Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - lakozamida - epilepsija - antiepileptici sredstva, - lacosamide accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. lacosamide accord is indicated as adjunctive therapy•         in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 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)

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

Europska Unija - hrvatski - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - cistična fibroza - drugi proizvodi respiratornog sustava - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - Апиксабан - venous thromboembolism; stroke; arthroplasty - antitrombotska sredstva - prevention of venous thromboembolic events (vte) in adult patients who have undergone elective hip or knee replacement surgery. prevencija moždanog udara i sistemske embolije kod odraslih pacijenata s неклапанной фибрилляцией vrlo značajan (nvaf), s jednim ili više faktora rizika, kao što su moždani udar ili prolazni ishemijski napad (tia); dob ≥ 75 godina; hipertenzija; dijabetes; симптоматическая zatajivanja srca (nyha klase za ≥ drugi). liječenje tromboze dubokih vena (dvt) i plućne embolije (ТЭЛА) i prevenciju recidiva dvt i ТЭЛА kod odraslih (vidi odjeljak 4. 4 za hemodinamski nestabilne ТЭЛА pacijenata). prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (nvaf), with one or more risk factors, such as prior stroke or transient ischaemic attack (tia); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (nyha class ≥ ii). liječenje tromboze dubokih vena (dvt) i plućne embolije (ТЭЛА) i prevenciju recidiva dvt i ТЭЛА kod odraslih (vidi odjeljak 4. 4 za hemodinamski nestabilne ТЭЛА pacijenata).

Europska Unija - hrvatski - EMA (European Medicines Agency)

viiv healthcare b.v. - cabotegavir sodium, cabotegravir - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults who are virologically suppressed (hiv-1 rna.

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

zada pharmaceuticals d.o.o. - paroksetin - film tableta - 20 mg/1 tableta - 1 film tableta sadrži: 20 mg paroksetin (u obliku paroksetin hidrohlorid hemihidrata)

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

zada pharmaceuticals d.o.o. - paroksetin - film tableta - 30 mg/1 tableta - 1 film tableta sadrži: 30 mg paroksetin (u obliku paroksetin hidrohlorid hemihidrata)

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - abirateron acetat - prostatske neoplazme - endokrinska terapija - abiraterone accord is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicatedthe treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antineoplastična sredstva - gastrointestinal stromal tumour (gist)sunitinib accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sunitinib accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sunitinib accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pnet) with disease progression in adults.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastična sredstva - dasatinib accord is indicated for the treatment of adult patients with:• ph+ acute lymphoblastic leukaemia (all) with resistance or intolerance to prior therapy. dasatinib accord is indicated for the treatment of paediatric patients with:• newly diagnosed ph+ all in combination with chemotherapy.