Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

berlin-chemie ag, glienicker weg 125, berlin, njemačka - gusti ekstrakt sabalovog ploda (9-11:1), ekstrakcijsko otapalo: etanol 96% v/v - kapsula, meka - 320 mg - urbroj: 1 meka kapsula sadrži 320 mg ekstrakta (kao gusti ekstrakt) iz serenoa repens (w. bartram) small (sabal serrulata (michaux)), fructus (sabalov plod) (9–11 : 1); ekstrakcijsko otapalo: etanol 96 % v/v

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

farmis d.o.o. sarajevo - paracetamol, tramadol - filmom obložena tableta - 37.5 mg/1 tableta+ 325 mg/1 tableta - jedna filmom obložena tableta sadrži: 37,5 mg tramadol hidrohlorida 325 mg paracetamola

Europska Unija - hrvatski - EMA (European Medicines Agency)

immedica pharma ab - glicerol fenilbutirat - poremećaji ciklusa ureje, umrli - drugi gastrointestinalni trakt i metabolizam, lijekovi, - ravicti prikazan na primjenu kao dodatna terapija za liječenje kroničnih bolesnika urea ciklusa poremećaja (ucds), uključujući nedostatke карбамоильную fosfat-sintaze-ja (sp), ornitin carbamoyltransferase (otn), argininosuccinate синтетазы (stražnjicu), argininosuccinate ЛиАЗы (АСЛ), аргиназы sam (aug) i ornitin translocase deficit hyperornithinaemia-hyperammonaemia homocitrullinuria sindrom (ННН), koje se ne može upravljati s hranom proteina ograničenje i/ili aminokiselinskih dodataka u miru. ravicti treba koristiti uz ograničenje proteina i, u nekim slučajevima, prehrambenih dodataka (e. , esencijalne aminokiseline, arginin, citrulin, dodatke bez kalorija bez proteina).

Europska Unija - hrvatski - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - antineoplastična sredstva - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

csl behring gmbh - ljudski normalni imunoglobulin (ivig) - purpura, thrombocytopenic, idiopathic; bone marrow transplantation; immunologic deficiency syndromes; guillain-barre syndrome; mucocutaneous lymph node syndrome - imuni serumi i homologna, - hormonske terapije kod odraslih i djece i adolescenata (0-18 godina): primarne imunodeficijencije (pid) sindromi s kršenjem антителообразования;hypogammaglobulinaemia i rekurentne bakterijske infekcije u bolesnika s kroničnim лимфолейкозом, u kojima su preventivni antibiotici nisu pomogli;hypogammaglobulinaemia i рецидивирующих bakterijskih infekcija kod plato faza-nekoliko bolesnika, koji nisu uspjeli odgovoriti na пневмококковой cijepljenja;hypogammaglobulinaemia u bolesnika nakon аллогенной transplantacije hematopoetski organi-transplantacija matičnih stanica (ТГСК);urođeni aids-a s рецидивирующими bakterijske infekcije. Иммуномодуляция kod odraslih, i kod djece i adolescenata (0-18 godina): primarni imunološki trombocitopenija (ihs), u bolesnika s visokim rizikom od krvarenja ili prije operacije za podešavanje broja trombocita u krvi;sindrom Гийена-barre;bolest kawasaki;kronična upalna демиелинизирующая полинейропатия (ХВДП). samo je ograničeno iskustvo s korištenjem intravenski imunoglobulini, kod djece s ХВДП.

Europska Unija - hrvatski - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - deksametazon - macular edema; uveitis - ophthalmologicals, other ophthalmologicals - Озурдекс indiciran za liječenje odraslih bolesnika s макулярным oticanjem nakon odvajanja mrežnice beča окклюзия (brvo) ili središnje vene mrežnice окклюзия (crvo). Озурдекс indiciran za liječenje odraslih bolesnika s upala stražnjeg segmenta oka, predstavljajući kao неинфекционный uveitis. Озурдекс indiciran za liječenje odraslih bolesnika s oštećenjem vida zbog dijabetes pomagala макулярного edema (ДМО), koji артифакии ili koga smatraju da je nedovoljno fleksibilan ili neprikladan za nepušače кортикостероидной terapija.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult 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. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the 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. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. 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 dfsp. 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. .

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

merck sharp & dohme bh d.o.o. - pembrolizumab - prašak za koncentrat za rastvor za infuziju - 50 mg/1 bočica - 1 bočica praška za kocentrat za rastvor za infuziju sadrži: 50 mg pembrolizumaba

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

merck sharp & dohme bh d.o.o. - pembrolizumab - koncentrat za rastvor za infuziju - 25 mg/1 ml - 1 bočica sa 4 ml koncentrata za rastvor za infuziju sadrži: 100 mg pembrolizumaba

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

merck sharp & dohme bh d.o.o. - pembrolizumab - koncentrat za rastvor za infuziju - 25 mg/1 ml - 1 bočica sa 4 ml koncentrata za rastvor za infuziju sadrži: 100 mg pembrolizumaba