Europska Unija - hrvatski - EMA (European Medicines Agency)

roche registration gmbh - ocrelizumab - multipla skleroza - imunosupresivi - liječenje odraslih bolesnika s relapsirajućim oblicima multiple skleroze (rms) s aktivnim bolestima definiranim kliničkim ili imaging značajkama. liječenje odraslih bolesnika s ranim primarne progresivne multiple skleroze (ППМС) u smislu trajanja bolesti i stupnja invalidnosti, i uz pomoć vizualizacije osobine karakteristične za upalne aktivnosti.

Europska Unija - hrvatski - EMA (European Medicines Agency)

roche registration limited - emicizumab - hemofilija 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 mogu se koristiti u svim dobnim skupinama.

Europska Unija - hrvatski - EMA (European Medicines Agency)

roche registration gmbh - polatuzumab ведотин - limfom, b-stanični - antineoplastična sredstva - Полевий u kombinaciji s Бендамустин i rituksimab je indiciran za liječenje odraslih bolesnika s ponavljajućom/uporan da bi se raspršili u-крупноклеточной limfoma (ДВККЛ), koji nisu kandidati za transplantaciju гемопоэтических transplantacija matičnih stanica. 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).

Europska Unija - hrvatski - EMA (European Medicines Agency)

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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

roche registration gmbh - baloxavir marboxil - gripa, ljudska - antivirusni lijekovi za sustavnu uporabu - 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

roche registration gmbh - pertuzumab, trastuzumab - neoplazme dojki - antineoplastična sredstva - 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

roche registration gmbh  - risdiplam - mišićna atrofija, kralješnica - ostali lijekovi za poremećaje mišićno-koštanog sustava - 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

roche registration gmbh  - casirivimab, imdevimab - covid-19 virus infection - imuni serumi i homologna, - 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. pogledajte odjeljke 4. 4 i 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

roche registration gmbh  - pralsetinib - karcinom, ne-malih stanica pluća - antineoplastična sredstva - 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.