Swedish Orphan Biovitrum Pty Ltd - search results

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

empaveli pegcetacoplan 1080 mg/20 ml injection solution vial

swedish orphan biovitrum pty ltd - pegcetacoplan, quantity: 1080 mg - injection, solution - excipient ingredients: water for injections; sodium hydroxide; sodium acetate trihydrate; glacial acetic acid; sorbitol - empaveli is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh) who have an inadequate response to, or are intolerant of, a c5 inhibitor.

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

doptelet avatrombopag (as maleate) 20 mg film-coated tablets blister pack

swedish orphan biovitrum pty ltd - avatrombopag maleate, quantity: 23.6 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; lactose monohydrate; microcrystalline cellulose; magnesium stearate; crospovidone; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - doptelet is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.,doptelet is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (itp) who have had an insufficient response to a previous treatment.

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

kineret anakinra 100mg/0.67ml solution for injection prefilled syringe

swedish orphan biovitrum pty ltd - anakinra, quantity: 100 mg - injection, solution - excipient ingredients: polysorbate 80; sodium citrate dihydrate; water for injections; disodium edetate; sodium chloride - kineret (anakinra) is indicated: -for the treatment of active adult rheumatoid arthritis (ra) in patients who have had inadequate response to one or more other disease modifying anti rheumatic drugs (dmards). kineret should be given in combination with methotrexate. - in adult and paediatric patients aged 8 months and older with a body weight of 10 kg or above for the treatment of cryopyrin-associated periodic syndromes (caps) including neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca), muckle-wells syndrome (mws), and familial cold autoinflammatory syndrome (fcas). - for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 2 years and above who have failed to respond adequately to non-biological dmards

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

orfadin

a menarini australia pty ltd - nitisinone -

European Union - English - EMA (European Medicines Agency)

elocta

swedish orphan biovitrum ab (publ) - efmoroctocog alfa - hemophilia a - antihemorrhagics - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency).