Ocrevus האיחוד האירופי - פינית - EMA (European Medicines Agency)

ocrevus

roche registration gmbh - ocrelizumab - multippeliskleroosi - immunosuppressantit - hoidetaan aikuispotilaita, joilla on relapsoiva multippeliskleroosi (rms), ja kliinisten tai kuvantamisominaisuuksien määrittelemä aktiivinen sairaus. aikuisille potilaille, joilla on varhainen ensisijainen progressiivinen multippeliskleroosi (ppm) osalta taudin kesto ja taso vammaisuuden, ja kuvantamisen ominaisuuksia ominaista inflammatorinen aktiivisuus.

Hemlibra האיחוד האירופי - פינית - EMA (European Medicines Agency)

hemlibra

roche registration limited - emicizumab - hemofilia a - hemostaatit - 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 voidaan käyttää kaikissa ikäryhmissä.

Polivy האיחוד האירופי - פינית - EMA (European Medicines Agency)

polivy

roche registration gmbh - polatuzumab vedotin - lymfooma, b-solu - antineoplastiset aineet - polivy yhdessä bendamustiinin ja rituksimabi on tarkoitettu aikuisille potilaille, joilla oli uusiutunut/vaikeahoitoinen hajanainen suuri b-solu lymfooma (dlbcl), jotka eivät ole ehdokkaita vertamuodostavan kudoksen kantasolujen siirto. 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).

Rozlytrek האיחוד האירופי - פינית - EMA (European Medicines Agency)

rozlytrek

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - antineoplastiset aineet - 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 האיחוד האירופי - פינית - EMA (European Medicines Agency)

xofluza

roche registration gmbh - baloxavir marboxil - influenssa, ihminen - antiviraalit systeemiseen käyttöön - 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.

Phesgo האיחוד האירופי - פינית - EMA (European Medicines Agency)

phesgo

roche registration gmbh - pertuzumab, trastuzumab - rintojen kasvaimet - antineoplastiset aineet - early breast cancer (ebc)phesgo is indicated for use in combination with chemotherapy in:the neoadjuvant treatment of adult patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrencethe adjuvant treatment of adult patients with her2-positive early breast cancer at high risk of recurrencemetastatic breast cancer (mbc)phesgo is indicated for use in combination with docetaxel in adult patients with her2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-her2 therapy or chemotherapy for their metastatic disease.

Evrysdi האיחוד האירופי - פינית - EMA (European Medicines Agency)

evrysdi

roche registration gmbh  - risdiplam - lihassärky, spinaali - muut lääkkeet liikuntaelinten sairauksien häiriöihin - 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 האיחוד האירופי - פינית - EMA (European Medicines Agency)

enspryng

roche registration gmbh - satralizumab - neuromyelitis optica - immunosuppressantit - 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 האיחוד האירופי - פינית - EMA (European Medicines Agency)

ronapreve

roche registration gmbh  - casirivimab, imdevimab - covid-19 virus infection - immunoseerumit ja immunoglobuliinit, - 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. katso kohdat 4. 4 ja 5.

Gavreto האיחוד האירופי - פינית - EMA (European Medicines Agency)

gavreto

roche registration gmbh  - pralsetinib - karsinooma, ei-pienisoluinen keuhko - antineoplastiset aineet - 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.