Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration limited - emicizumab - hemophilia a - antihemorrhagics - 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 hægt er að nota í öllum aldri tekur.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration gmbh - polatuzumab vedotin - eitlaæxli, b-klefi - Æxlishemjandi lyf - polivy ásamt bendamustine og rítúxímab er ætlað fyrir meðferð fullorðinn sjúklinga með fallið/svarar dreifð stór b-eitlaæxli (dlbcl) sem eru ekki mönnum fyrir skurðaðgerðir stafa klefi grætt. polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (r-chp) is indicated for the treatment of adult patients with previously untreated diffuse large b-cell lymphoma (dlbcl).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - Æxlishemjandi lyf - 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration gmbh - baloxavir marboxil - inflúensu, manna - veirueyðandi lyf til almennrar notkunar - 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration gmbh - satralizumab - neuromyelitis optica - Ónæmisbælandi lyf - 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration gmbh  - risdiplam - vöðvaáfall, mænu - Önnur lyf við sjúkdómum í stoðkerfi - 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration gmbh  - casirivimab, imdevimab - covid-19 virus infection - Ónæmiskerfið sera og mótefni, - 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. sjá kafla 4. 4 og 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration gmbh  - pralsetinib - krabbamein, lungnakrabbamein - Æxlishemjandi lyf - gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (ret) fusion-positive advanced non-small cell lung cancer (nsclc) not previously treated with a ret inhibitor.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration gmbh - mosunetuzumab - eitilæxli, follicular - antineoplastic agents, monoclonal antibodies - lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (fl) who have received at least two prior systemic therapies.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration gmbh - faricimab - wet macular degeneration; macular edema; diabetes complications - augnlækningar - vabysmo is indicated for the treatment of adult patients with:neovascular (wet) age-related macular degeneration (namd),visual impairment due to diabetic macular oedema (dme).