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)

novartis europharm limited - rivastigmin - dementia; alzheimer disease; parkinson disease - psychoanaleptics, - simptomatsko liječenje blage do umjereno teške alzheimerove demencije. simptomatsko liječenje blage do umjereno teške demencije kod pacijenata sa idiopatskom parkinsonovom bolešću.

Europska Unija - hrvatski - EMA (European Medicines Agency)

extrovis eu ltd. - lakozamida - epilepsija - antiepileptici sredstva, - lacosamide adroiq is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. lacosamide adroiq is indicated as adjunctive therapyin the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cistična fibroza - drugi proizvodi respiratornog sustava - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 i 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 i 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

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

elektroničar d.o.o. karlovačka cesta 26/a 10000 zagreb -

Europska Unija - hrvatski - EMA (European Medicines Agency)

mylan pharmaceuticals limited - besilate amlodipin, валсартан - hipertenzija - sredstva koja djeluju na sustav renin-angiotenzina - liječenje esencijalne hipertenzije. amlodipin/Валсартан mylan navedene u odraslih, kod kojih je krvni pritisak nije dovoljno prati na amlodipin ili валсартан kao monoterapija.

Europska Unija - hrvatski - EMA (European Medicines Agency)

novartis europharm limited - valsartan, amlodipine (as amlodipine besilate) - hipertenzija - sredstva koja djeluju na sustav renin-angiotenzina - liječenje esencijalne hipertenzije. copalia indiciran kod pacijenata kod kojih je krvni pritisak nije dovoljno prati na amlodipin ili валсартан kao monoterapija.

Europska Unija - hrvatski - EMA (European Medicines Agency)

novartis europharm limited - amlodipin, валсартан - hipertenzija - sredstva koja djeluju na sustav renin-angiotenzina - liječenje esencijalne hipertenzije. dafiro indiciran kod pacijenata kod kojih je krvni pritisak nije dovoljno prati na amlodipin ili валсартан kao monoterapija.

Europska Unija - hrvatski - EMA (European Medicines Agency)

novartis europharm limited - valsartan, hydrochlorothiazide, amlodipine besilate - hipertenzija - sredstva koja djeluju na sustav renin-angiotenzina - liječenje esencijalne hipertenzije kao zamjena terapija u odraslih bolesnika čiji krvni tlak odgovarajuće kontroliran na kombinaciji amlodipin, valsartan i hidroklorotiazid (hct), uzeti kao tri pojedinačnih formulacije ili je dvojan-komponenta i pojedinačnih formulacija.

Europska Unija - hrvatski - EMA (European Medicines Agency)

novartis europharm limited - valsartan, amlodipine (as amlodipine besilate) - hipertenzija - sredstva koja djeluju na sustav renin-angiotenzina - liječenje esencijalne hipertenzije. exforge indiciran kod pacijenata kod kojih je krvni pritisak nije dovoljno prati na amlodipin ili валсартан kao monoterapija.