United States - English - NLM (National Library of Medicine)

genentech, inc. - obinutuzumab (unii: o43472u9x8) (obinutuzumab - unii:o43472u9x8) - obinutuzumab 1000 mg in 40 ml - gazyva, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia. gazyva, in combination with bendamustine followed by gazyva monotherapy, is indicated for the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab-containing regimen. gazyva, in combination with chemotherapy followed by gazyva monotherapy in patients achieving at least a partial remission, is indicated for the treatment of adult patients with previously untreated stage ii bulky, iii or iv follicular lymphoma. gazyva is contraindicated in patients with known hypersensitivity reactions (e.g., anaphylaxis) to obinutuzumab or to any of the excipients, or serum sickness with prior obinutuzumab use [see warnings and precautions (5.4)]. risk summary based on findings from animal studies and its mechanism of action, gazyva can cause fetal b-cell depletion [see clinical pharmacology (12.1)] . there are no data with gazyva use in pre

Australia - English - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - obinutuzumab, quantity: 1000 mg - injection, concentrated - excipient ingredients: poloxamer; histidine hydrochloride monohydrate; trehalose dihydrate; water for injections; histidine - chronic lymphocytic leukaemia,gazyva in combination with chlorambucil is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (cll).,follicular lymphoma,gazyva in combination with chemotherapy followed by gazyva maintenance is indicated for the treatment of patients with previously untreated advanced follicular lymphoma.,gazyva in combination with bendamustine, followed by gazyva maintenance, is indicated for the treatment of patients with follicular lymphoma (fl) who did not respond to, or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.,pre-treatment to reduce the risk of cytokine release syndrome (crs) induced by glofitamab,gazyva is indicated as a pre-treatment to reduce the risk of cytokine release syndrome (crs) induced by glofitamab.

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).

Canada - English - Health Canada

hoffmann-la roche limited - obinutuzumab - solution - 25mg - obinutuzumab 25mg - antineoplastic agents

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - obinutuzumab - concentrate for solution for infusion - obinutuzumab 1000 mg / 40 ml - obinutuzumab - chronic lymphocytic leukaemia (cll)gazyva, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (cll).follicular lymphoma (fl )gazyva, in combination with bendamustine followed by gazyva monotherapy, 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 a rituximab-containing regimen.gazyva in combination with chemotherapy, followed by gazyva maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced follicular lymphoma.

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.

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

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - venetoclax - film coated tablets - venetoclax 10 mg - venetoclax - chronic lymphocytic leukemia/small lymphocytic lymphomavenclexta in combination with rituximab or as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll), who have received at least one prior therapy.venclexta in combination with obinutuzumab is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll).acute myeloid leukemiavenclexta in combination with a hypomethylating agent or in combination with low dose cytarabine is indicated for newly diagnosed patients with acute myeloid leukemia (aml) who are ineligible for intensive chemotherapy.