µg/0.5 mL+ 1 µg/0.5 mL+ 1 µg/0.5 mL+ 1 µg/0.5 mL+ 1 µg/0.5 mL+ 1 µg/0.5 mL+ 3 µg/0.5 mL+ 3 µg/0.5 mL+ 1 Bosnia dan Herzegovina - Kroasia - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

synflorix 1 µg/0.5 ml+ 3 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 3 µg/0.5 ml+ 3 µg/0.5 ml+ 1

evropa lijek pharma d.o.o. - pneumokokus, prečišćeni polisaharidni диагностикум sam hemofilus utjecaj, konjugovani - suspenzija za injekciju - 1 µg/0.5 ml+ 3 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 1 µg/0.5 ml+ 3 µg/0.5 ml+ 3 µg/0.5 ml+ 1 µg/0.5 ml - 1doza (0,5 ml) suspenzije za injekciju sadrži: pneumokokni polisaharid serotip 11, 2 1 mikrogram pneumokokni polisaharid serotip 41, 2 3 mikrograma pneumokokni polisaharid serotip 51, 2 1 mikrogram pneumokokni polisaharid serotip 6b1, 2 1 mikrogram pneumokokni polisaharid serotip 7f1, 2 1 mikrogram pneumokokni polisaharid serotip 9v1, 2 1 mikrogram pneumokokni polisaharid serotip 141, 2 1 mikrogram pneumokokni polisaharid serotip 18c1, 3 3 mikrograma pneumokokni polisaharid serotip 19f1, 4 3 mikrograma pneumokokni polisaharid serotip 23f1, 2 1 mikrogram 1 adsorbovan na aluminijum fosfat 0,5 mg al3+ 2 konjugovan na protein d (dobijen iz netipiziranog haemophilus influenzae) kao proteinski nosač 916 mikrograma 3 konjugovan na toksoid tetanusa kao proteinski nosač 510 mikrograma 4 konjugovan na toksoid difterije kao proteinski nosač 36 mikrograma

Aybintio Uni Eropa - Kroasia - EMA (European Medicines Agency)

aybintio

samsung bioepis nl b.v. - 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 - aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. aybintio in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. za daljnje informacije o stanju čovjeka epidermalnog faktora rasta receptora 2 (her2), molimo pogledajte odjeljak 5. 1 of the smpc. aybintio 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 anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with aybintio in combination with capecitabine. dodatne informacije o statusu her2 potražite u odjeljku 5. 1 of the smpc. aybintio, 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. aybintio, 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. 1 of the smpc). aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. aybintio, 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. 1 of the smpc). aybintio, 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. aybintio, 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. 1 of the smpc). aybintio, 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. 1 of the smpc).

Equidacent Uni Eropa - Kroasia - EMA (European Medicines Agency)

equidacent

centus biotherapeutics europe limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell - antineoplastična sredstva - bevacizumab u kombinaciji s kemoterapijom na bazi fluoropirimidina je indiciran za liječenje odraslih bolesnika s metastatskim karcinomom debelog crijeva ili rektuma. Бевацизумаб u kombinaciji s паклитакселом dizajniran za prvu liniju tretmana odraslih pacijenata s metastaze raka dojke . za daljnje informacije o stanju čovjeka epidermalnog faktora rasta receptora 2 (her2), molimo pogledajte odjeljak 5. Бевацизумаб u kombinaciji s капецитабином dizajniran za prvu liniju terapije bolesnika s metastaze raka dojke kod kojih je liječenje s drugim opcijama kemoterapije, uključujući таксаны ili антрациклины, smatra se neprikladnim. 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. dodatne informacije o statusu her2 potražite u odjeljku 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. Бевацизумаб u kombinaciji s эрлотинибом, prikazan je za prva linija terapije kod odraslih pacijenata s нерезектабельными-najčešće metastaze ili recidivom неороговевающий немелкоклеточного raka pluća s epidermalnog faktora rasta (egfr) aktiviraju 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. Бевацизумаб u kombinaciji s паклитакселом i цисплатином ili паклитакселом i топотеканом kod pacijenata koji ne mogu dobiti платиновую terapiju, indiciran za liječenje odraslih bolesnika s uporni, relaps ili метастатической карциномой grlića maternice.

Onbevzi Uni Eropa - Kroasia - EMA (European Medicines Agency)

onbevzi

samsung bioepis nl b.v. - 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 - onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. onbevzi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. za daljnje informacije o stanju čovjeka epidermalnog faktora rasta receptora 2 (her2), molimo pogledajte odjeljak 5. onbevzi 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 onbevzi in combination with capecitabine. dodatne informacije o statusu her2 potražite u odjeljku 5. onbevzi, 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. onbevzi, 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. onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. onbevzi, 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. onbevzi, 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. onbevzi, 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. onbevzi, 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.

Alymsys Uni Eropa - Kroasia - EMA (European Medicines Agency)

alymsys

mabxience research sl - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastična sredstva - alymsys in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. alymsys in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. alymsys 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 alymsys in combination with capecitabine. alymsys, 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. alymsys, 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. alymsys in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. alymsys, 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. alymsys, 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. alymsys, 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. alymsys, 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.

Oyavas Uni Eropa - Kroasia - EMA (European Medicines Agency)

oyavas

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 daljnje informacije o stanju čovjeka epidermalnog faktora rasta receptora 2 (her2), molimo pogledajte odjeljak 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. dodatne informacije o statusu her2 potražite u odjeljku 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.