Izrael - engleski - Ministry of Health

bristol, myers squibb (israel) limited, israel - elotuzumab - powder for concentrate for solution for infusion - elotuzumab 400 mg/vial - elotuzumab - empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.empliciti is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on the last therapy.

Izrael - engleski - Ministry of Health

astrazeneca (israel) ltd - benralizumab - solution for injection - benralizumab 30 mg / 1 ml - benralizumab - fasenra is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.

Izrael - engleski - Ministry of Health

amgen europe b.v. - romosozumab - solution for injection - romosozumab 90 mg / 1 ml - romosozumab - evenity is indicated for the treatment of severe osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

Izrael - engleski - Ministry of Health

novartis israel ltd - brolucizumab - solution for injection - brolucizumab 120 mg / 1 ml - brolucizumab - beovu is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (amd).

Europska Unija - engleski - EMA (European Medicines Agency)

roche registration gmbh - satralizumab - neuromyelitis optica - immunosuppressants - satralizumab (enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.

Izrael - engleski - Ministry of Health

roche pharmaceuticals (israel) ltd - satralizumab - solution for injection - satralizumab 120 mg / 1 ml - satralizumab - enspryng is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

alexion pharmaceuticals australasia pty ltd - ravulizumab, quantity: 100 mg/ml - injection, concentrated - excipient ingredients: monobasic sodium phosphate; dibasic sodium phosphate; polysorbate 80; arginine; sucrose; water for injections - ultomiris is indicated:,? for the treatment of patients with paroxysmal nocturnal haemoglobinuria (pnh),? for the treatment of patients with atypical haemolytic uraemic syndrome (ahus),? as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti-acetylcholine receptor (achr) antibody-positive.,? for the treatment of adult patients with neuromyelitis optica spectrum disorder (nmosd) who are anti-aquaporin 4 (aqp4) antibody-positive.,ultomiris is not intended for the acute treatment of a nmosd relapse.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

alexion pharmaceuticals australasia pty ltd - ravulizumab, quantity: 100 mg/ml - injection, intravenous infusion - excipient ingredients: monobasic sodium phosphate; dibasic sodium phosphate; polysorbate 80; arginine; sucrose; water for injections - ultomiris is indicated:,? for the treatment of patients with paroxysmal nocturnal haemoglobinuria (pnh),? for the treatment of patients with atypical haemolytic uraemic syndrome (ahus),? as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti-acetylcholine receptor (achr) antibody-positive.,? for the treatment of adult patients with neuromyelitis optica spectrum disorder (nmosd) who are anti-aquaporin 4 (aqp4) antibody-positive.,ultomiris is not intended for the acute treatment of a nmosd relapse.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - gemtuzumab ozogamicin, quantity: 5 mg - injection, powder for - excipient ingredients: sucrose; dextran 40; sodium chloride; monobasic sodium phosphate monohydrate; dibasic sodium phosphate - mylotarg is indicated for combination therapy with standard anthracycline and cytarabine (arac) for the treatment of patients age 15 years and above with previously untreated, de novo cd33-positive acute myeloid leukaemia (aml), except acute promyelocytic leukaemia (apl) (see section 4.4 special warnings and precautions for use, and section 5.1 pharmacodynamic properties).

Australija - engleski - Department of Health (Therapeutic Goods Administration)

eli lilly australia pty ltd - galcanezumab, quantity: 120 mg/ml - injection, solution - excipient ingredients: histidine hydrochloride monohydrate; water for injections; histidine; sodium chloride; polysorbate 80 - emgality is indicated for the prophylaxis of migraine in adults.