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

sonimed d.o.o. rozganska 8 10110 zagreb -

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

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)

krka farma d.o.o. sarajevo - kapecitabin - filmom obložena tableta - 150 mg/1 tableta - 1 filmom obložena tableta sadrži: 150 mg kapecitabin

Hrvatska - hrvatski - Ecolab

ecolab deutschland gmbh -

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

actavis group ptc ehf, reykjavikurvegur 76-78, hafnarfjordur, island - linezolidum - filmom obložena tableta - 600 mg - urbroj: svaka tableta sadrži 600 mg linezolida

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

teva b.v., swensweg 5, haarlem, nizozemska - vildagliptinum, metformin - filmom obložena tableta - 50 mg + 1000 mg - urbroj: svaka filmom obložena tableta sadrži 50 mg vildagliptina i 1000 mg metforminklorida (što odgovara 780 mg metformina)

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

teva b.v., swensweg 5, haarlem, nizozemska - vildagliptinum, metformin - filmom obložena tableta - 50 mg + 850 mg - urbroj: svaka filmom obložena tableta sadrži 50 mg vildagliptina i 850 mg metforminklorida (što odgovara 660 mg metformina)