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

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

Croatia - Croatian - HALMED (Agencija za lijekove i medicinske proizvode)

krka - farma d.o.o., radnička cesta 48, zagreb - бензокаин-može, cetylpyridinii klorida - pastila - 5 mg + 1 mg - urbroj: svaka pastila sadrži 5 mg benzokaina i 1 mg cetilpiridinijevog klorida

European Union - Croatian - EMA (European Medicines Agency)

eurocept international b. v. - par-аминосалициловая kiselina - tuberkuloza - antimikobakterija - granupas je indiciran za uporabu kao dio odgovarajući kombiniranom za multi-rezistentna tuberkuloza u odraslih i pedijatrijskih bolesnika od 28 dana starosti i starije kada učinkovite terapije ne može inače biti sastoji iz razloga otpor ili podnošljivost (vidjeti dio 4.. treba uzeti u obzir formalne preporuke za odgovarajuće korištenje antibakterijskih posrednika.

Croatia - Croatian - HALMED (Agencija za lijekove i medicinske proizvode)

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb, hrvatska - kalcijev folinat hidrat - otopina za injekciju/infuziju - 10 mg/ml - urbroj: 1 ml otopine za injekciju sadrži 10 mg folinatne kiseline u obliku kalcijevog folinata

Croatia - Croatian - HALMED (Agencija za lijekove i medicinske proizvode)

sandoz d.o.o., maksimirska 120, zagreb, hrvatska - kalcijev folinat hidrat - otopina za injekciju/infuziju - 10 mg/ml - urbroj: jedan ml otopine za injekciju/infuziju sadrži 10 mg folinatne kiseline u obliku kalcijevog folinat hidrata

Croatia - Croatian - HALMED (Agencija za lijekove i medicinske proizvode)

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb, hrvatska - amoksicilinnatrij kalijev klavulanat - prašak za otopinu za injekciju / infuziju - 1000 mg + 200 mg - urbroj: jedna bočica sadrži 1000 mg amoksicilina u obliku amoksicilinnatrija i 200 mg klavulanske kiseline u obliku kalijevog klavulanata

Croatia - Croatian - HALMED (Agencija za lijekove i medicinske proizvode)

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb, hrvatska - amoksicilinnatrij kalijev klavulanat - prašak za otopinu za injekciju ili infuziju - 500 mg + 100 mg - urbroj: jedna bočica sadrži 500 mg amoksicilina u obliku amoksicilinnatrija i 100 mg klavulanske kiseline u obliku kalijevog klavulanata

Croatia - Croatian - HALMED (Agencija za lijekove i medicinske proizvode)

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb, hrvatska - amoksicilin trihidrat kalijev klavulanat - tableta za oralnu suspenziju/raspadljiva tableta za usta - 875 mg + 125 mg - urbroj: 1 tableta sadrži 875 mg amoksicilina u obliku amoksicilin trihidrata i 125 mg klavulanatne kiseline u obliku kalijevog klavulanata

Croatia - Croatian - HALMED (Agencija za lijekove i medicinske proizvode)

sandoz d.o.o., maksimirska 120, zagreb, hrvatska - amoksicilinnatrij kalijev klavulanat - prašak za otopinu za injekciju/infuziju - 1000 mg + 200 mg - urbroj: jedna bočica sadrži 1000 mg amoksicilina (u obliku natrijeve soli) i 200 mg klavulanske kiseline (u obliku kalijeve soli)