Evrópusambandið - slóvenska - EMA (European Medicines Agency)

fondazione telethon ets - avtologni cd34 + obogaten del celice, ki vsebuje cd34 + celice transduced retrovirusni vektor, ki kodira za ljudi adenozin deaminase (ada) zaporedje cdna iz človeške krvotvornih matičnih/matičnih (cd34 +) celic - huda kombinirana imunska pomanjkljivost - immunostimulants, - strimvelis je indicirano za zdravljenje bolnikov z huda kombinirane imunske pomanjkljivosti zaradi pomanjkanja adenozin deaminase (ada-hu), za katere ni primeren človeških levkocitov antigenov (hla)-ujema povezanih izvornih celic darovalca je na voljo (glej oddelek 4. 2 in oddelek 4.

Evrópusambandið - slóvenska - EMA (European Medicines Agency)

united therapeutics europe ltd - dinutuximab - neuroblastom - antineoplastična sredstva - unituxin je indicirano za zdravljenje z visokim tveganjem neuroblastoma pri bolnikih, starih 12 mesecev, da 17years, ki so predhodno prejeli indukcijska kemoterapija in doseči vsaj delni odgovor, sledi myeloablative terapije in avtologna izvornih celic presaditev (asct). uporablja se v kombinaciji z granulocitnim makrofagom, ki spodbuja kolonijo (gm-csf), interlevkin-2 (il-2) in izotretinoin.

Evrópusambandið - slóvenska - EMA (European Medicines Agency)

takeda pharma a/s - alogliptin - diabetes mellitus, tip 2 - drugs used in diabetes, dipeptidyl peptidase 4 (dpp-4) inhibitors - vipidia je navedeno pri odraslih, starih 18 let in starejši s sladkorno boleznijo tipa 2 za izboljšanje nadzora glycaemic v kombinaciji z drugimi glukoze, zniževanje zdravila, vključno z insulinom, ko ti, skupaj z dieto in telesno vadbo, ne zagotavljajo ustrezne glycaemic nadzor (glej točki 4. 4, 4. 5 in 5. 1 za razpoložljive podatke o različnih kombinacijah).

Evrópusambandið - slóvenska - EMA (European Medicines Agency)

pfizer ireland pharmaceuticals - avibactam sodium, ceftazidime pentahydrate - pneumonia, bacterial; soft tissue infections; pneumonia; urinary tract infections; gram-negative bacterial infections - antibacterials za sistemsko uporabo, - zavicefta is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections:complicated intra-abdominal infection (ciai)complicated urinary tract infection (cuti), including pyelonephritishospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap)treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. zavicefta is also indicated for the treatment of infections due to aerobic gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options. upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti.

Evrópusambandið - slóvenska - EMA (European Medicines Agency)

gedeon richter - kariprazinijev klorid - shizofrenija - psiholeptiki - zdravilo reagila je indicirano za zdravljenje shizofrenije pri odraslih bolnikih.

Evrópusambandið - slóvenska - EMA (European Medicines Agency)

gilead sciences ireland uc - bictegravir, emtricitabine, tenofovir alafenamide, fumarate - okužbe z virusom hiv - antivirusi za sistemsko uporabo - biktarvy is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection in adults and paediatric patients at least 2 years of age and weighing at least 14 kg i without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir. (glejte poglavje 5).

Evrópusambandið - slóvenska - EMA (European Medicines Agency)

pfizer europe ma eeig - talazoparib - neoplazme dojke - antineoplastična sredstva - talzenna je označen kot monotherapy za zdravljenje odraslih bolnikov z germline brca1/2 mutacije, ki so her2-negativne lokalno napredno ali metastatskega raka dojke. patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. bolniki z hormon receptorjev (hr)-pozitivnega raka dojk, je bilo treba ravnati predhodno endokrine, ki temelji terapije, ali neprimerna za endokrine, ki temelji terapija.

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boehringer ingelheim vetmedica gmbh - afoxolaner - ektoparaziticidi za sistemsko uporabo - psi - zdravljenje bolh (ctenocephalides felis in c. canis) infestations. izdelek se lahko uporablja kot del strategije zdravljenja za nadzor alergijskega dermatitisa bolha (fad). zdravljenje klopi (dermacentor reticulatus, ixodes ricinus, rhipicephalus sanguineus) infestations. zdravljenje demodicosis (zaradi demodex canis). zdravljenje sarcoptic mange (zaradi sarcoptes scabiei var. canis).

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pfizer europe ma eeig - dacomitinib monohidrat - karcinom, pljučni pljuč - antineoplastična sredstva - vizimpro, kot monotherapy, je označen za prvo linijo za zdravljenje odraslih bolnikov z lokalno napredno ali metastatskim non small cell lung cancer (nsclc) z epidermalna rastni dejavnik receptorjev (egfr) aktiviranjem mutacije.

Evrópusambandið - slóvenska - EMA (European Medicines Agency)

gilead sciences ireland uc, galapagos nv - filgotinib maleate - artritis, revmatoidni - imunosupresivi - rheumatoid arthritisjyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). jyseleca may be used as monotherapy or in combination with methotrexate (mtx). ulcerative colitisjyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.