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

juno pharmaceuticals pty ltd - bendamustine hydrochloride, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - first-line treatment of chronic lymphocytic leukaemia (binet stage b or c). efficacy relative to first-line therapies other than chlorambucil has not been established.,previously untreated indolent cd20-positive, stage iii-iv non-hodgkin?s lymphoma, in combination with rituximab.,previously untreated cd20-positive, stage iii-iv mantle cell lymphoma in combination with rituximab, in patient?s ineligible for autologous stem cell transplantation.,relapsed/refractory indolent non-hodgkin?s lymphoma.

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

juno pharmaceuticals pty ltd - bendamustine hydrochloride, quantity: 25 mg - injection, powder for - excipient ingredients: mannitol - first-line treatment of chronic lymphocytic leukaemia (binet stage b or c). efficacy relative to first-line therapies other than chlorambucil has not been established.,previously untreated indolent cd20-positive, stage iii-iv non-hodgkin?s lymphoma, in combination with rituximab.,previously untreated cd20-positive, stage iii-iv mantle cell lymphoma in combination with rituximab, in patient?s ineligible for autologous stem cell transplantation.,relapsed/refractory indolent non-hodgkin?s lymphoma.

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

sandoz pty ltd - bendamustine hydrochloride monohydrate, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - first-line treatment of chronic lymphocytic leukaemia (binet stage b or c). efficacy relative to first- line therapies other than chlorambucil has not been established.,previously untreated indolent cd20-positive, stage iii-iv non-hodgkin?s lymphoma, in combination with rituximab.,previously untreated cd20-positive, stage iii-iv mantle cell lymphoma in combination with rituximab, in patients ineligible for autologous stem cell transplantation.,relapsed/refractory indolent non-hodgkin?s lymphoma.

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

sandoz pty ltd - bendamustine hydrochloride monohydrate, quantity: 25 mg - injection, powder for - excipient ingredients: mannitol - first-line treatment of chronic lymphocytic leukaemia (binet stage b or c). efficacy relative to first- line therapies other than chlorambucil has not been established.,previously untreated indolent cd20-positive, stage iii-iv non-hodgkin?s lymphoma, in combination with rituximab.,previously untreated cd20-positive, stage iii-iv mantle cell lymphoma in combination with rituximab, in patients ineligible for autologous stem cell transplantation.,relapsed/refractory indolent non-hodgkin?s lymphoma.

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi oncology plc - bendamustine hydrochloride - pdr/conc/soln for infus - 25 milligram - bendamustine

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi oncology plc - bendamustine hydrochloride - pdr/conc/soln for infus - 100 milligram - bendamustine

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

eagle pharmaceuticals, inc - bendamustine hydrochloride (unii: 981y8sx18m) (bendamustine - unii:9266d9p3pq) - bendamustine hydrochloride injection is indicated for the treatment of patients with chronic lymphocytic leukemia. efficacy relative to first line therapies other than chlorambucil has not been established. bendamustine hydrochloride injection is indicated for the treatment of patients with indolent b-cell non-hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. bendamustine hydrochloride injection is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol. [see warnings and precautions (5.3)] pregnancy category d [see warnings and precautions (5.9)] risk summary bendamustine hydrochloride can cause fetal harm when administered to a pregnant woman. bendamustine caused malformations in animals, when a single dose was administered to pregnant animals. advise women to avoid becoming pregnant while receiving be

Malta - English - Medicines Authority

fresenius kabi oncology plc - bendamustine hydrochloride - powder for concentrate for solution for infusion - bendamustine hydrochloride 2.5 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

fresenius kabi oncology plc - bendamustine hydrochloride - powder for concentrate for solution for infusion - bendamustine hydrochloride 2.5 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

accord healthcare limited - bendamustine hydrochloride - powder for concentrate for solution for infusion - bendamustine hydrochloride 2.5 mg/ml - antineoplastic agents