Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

f. hoffmann-la roche ltd. 4303 kaiseraugst- batch releaser - obinutuzumab - concentrate for solution for infusion - 1000mg/40ml

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

f. hoffmann-la roche ltd. 4303 kaiseraugs- secondary packager - obinutuzumab - concentrate for solution for infusion - 1000mg/40ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

roche products ltd - obinutuzumab - solution for infusion - 25mg/1ml

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - obinutuzumab - leukemia, lymphocytic, chronic, b-cell - antineoplastic agents - chronic lymphocytic leukaemia (cll)gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) and with comorbidities making them unsuitable for full-dose fludarabine based therapy (see section 5.1).follicular lymphoma (fl)gazyvaro in combination with chemotherapy, followed by gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced follicular lymphoma.gazyvaro in combination with bendamustine followed by gazyvaro maintenance is indicated for the treatment of patients with follicular lymphoma (fl) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

roche, switzerland - obinutuzumab - concentrate for solution for infusion - 25 mg/ml

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - obinutuzumab 1000mg - concentrate for infusion - 1000 mg - active: obinutuzumab 1000mg excipient: histidine poloxamer 188 trehalose dihydrate water for injection - gazyva in combination with chlorambucil is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (cll).