Europska Unija - hrvatski - EMA (European Medicines Agency)

ceva santé animale - torasemide - visoki strop diuretici, sulfonamidima, uobičajena - psi - za liječenje kliničkih znakova povezanih s kongestivnog zatajenja srca kod pasa, uključujući i edem pluća.

Europska Unija - hrvatski - EMA (European Medicines Agency)

sandoz gmbh - pegfilgrastim - neutropenija - Иммуностимуляторы, - smanjenje duljine trajanja neutropenije i incidencije febrilne neutropenije u odraslih bolesnika liječenih citotoksičnom kemoterapijom zbog zloćudne bolesti (uz iznimku kronične mijeloične leukemije i mijelodisplastičnog sindroma).

Europska Unija - hrvatski - EMA (European Medicines Agency)

novartis europharm limited  - voretigene neparvovec - leber congenital amaurosis; retinitis pigmentosa - other ophthalmologicals - luxturna je indiciran za liječenje i odjelu odraslih bolesnika s gubitkom vida zbog ostavština distrofije mrežnice uzrokovana potvrdio rpe65 биаллельных mutacija i koji imaju dovoljno živih stanica mrežnice.

Europska Unija - hrvatski - EMA (European Medicines Agency)

akcea therapeutics ireland limited - volanesorsen natrija - hyperlipoproteinemia type i - drugi гиполипидемические modificiranje - waylivra prikazan kao dodatak prehrani kod odraslih pacijenata s genetski potvrdio obiteljska chylomicronemia sindrom (dvs) i visok rizik za razvoj pankreatitis, u kojima je odgovor na prehrane i trigliceridi антигипертензивная terapija je bila neadekvatna.

Europska Unija - hrvatski - EMA (European Medicines Agency)

atnahs pharma netherlands b.v. - solriamfetol hidroklorid - narcolepsy; sleep apnea, obstructive - psychoanaleptics, - sunosi pokazala da poboljšanje budnosti i smanjiti prekomjerna dnevna pospanost u odraslih bolesnika s narkolepsije (sa ili bez cataplexy). sunosi pokazala da poboljšanje budnosti i smanjiti prekomjerna dnevna pospanost (eds) kod odraslih pacijenata sa sindromom opstruktivna sleep apnea (osa), kod kojih je ЭЦП je nedovoljno obrađenih osnovnih osa terapija, kao što su kontinuirani pozitivni tlak u dišnim putevima (cpap stroj).

Europska Unija - hrvatski - EMA (European Medicines Agency)

dechra regulatory b.v. - mirtazapine - psychoanaleptics, antidepressants in combination with psycholeptics - mačke - za povećanje tjelesne težine mačke, doživljava loš apetit i gubitak težine, kao rezultat kronične bolesti.

Europska Unija - hrvatski - EMA (European Medicines Agency)

mylan ire healthcare limited - pretomanid - tuberkuloza, višestruko otporna - antimikobakterija - dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (xdr), or treatment-intolerant or nonresponsive multidrug-resistant (mdr) tuberculosis (tb). treba uzeti u obzir formalne preporuke za odgovarajuće korištenje antibakterijskih posrednika.

Europska Unija - hrvatski - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - neoplazme dojki - antineoplastična sredstva - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

Europska Unija - hrvatski - 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

vifor fresenius medical care renal pharma france - avacopan - microscopic polyangiitis; wegener granulomatosis - imunosupresivi - tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (gpa) or microscopic polyangiitis (mpa).