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

mylan s.a.s., 117 allee des parcs, saint priest, francuska - travoprostum, timololum - kapi za oko, otopina - 40 mikrograma/ml + 5 mg/ml - urbroj: svaki ml otopine sadrži 40 mikrograma travoprosta i 5 mg timolola (u obliku timololmaleata)

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

instituto grifols, s.a., c/can guasch, 2, pol. ind. levante, parets del valles, barcelona, Španjolska - albumin ljudski - otopina za infuziju - 200 g/l - urbroj: 1000 ml otopine za infuzju sadrži ukupno 200 g proteina, od kojeg je najmanje 95% ljudski albumin

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

instituto grifols, s.a., c/can guasch, 2, pol. ind. levante, parets del valles, barcelona, Španjolska - albumin ljudski - otopina za infuziju - 50 g/l - urbroj: 1000 ml otopine za infuzju sadrži ukupno 50 g proteina, od kojeg je najmanje 95% ljudski albumin

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

instituto grifols, s.a., c/can guasch, 2, pol. ind. levante, parets del valles, barcelona, Španjolska - koagulacijski faktor viii, ljudski von willebrandov faktor, ljudski - prašak i otapalo za otopinu za injekciju / infuziju - 100 iu fviii/ml - urbroj: jedna bočica s praškom nominalno sadrži 1000 iuili 1500 iu humanog koagulacijskog faktora viii i 1200 iu ili 1800 iu humanog von willebrandovog faktora 1 ml otopine nakon rekonstitucije sadrži otprilike 100 iu humanog koagulacijskog faktora viii i 120 iu humanog von willebrandovog faktora

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

instituto grifols, s.a., c/can guasch, 2, pol. ind. levante, parets del valles, barcelona, Španjolska - koagulacijski faktor viii, ljudski von willebrandov faktor, ljudski - prašak i otapalo za otopinu za injekciju / infuziju - 25 iu fviii/ml - urbroj: jedna bočica s praškom nominalno sadrži 250 iu humanog koagulacijskog faktora viii i 300 iu humanog von willebrandovog faktora 1 ml otopine nakon rekonstitucije sadrži otprilike 25 iu humanog koagulacijskog faktora viii i 30 iu humanog von willebrandovog faktora

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

instituto grifols, s.a., c/can guasch, 2, pol. ind. levante, parets del valles, barcelona, Španjolska - koagulacijski faktor viii, ljudski von willebrandov faktor, ljudski - prašak i otapalo za otopinu za injekciju / infuziju - 50 iu fviii/ml - urbroj: jedna bočica s praškom nominalno sadrži 500 iu humanog koagulacijskog faktora viii i 600 iu humanog von willebrandovog faktora 1 ml otopine nakon rekonstitucije sadrži otprilike 50 iu humanog koagulacijskog faktora viii i 60 iu humanog von willebrandovog faktora

Liên Minh Châu Âu - Tiếng Croatia - EMA (European Medicines Agency)

eli lilly nederland b.v. - selpercatinib - carcinoma, non-small-cell lung; thyroid neoplasms - antineoplastična sredstva - retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced ret-mutant medullary thyroid cancer (mtc)advanced ret fusion-positive non-small cell lung cancer (nsclc) not previously treated with a ret inhibitoradvanced ret fusion-positive thyroid cancer who require systematic therapy following prior treatment.

Liên Minh Châu Âu - Tiếng Croatia - EMA (European Medicines Agency)

koanaa healthcare gmbh - иматиниба мезилат - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastična sredstva - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. pacijenti koji imaju niske ili vrlo nizak rizik od recidiva, ne bi trebali primati adjuvantne terapije. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. osim po prvi put prijavljene kronične fazi kml, nema kontroliranih istraživanja pokazuju klinički učinak ili povećava stopu preživljavanja kod te bolesti.

Liên Minh Châu Âu - Tiếng Croatia - 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.

Liên Minh Châu Âu - Tiếng Croatia - EMA (European Medicines Agency)

astellas pharma europe b.v. - roxadustat - anemia; kidney failure, chronic - antianemijski pripravci - evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (ckd).