Unia Europejska - angielski - EMA (European Medicines Agency)

oncopeptides ab - melphalan flufenamide hydrochloride - multiple myeloma - antineoplastic agents - pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-cd38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. for patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation (see section 4.4).

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

atnahs pharma australia pty ltd - ibandronate sodium, quantity: 56.25 mg (equivalent: ibandronic acid, qty 50 mg) - tablet, film coated - excipient ingredients: povidone; crospovidone; stearic acid; hypromellose; colloidal anhydrous silica; purified talc; macrogol 6000; lactose monohydrate; microcrystalline cellulose; titanium dioxide - the treatment of metastatic bone disease in patients with breast cancer.

Wielka Brytania - angielski - MHRA (Medicines & Healthcare Products Regulatory Agency)

viatris uk healthcare ltd - ciclosporin - oral capsule - 50mg

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

aspen pharmacare australia pty ltd - azathioprine, quantity: 50 mg - injection, powder for - excipient ingredients: sodium hydroxide - indications as at 11 february 2005: imuran is used as an immunosuppressant antimetabolite either alone, or more commonly, in combination with other agents (usually corticosteroids) and procedures which influence the immune response. therapeutic effect may be evident only after weeks or months and can include a steroid-sparing effect, thereby reducing the toxicity associated with high dosage and prolonged usage of corticosteroids. imuran, in combination with corticosteroids and/or other immunosuppressive agents and procedures, is indicated in the management of patients receiving organ transplants. imuran, either alone or more usually in combination with corticosteroids and/or other procedures, has been used with clinical benefit which may include reduction of dosage or discontinuation of corticosteroids, in a proportion of patients suffering form the following: severe rheumatoid arthritis; systemic lupus erythematosus; dermatomyositis/polymyositis; autoimmune chronic active hepatitis; pemphigus vulgaris; polya

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

sandoz pty ltd - azathioprine, quantity: 50 mg - tablet, film coated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; titanium dioxide; lactose monohydrate; maize starch; purified talc; povidone; hypromellose; microcrystalline cellulose; peg-8 stearate - immunosuppressant antimetabolite: either alone, or more commonly, in combination with other agents (usually corticosteroids) and procedures which influence the immune response. therapeutic effect may be evident only after weeks or months and can include a steroid-sparing effect, thereby reducing the toxicity associated with high dosage and prolonged usage of corticosteroids. azathioprine, in combination with corticosteroids and/or other immunosuppressive agents and procedures, is indicated in the management of patients receiving organ transplants. azathioprine, either alone or more usually in combination with corticosteroids and/or other procedures, has been used with clinical benefit which may include reduction of dosage or discontinuation of corticosteroids, in a proportion of patients suffering from the following: severe rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis/polymyositis, autoimmune chronic active hepatitis, pemphigus vulgaris, polyarteritis nodosa, autoimmune haemolytic anaemia, chronic refractory idiopathic thrombocytopenic purpura.

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

arrotex pharmaceuticals pty ltd - azathioprine, quantity: 50 mg - tablet - excipient ingredients: lactose monohydrate; magnesium stearate; maize starch; microcrystalline cellulose; macrogol 8000; hypromellose; macrogol 400 - azathioprine is used as an immunosuppressant anti-metabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and procedures which influence the immune response. therapeutic effects may be evident only after weeks or months and can include a steroid-sparing effect, thereby reducing the toxicity associated with high dosage and prolonged usage of corticosteroids.,azathioprine, in combination with corticosteroids and/or other immunosuppressive agents and procedures, is indicated in the management of patients receiving organ transplants.,azathioprine, either alone or more usually in combination with corticosteroids and/or other procedures, has been used with clinical benefit which may include reduction of dosage or discontinuation of corticosteroids, in a proportion of patients suffering from the following: ,? severe rheumatoid arthritis;,? systemic lupus erythematosus;,? dermatomyositis / polymyositis;,? autoimmune chronic active hepatitis;,? pemphigus vulgaris;,? polyarteritis nodosa;,? autoimmune haemolytic anaemia; ,? chronic refractory idiopathic thrombocytopenic purpura.

Kanada - angielski - Health Canada

aspen pharmacare canada inc. - melphalan - tablet - 2mg - melphalan 2mg - antineoplastic agents

Kanada - angielski - Health Canada

baxter corporation - cyclophosphamide - tablet - 50mg - cyclophosphamide 50mg - antineoplastic agents

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

celgene pty ltd - thalidomide, quantity: 150 mg - capsule, hard - excipient ingredients: magnesium stearate; pregelatinised maize starch; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; ethanol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; titanium dioxide; sorbitan monolaurate; caramel; potable water; gelatin; sodium lauryl sulfate; pharmaceutical glaze; dimeticone - multiple myeloma - thalomid in combination with melphalan and prednisone is indicated for the treatment of patients with untreated multiple myeloma aged 65 years and over or ineligible for high dose chemotherapy. thalomid in combination with dexamethasone is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue, for the treatment of patients with untreated multiple myeloma. thalomid, as monotherapy, is indicated for the treatment of multiple myeloma after failure of standard therapies. erythema nodosum leprosum (enl). thalomid is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (enl). thalomid is not indicated as monotherapy for such enl treatment in the presence of moderate to severe neuritis. thalomid is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of enl recurrence. multiple myeloma - thalomid in combination with melphalan and prednisone is indi

Wielka Brytania - angielski - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - ciclosporin - oral capsule - 50mg