Európska únia - slovenčina - EMA (European Medicines Agency)

roche registration ltd. - daclizumab - graft rejection; kidney transplantation - imunosupresíva - zenapax je indikovaný na profylaxiu akútnej rejekcie odmietnutie de novo allogenic transplantácii obličiek a používať súbežne s imunosupresívneho režimu, vrátane cyklosporínom a kortikosteroidmi u pacientov, ktorí nie sú vysoko imunizované.

Európska únia - slovenčina - EMA (European Medicines Agency)

ceft biopharma s.r.o. - ibritumomab tiuxetan - lymfóm, folikulárny - terapeutické rádiofarmaká - zevalin je indikovaný u dospelých. [90y]-radiolabelled zevalin je označené ako konsolidácie terapie po odpustení indukčné v predtým neliečených pacientov s follicular lymfóm. výhody zevalin nasledujúce rituximab v kombinácii s chemoterapiou nebola stanovená. [90y]-radiolabelled zevalin je indikovaný na liečbu dospelých pacientov s rituximabom relapsedorrefractory cd20+ follicular b-bunkového non-hodgkin je lymfóm (nhl).

Európska únia - slovenčina - EMA (European Medicines Agency)

leo pharma a/s - brodalumab - svrab - imunosupresíva - kyntheum je indikovaný na liečbu stredne ťažkej až ťažkej psoriázy plakov u dospelých pacientov, ktorí sú kandidátmi na systémovú terapiu.

Európska únia - slovenčina - EMA (European Medicines Agency)

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - liečivá na dermatitídu okrem kortikosteroidov - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5. 1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy. eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

Európska únia - slovenčina - EMA (European Medicines Agency)

amgen technology (ireland) uc - bevacizumab - carcinoma, renal cell; peritoneal neoplasms; ovarian neoplasms; breast neoplasms; carcinoma, non-small-cell lung; fallopian tube neoplasms - antineoplastické činidlá - mvasi v kombinácii s chemoterapiou na báze fluoropyrimidínu je indikovaný na liečbu dospelých pacientov s metastatickým karcinómom hrubého čreva alebo konečníka. mvasi v kombinácii s paclitaxel je uvedené v prvej línii liečby dospelých pacientov s metastatického karcinómu prsníka. Ďalšie informácie o stave receptora ľudského epidermálneho rastového faktora 2 (her2) nájdete v časti 5. mvasi, okrem platinum-založené chemoterapia je uvedený na prvej línie liečby dospelých pacientov s unresectable pokročilým, metastatickým alebo recidivujúcim non-small cell lung cancer iné ako prevažne dlaždicových buniek histology. mvasi in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. mvasi, v kombinácii s carboplatin a paclitaxel je uvedené na prednej strane-line liečbu dospelých pacientov s pokročilým (international federation of gynecology a pôrodníctve (figo) etapách iiib, iiic a iv) epitelové vaječníkov, fallopian trubice, alebo primárne peritoneal rakoviny. mvasi, v kombinácii s carboplatin a gemcitabine alebo v kombinácii s carboplatin a paclitaxel, je indikovaný na liečbu dospelých pacientov s prvého opakovania platinum-citlivé epitelové vaječníkov, fallopian trubice alebo primárne peritoneal rakovine, ktorí nedostali pred terapia s bevacizumab alebo iných inhibítorov vegf alebo vegf receptor-cielené agentov. mvasi in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor-targeted agents. mvasi, v kombinácii s paclitaxel a cisplatin, alebo, alternatívne, paclitaxel a topotecan v pacienti, ktorí nemôžu dostávať platinum terapia, je indikovaný na liečbu dospelých pacientov s perzistentné, opakujúce, alebo metastatickým karcinóm krčka maternice.

Európska únia - slovenčina - EMA (European Medicines Agency)

janssen-cilag international nv - guselkumab - svrab - imunosupresíva - plaque psoriasis tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. psoriatic arthritis tremfya, alone or in combination with methotrexate (mtx), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (dmard) therapy (see section 5.

Európska únia - slovenčina - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - burosumab - hypophosphatemia, familial; hypophosphatemic rickets, x-linked dominant; osteomalacia - lieky na liečbu chorôb kostí - 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.

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

baxalta innovations gmbh, rakúsko - faktor viii - inhibítor bypassovej aktivity - 16 - anticoagulantia (fibrinolytica, antifibrinol.)

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

baxalta innovations gmbh, rakúsko - faktor viii - inhibítor bypassovej aktivity - 16 - anticoagulantia (fibrinolytica, antifibrinol.)

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

mylan ire healthcare limited, Írsko - salbutamol - 14 - bronchodilatantia, antiasthmatica