Evropska unija - slovenščina - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - cannabidiol - lennox gastaut syndrome; epilepsies, myoclonic - antiepileptics, - epidyolex je primerna za uporabo kot adjunctive zdravljenje epileptičnih, povezanih z lennox gastaut sindrom (lgs) ali dravet sindrom (ds), v povezavi z papir, za bolnike 2 let in starejši.

Evropska unija - slovenščina - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - crisantaspase - predkroglomerna limfoblastna levkemija limfoma - antineoplastična sredstva - enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (all) and lymphoblastic lymphoma (lbl) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to e. coli-derived asparaginase.

Evropska unija - slovenščina - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - daunorubicin hydrochloride, cytarabine - leukemija, myeloid, akutna - antineoplastična sredstva - vyxeos liposomal je indiciran za zdravljenje odraslih z novo diagnozo, terapijo, povezanih z akutno mieloično levkemijo (t-aml) ali aml z myelodysplasia povezane spremembe (aml-mrc).

Evropska unija - slovenščina - EMA (European Medicines Agency)

gentium s.r.l. - defibrotid - hepatična veno-okluzivna bolezen - antitrombotična sredstva - defitelio je indicirano za zdravljenje hudo jetrno veno-okluzivne bolezni (vod), znan tudi kot sinusoidno obstruktivna sindrom (sos) v hematopoetske izvornih celic presaditev (hsct) terapija. to je navedeno v odrasle in mladostnike, otroke in dojenčke od 1 meseca starosti.

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

shire pharmaceuticals ireland limited - lantan - žvečljiva tableta - lantan 1000 mg / 1 tableta - lantanov(iii) karbonat

Evropska unija - slovenščina - EMA (European Medicines Agency)

crealta pharmaceuticals ireland limited - pegloticaza - protin - antigout pripravki - krystexxa je indicirano za zdravljenje hude izčrpavajoče kronične tophaceous protina pri odraslih bolnikih, ki imajo tudi erozivnih skupno udeležbo in ki ni bilo mogoče normalizirati seruma sečne kisline z ksantin monoaminooksidaze največja medicinsko primerno odmerek ali za katere so kontraindicirana teh zdravil.

Evropska unija - slovenščina - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cistična fibroza - drugi proizvodi dihal - orkambi tablete so primerna za zdravljenje cistična fibroza (cf) pri bolnikih, starih 6 let in več, ki so homozygous za f508del mutacije v cftr gena. orkambi granules are indicated for the treatment of cystic fibrosis (cf) in children aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

Evropska unija - slovenščina - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - cistična fibroza - drugi proizvodi dihal - 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - cistična fibroza - drugi proizvodi dihal - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

amarin pharmaceuticals ireland limited - icosapent ethyl - dislipidemije - sredstva za spreminjanje lipidov - indicated to reduce cardiovascular risk as an adjunct to statin therapy.