Den Europæiske Union - slovensk - EMA (European Medicines Agency)

swedish orphan biovitrum international ab - nitizinon - tyrosinemias - drugi zdravljene bolezni prebavil in presnove izdelki, - hereditary tyrosinemia type 1 (ht 1)orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (ht 1) in combination with dietary restriction of tyrosine and phenylalanine. alkaptonuria (aku)orfadin is indicated for the treatment of adult patients with alkaptonuria (aku).

Den Europæiske Union - slovensk - EMA (European Medicines Agency)

immedica pharma ab - glicerol fenilbutirat - motnje cikličnega uda, v rojstvu - drugi zdravljene bolezni prebavil in presnove izdelki, - ravicti je primerna za uporabo kot adjunctive terapijo za kronično upravljanje bolnikov z sečnine cikel motnje (ucds), vključno z pomanjkljivosti carbamoyl fosfat-sintetaze-i (cps), ornitin carbamoyltransferase (otc), argininosuccinate synthetase (rit), argininosuccinate lyase (asl), arginase i (arg) in ornitin translocase pomanjkljivost hyperornithinaemia-hyperammonaemia homocitrullinuria sindrom (hhh), ki ne more biti upravlja prehranskih beljakovin, omejitev in/ali amino kisline, dodatki sam. ravicti je treba uporabljati z prehranskih beljakovin, omejitev in, v nekaterih primerih, prehranskih dopolnilih, (e. , esencialne aminokisline, arginin, citrulin, brezcarinske dodatke kalorij).

Den Europæiske Union - slovensk - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - lanadelumab - angioedem, dedno - other hematological agents - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in patients aged 2 years and older.

Den Europæiske Union - slovensk - 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.

Den Europæiske Union - slovensk - 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.

Den Europæiske Union - slovensk - EMA (European Medicines Agency)

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - imunosupresivi - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.

Den Europæiske Union - slovensk - EMA (European Medicines Agency)

sfl pharmaceuticals deutschland gmbh - nyxthracis - anthrax - imunski sera in imunoglobulini, - obiltoxaximab sfl is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to bacillus anthracis (see section 5. obiltoxaximab sfl is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.

Den Europæiske Union - slovensk - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - gastrointestinalni stromalni tumorji - antineoplastična sredstva - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (gist) who have received prior treatment with three or more kinase inhibitors, including imatinib.

Den Europæiske Union - slovensk - EMA (European Medicines Agency)

astrazeneca ab - selumetinib sulfate - neurofibromatosis 1 - antineoplastična sredstva - koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (pn) in paediatric patients with neurofibromatosis type 1 (nf1) aged 3 years and above.

Den Europæiske Union - slovensk - EMA (European Medicines Agency)

oncopeptides ab - melphalan flufenamide hydrochloride - multiple myeloma - antineoplastična sredstva - pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-cd38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. for patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation (see section 4.