Европейски съюз - словенски - EMA (European Medicines Agency)

novartis europharm limited - canakinumab - cryopyrin-associated periodic syndromes; arthritis, juvenile rheumatoid; arthritis, gouty - interleukin inhibitorji, - redno vročina syndromesilaris je indicirano za zdravljenje naslednjih autoinflammatory redno vročina sindromov, pri odraslih, mladostnikih in otrocih, starih 2 leti in več:cryopyrin-associated periodic syndromesilaris je primerna za zdravljenje cryopyrin-associated periodic sindromov (caps), vključno z:muckle-sindrom wells (mws),novorojenčku-nastop multisystem vnetne bolezni (nomid) / kronične infantilne nevrološke, kožne, sklepni sindrom (cinca),hude oblike družinsko hladno autoinflammatory sindrom (fcas) / družinsko hladno urtikarija (fcu) predstavitev z znaki in simptomi, ki presegajo hladno-induced urticarial izpuščaj na koži,. tumor nekroze faktor receptor, povezanih redno sindrom (pasti)ilaris je primerna za zdravljenje tumor nekroze faktor (tnf), receptor, povezanih redno sindrom (pasti). hyperimmunoglobulin d sindrom (hids)/mevalonate kinaza pomanjkljivosti (mkd)ilaris je primerna za zdravljenje hyperimmunoglobulin d sindrom (hids)/mevalonate kinaza pomanjkljivosti (mkd). družinsko sredozemlju kuge (fmf)ilaris je primerna za zdravljenje družinsko sredozemlju kuge (fmf). ilaris je treba v kombinaciji z colchicine, če je primerno. ilaris je prikazano tudi za zdravljenje:še vedno je diseaseilaris je primerna za zdravljenje aktivnega še vedno je bolezen odraslih, vključno z nastopom še vedno je bolezen (aosd) in sistemsko mladoletnike idiopatsko artritis (sjia) pri bolnikih, starih 2 leti in več, ki so se odzvali neustrezno na prejšnje zdravljenje s nesteroidna protivnetna zdravila (nesteroidnih protivnetnih zdravil) in sistemski kortikosteroidi. ilaris lahko podana kot monotherapy ali v kombinaciji z metotreksatom. uričnim arthritisilaris je primerna za simptomatsko zdravljenje odraslih bolnikov s pogostimi uričnega artritisa napadov (vsaj za 3 napade v zadnjih 12 mesecih) pri katerih nesteroidna protivnetna zdravila (nesteroidnih protivnetnih zdravil) in colchicine so kontraindicirana, se ne prenaša ali ne zagotavlja ustreznega odgovora, in v kateri je ponovil tečaji kortikosteroidi niso primerne.

Европейски съюз - словенски - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ozanimod hidroklorid - multiple sclerosis, relapsing-remitting; colitis, ulcerative - imunosupresivi - multiple sclerosiszeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (rrms) with active disease as defined by clinical or imaging features. ulcerative colitiszeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

Европейски съюз - словенски - EMA (European Medicines Agency)

pfizer europe ma eeig  - rimegepant - bolezni migrene - antimigraine preparations, calcitonin gene-related peptide (cgrp) antagonists - vydura is indicated for theacute treatment of migraine with or without aura in adults;preventative treatment of episodic migraine in adults who have at least 4 migraine attacks per month.

Европейски съюз - словенски - EMA (European Medicines Agency)

extrovis eu ltd. - lakosamid - epilepsija - antiepileptics, - 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.

Европейски съюз - словенски - EMA (European Medicines Agency)

eisai gmbh - lenvatinib mesilat - karcinom, ledvična celica - antineoplastična sredstva - kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (rcc):in combination with pembrolizumab, as first-line treatment (see section 5. in combination with everolimus, following one prior vascular endothelial growth factor (vegf)-targeted therapy.

Европейски съюз - словенски - EMA (European Medicines Agency)

actavis group ptc ehf - reteplaza - miokardni infarkt - antitrombotična sredstva - rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent st elevation or recent left bundle branch block within 12 hours after the onset of acute-myocardial-infarction (ami) symptoms.

Европейски съюз - словенски - EMA (European Medicines Agency)

grünenthal gmbh - lesinurad - hiperurikemija - antigout pripravki - zurampic, v kombinaciji z zaviralec ksantinske oksidaze, je indicirano pri odraslih za dodatno zdravljenje pri bolnikih protina (z ali brez tophi), ki niso dosegli cilj serumu sečne kisline z ustrezno odmerek ksantin-oksidaza hiperurikemija zaviralec sam.

Европейски съюз - словенски - EMA (European Medicines Agency)

biocryst ireland limited - berotralstat dihydrochloride - angioedem, dedno - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.

Европейски съюз - словенски - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - ponatinib - leukemia, myeloid; leukemia, lymphoid - antineoplastic agents, protein kinase inhibitors - iclusig is indicated in adult patients withchronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutationphiladelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation. glej poglavja 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.

Европейски съюз - словенски - EMA (European Medicines Agency)

actavis group ptc ehf - levetiracetam - epilepsija - antiepileptics, - levetiracetam actavis je označen kot monoterapije pri zdravljenju zasegov delno nastopom z ali brez sekundarnega posploševanje pri bolnikih od 16 let z novo diagnosticirano epilepsijo. levetiracetam actavis je označen kot adjunctive terapija:pri zdravljenju delno-nastop napadi z ali brez sekundarne posplošitev v odrasle, otroke in dojenčke od enega meseca starosti z epilepsijo;pri zdravljenju myoclonic zasegov v odrasle in mladostnike od 12. leta starosti z mladoletnimi myoclonic epilepsija;v zdravljenju primarne splošni tonik-clonic zasegov v odrasle in mladostnike od 12. leta starosti z idiopatsko splošnih epilepsijo.