Hemlibra Europos Sąjunga - rumunų - EMA (European Medicines Agency)

hemlibra

roche registration limited - emicizumab - hemofilia a - hemostatice - 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 poate fi folosit în toate grupele de vârstă.

Pegasys 135 mcg/0,5 ml soluţie injectabilă în seringă preumplută Moldova - rumunų - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

pegasys 135 mcg/0,5 ml soluţie injectabilă în seringă preumplută

f.hoffmann-la roche, ltd. - peginterferon alfa-2a - soluţie injectabilă în seringă preumplută - 135 mcg/0,5 ml

Pegasys 180 mcg/0,5 ml soluţie injectabilă în seringă preumplută Moldova - rumunų - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

pegasys 180 mcg/0,5 ml soluţie injectabilă în seringă preumplută

f.hoffmann-la roche, ltd. - peginterferon alfa-2a - soluţie injectabilă în seringă preumplută - 180 mcg/0,5 ml

Polivy Europos Sąjunga - rumunų - EMA (European Medicines Agency)

polivy

roche registration gmbh - polatuzumab brentuximab - limfom cu celule b - agenți antineoplazici - polivy în combinație cu bendamustina și rituximab este indicat pentru tratamentul pacienților adulți cu recăderi/refractară diffuse large b-cell lymphoma (dlbcl) care nu sunt candidați pentru transplant de celule stem hematopoietice. 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 Europos Sąjunga - rumunų - EMA (European Medicines Agency)

rozlytrek

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - agenți antineoplazici - 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.

Evrysdi Europos Sąjunga - rumunų - EMA (European Medicines Agency)

evrysdi

roche registration gmbh  - risdiplam - atrofia musculară, spinală - alte medicamente pentru tulburări ale sistemului musculo-scheletic - 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 Europos Sąjunga - rumunų - EMA (European Medicines Agency)

enspryng

roche registration gmbh - satralizumab - neuromyelitis optica - imunosupresoare - 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 Europos Sąjunga - rumunų - EMA (European Medicines Agency)

ronapreve

roche registration gmbh  - casirivimab, imdevimab - covid-19 virus infection - seruri imune și imunoglobuline, - 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. vezi secțiunile 4. 4 și 5.