European Union - Estonian - EMA (European Medicines Agency)

alexion europe sas - eculizumab - hemoglobinuuria, paroksüsmaalne - immunosupressandid - soliris on näidatud täiskasvanute ja laste raviks:paroxysmal öise haemoglobinuria (pnh). tõendeid kliinilise kasu on näidanud patsientidel haemolysis kliiniliste sümptomite(s) soovituslik kõrge haiguse aktiivsusega, sõltumata sellest, vereülekande ajalugu (vt lõik 5. ebatüüpiline hemolüütilis-ureemilise sündroomi (ahus). soliris on näidustatud täiskasvanute raviks:tulekindlad generaliseerunud myasthenia gravis (gmg) patsientidel, kes on anti-atsetüülkoliin retseptori (achr) antikeha-positiivsete (vt lõik 5. neuromyelitis optica spectrum disorder (nmosd) patsientidel, kes on anti-aquaporin-4 (aqp4) antikeha-positiivsete koos relapsing haiguse kulg.

European Union - Estonian - EMA (European Medicines Agency)

biogen netherlands b.v. - natalisumab - hulgiskleroos - selektiivsed immunosupressandid - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 ja 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

European Union - Estonian - EMA (European Medicines Agency)

pfizer europe ma eeig - inotuzumab ozogamicin - prekursorko-lümfoblastne leukeemia-lümfoom - antineoplastilised ained - besponsa on monoteraapiana retsidiveerunud või tuleohtliku cd22-positiivse b-rakulise prekursori ägeda lümfoblastilise leukeemia (all) täiskasvanute raviks.. täiskasvanud patsientidel, kellel philadelphia kromosoomiga positiivse (ph+) taastekkinud või tulekindlad b-raku eellased kÕik peaks olema ebaõnnestunud ravi vähemalt 1 türosiinkinaasi inhibiitor (tki).

European Union - Estonian - EMA (European Medicines Agency)

leo pharma a/s - brodalumab - psoriaas - immunosupressandid - kyntheum on näidustatud mõõduka kuni raske naastulise psoriaasi raviks täiskasvanud patsientidel, kes saavad süsteemset ravi.

European Union - Estonian - EMA (European Medicines Agency)

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - dermatiidi ained, välja arvatud kortikosteroidid - 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.

European Union - Estonian - EMA (European Medicines Agency)

roche registration gmbh - ocrelizumab - hulgiskleroos - immunosupressandid - täiskasvanud patsientidel, kellel on kliinilistes või pildistamisfunktsioonides määratletud aktiivne haigus koos hulgiskleroosiga (rms). ravi täiskasvanud patsientidel varajases primaarne progresseeruv sclerosis multiplex (ppms) seoses haiguse kestus ja puude, ja koos pildistamine funktsioone iseloomulik põletikuline aktiivsus.

European Union - Estonian - EMA (European Medicines Agency)

roche registration gmbh - atezolüsumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - antineoplastilised ained - urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancer tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5. tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous nsclc who do not have egfr mutant or alk positive nsclc (see section 5. tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq nagu monotherapy on näidustatud ravi täiskasvanud patsientidel, kellel on lokaalselt kaugelearenenud või metastaatilise mitteväikerakk-kopsuvähi pärast eelnevat keemiaravi. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc) (see section 5. hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have not received prior systemic therapy (see section 5. urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancertecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq nagu monotherapy on näidustatud ravi täiskasvanud patsientidel, kellel on lokaalselt kaugelearenenud või metastaatilise mitteväikerakk-kopsuvähi pärast eelnevat keemiaravi. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. triple-negative breast cancertecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumours have pd-l1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

European Union - Estonian - EMA (European Medicines Agency)

janssen-cilag international nv - guselkumab - psoriaas - immunosupressandid - 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.

European Union - Estonian - EMA (European Medicines Agency)

roche registration limited - emicizumab - hemofiilia a. - antihemorraagilised ained - hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia a (congenital factor viii deficiency):with factor viii inhibitorswithout factor viii inhibitors who have:severe disease (fviii < 1%)moderate disease (fviii ≥ 1% and ≤ 5%) with severe bleeding phenotype. hemlibra saab kasutada kõigis vanuserühmades.

European Union - Estonian - EMA (European Medicines Agency)

pfizer europe ma eeig - gemtuzumab ozogamicin - leukeemia, müeloidne, äge - antineoplastilised ained - mylotarg on näidustatud kombineeritud ravi daunorubicin (dpl) ja cytarabine (arac) raviks patsientidel vanuses 15 aastat ja üle selle eelnevalt ravimata, de novo cd33-positiivse akuutse müeloidse leukeemia (aml), välja arvatud äge promyelocytic leukeemia (avp).