Evropska unija - slovenščina - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - burosumab - hypophosphatemia, familial; hypophosphatemic rickets, x-linked dominant; osteomalacia - zdravila za zdravljenje bolezni kosti - crysvita is indicated for the treatment of x-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults. crysvita is indicated for the treatment of fgf23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.

Evropska unija - slovenščina - EMA (European Medicines Agency)

bioprojet pharma - pitolisant - narcolepsy - druga zdravila na živčnem sistemu - wakix is indicated in adults, adolescents and children from the age of 6 years for the treatment of narcolepsy with or without cataplexy (see also section 5.

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited - secukinumab - arthritis, psoriatic; psoriasis; spondylitis, ankylosing - imunosupresivi - plaque psoriasiscosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old who are candidates for systemic therapy. hidradenitis suppurativa (hs)cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic hs therapy. psoriatični arthritiscosentyx, samostojno ali v kombinaciji z metotreksatom (mtx), je primerna za zdravljenje aktivnega psoriatičnega artritisa pri odraslih bolnikih, kadar je odgovor na prejšnje bolezni spreminjanje anti revmatičnih drog (dmard) terapija je bila neustrezna. aksialni spondyloarthritis (axspa)ankilozirajoči spondilitis (kot, radiografski osno spondyloarthritis)cosentyx je primerna za zdravljenje aktivnega ankilozirajoči spondilitis pri odraslih, ki so se odzvali neustrezno konvencionalne terapije. non-radiographic axial spondyloarthritis (nr-axspa)cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (nsaids). juvenile idiopathic arthritis (jia)enthesitis-related arthritis (era)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. juvenile psoriatic arthritis (jpsa)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

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)

glaxosmithkline (ireland) limited - ambrisentan - hipertenzija, pljučnica - antihipertenzivi, - volibris is indicated for treatment of pulmonary arterial hypertension (pah) in adult patients of who functional class (fc) ii to iii, including use in combination treatment (see section 5.  efficacy has been shown in idiopathic pah (ipah) and in pah associated with connective tissue disease. volibris is indicated for treatment of pah in adolescents and children (aged 8 to less than 18 years) of who functional class (fc) ii to iii including use in combination treatment. efficacy has been shown in ipah, familial, corrected congenital and in pah associated with connective tissue disease (see section 5.

Evropska unija - slovenščina - EMA (European Medicines Agency)

pacira ireland limited - bupivacaine - acute pain - amides, anesthetics, local - exparel liposomal is indicated:in adults as a brachial plexus block or femoral nerve block for treatment of post-operative pain. in adults and children aged 6 years or older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.

Evropska unija - slovenščina - EMA (European Medicines Agency)

advicenne s.a. - potassium citrate monohydrated, potassium hydrogen carbonate - acidosis, renal tubular - mineral supplements - sibnayal is indicated for the treatment of distal renal tubular acidosis (drta) in adults, adolescents and children aged one year and older.

Evropska unija - slovenščina - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - nelarabin - predkroglomerna limfoma t-celična limfoblastna levkemija - antineoplastična sredstva - nelarabine je indiciran za zdravljenje bolnikov z t-celic acute lymphoblastic levkemijo (t-all) in t-celic lymphoblastic limfom (t-lbl), katerih bolezen ni odgovorila, ali je relapsed po zdravljenju z vsaj dvema kemoterapijo regimens. due to the small patient populations in these disease settings, the information to support these indications is based on limited data.

Evropska unija - slovenščina - EMA (European Medicines Agency)

dipharma arzneimittel gmbh - miglustat - gaucher bolezen - drugi proizvodi prebavnega trakta in metabolizma - miglustat dipharma je označen za oralno zdravljenje odraslih bolnikov z blago do zmerno tipa 1 gaucher bolezni. miglustat dipharma se lahko uporablja le pri zdravljenju bolnikov, za katere encim nadomestno zdravljenje, je neustrezna. miglustat dipharma je primerna za zdravljenje progresivne nevrološke manifestacije pri odraslih bolnikih in pediatričnih bolnikih z niemann-pick tip c bolezen.

Evropska unija - slovenščina - EMA (European Medicines Agency)

valneva austria gmbh - covid-19 vaccine (inactivated, adjuvanted, adsorbed) - covid-19 virus infection - cepiva - covid-19 vaccine (inactivated, adjuvanted) valneva is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 to 50 years of age.  the use of this vaccine should be in accordance with official recommendations.