Hemlibra Evropska unija - slovenščina - EMA (European Medicines Agency)

hemlibra

roche registration limited - emicizumab - hemofilija a - antihemoragije - 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 se lahko uporablja v vseh starostnih skupinah.

Rozlytrek Evropska unija - slovenščina - EMA (European Medicines Agency)

rozlytrek

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - antineoplastična sredstva - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

Xofluza Evropska unija - slovenščina - EMA (European Medicines Agency)

xofluza

roche registration gmbh - baloxavir marboxil - gripa, človek - antivirusi za sistemsko uporabo - treatment of influenzaxofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above. post exposure prophylaxis of influenzaxofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above. xofluza should be used in accordance with official recommendations.

Evrysdi Evropska unija - slovenščina - EMA (European Medicines Agency)

evrysdi

roche registration gmbh  - risdiplam - mišična atrofija, hrbtenica - druga zdravila za motnje mišično-skeletnega sistema - evrysdi is indicated for the treatment of 5q spinal muscular atrophy (sma) in patients with a clinical diagnosis of sma type 1, type 2 or type 3 or with one to four smn2 copies.

Enspryng Evropska unija - slovenščina - EMA (European Medicines Agency)

enspryng

roche registration gmbh - satralizumab - neuromyelitis optica - imunosupresivi - satralizumab (enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.

Ronapreve Evropska unija - slovenščina - EMA (European Medicines Agency)

ronapreve

roche registration gmbh  - casirivimab, imdevimab - covid-19 virus infection - imunski sera in imunoglobulini, - ronapreve is indicated for:treatment of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19 (see section 4. prevention of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg (see section 4. the use of ronapreve should take into account information on the activity of ronapreve against viral variants of concern. glej poglavja 4. 4 in 5.