Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - ofatumumab - infusion, solution concentrate - 20.0mg/ml

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - ofatumumab - infusion, solution concentrate - 20.0mg/ml

European Union - English - EMA (European Medicines Agency)

novartis europharm ltd - ofatumumab - leukemia, lymphocytic, chronic, b-cell - monoclonal antibodies - previously untreated chronic lymphocytic leukaemia (cll): arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of patients with cll who have not received prior therapy and who are not eligible for fludarabine-based therapy. relapsed cll: arzerra is indicated in combination with fludarabine and cyclophosphamide for the treatment of adult patients with relapsed cll. refractory cll: arzerra is indicated for the treatment of cll in patients who are refractory to fludarabine and alemtuzumab.,

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - ofatumumab 20 mg/ml - concentrate for solution for infusion - ofatumumab - treatment of chronic lymphocytic leukaemia (cll) in patients who are refractory to fludarabine and alemtuzumab

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - ofatumumab 20 mg/ml - concentrate for solution for infusion - ofatumumab - treatment of chronic lymphocytic leukaemia (cll) in patients who are refractory to fludarabine and alemtuzumab

Israel - English - Ministry of Health

novartis israel ltd - ofatumumab - solution for injection - ofatumumab 50 mg/ml - ofatumumab - kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features

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

novartis pharmaceuticals australia pty ltd - ofatumumab, quantity: 20 mg/ml - injection, concentrated - excipient ingredients: water for injections; hydrochloric acid; sodium chloride; arginine; sodium acetate; disodium edetate; polysorbate 80 - 1. previously untreated cll : arzerra is indicated, in combination with chlorambucil or bendamustine, for the treatment of patients with chronic lymphocytic leukaemia (cll) who have not received prior therapy and are inappropriate for fludarabine-based therapy.,2. refractory cll: arzerra, as a single agent, is indicated for the treatment of patients chronic lymphocytic leukaemia (cll) refractory to fludarabine and alemtuzumab.

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

novartis pharmaceuticals australia pty ltd - ofatumumab, quantity: 20 mg/ml - injection, concentrated - excipient ingredients: water for injections; hydrochloric acid; sodium chloride; arginine; sodium acetate; disodium edetate; polysorbate 80 - 1. previously untreated cll: arzerra is indicated, in combination with chlorambucil or bendamustine, for the treatment of patients with chronic lymphocytic leukaemia (cll) who have not received prior therapy and are inappropriate for fludarabine-based therapy.,2. refractory cll: arzerra, as a single agent, is indicated for the treatment of patients chronic lymphocytic leukaemia (cll) refractory to fludarabine and alemtuzumab.

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

novartis pharmaceuticals uk ltd - ofatumumab - solution for infusion - 20mg/1ml

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

novartis pharmaceuticals uk ltd - ofatumumab - solution for infusion - 20mg/1ml