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

celgene pty ltd - romidepsin, quantity: 10 mg - injection, powder for - excipient ingredients: povidone; dilute hydrochloric acid - istodax is indicated for the treatment of peripheral t-cell lymphoma in patients who have received at least one prior systemic therapy.

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

celgene pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - a)intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), b)chronic myelomonocytic leukemia (cmmol 10%-29% marrow blasts without myeloproliferative disorder)), c) acute myeloid leukemia (aml) with 20-30% blasts and multi-lineage dysplasia, according to world health organisation classification (who). in whom allogenic stem cell transplantation is not indicated.

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

celgene pty ltd - azacitidine -

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

celgene pty ltd - thalidomide, quantity: 100 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; gelatin; sodium lauryl sulfate - 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. thalomid is prescribed and dispensed through the thalidomide risk management pro

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

celgene pty ltd - thalidomide, quantity: 50 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; gelatin - 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

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

celgene pty ltd - lenalidomide, quantity: 20 mg - capsule, hard - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate; lactose; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - multiple myeloma (mm) revlimid is indicated for treatment of multiple myeloma.,myelodysplastic syndromes (mds) revlimid is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.,mantle cell lymphoma (mcl) revlimid is indicated for the treatment of patients with relapsed and/or refractory mantle cell lymphoma.

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

celgene pty ltd - lenalidomide, quantity: 7.5 mg - capsule, hard - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate; lactose; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - multiple myeloma (mm) revlimid is indicated for treatment of multiple myeloma.,myelodysplastic syndromes (mds) revlimid is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.,mantle cell lymphoma (mcl) revlimid is indicated for the treatment of patients with relapsed and/or refractory mantle cell lymphoma.

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

celgene pty ltd - lenalidomide, quantity: 2.5 mg - capsule, hard - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate; lactose; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - multiple myeloma (mm) revlimid is indicated for treatment of multiple myeloma.,myelodysplastic syndromes (mds) revlimid is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.,mantle cell lymphoma (mcl) revlimid is indicated for the treatment of patients with relapsed and/or refractory mantle cell lymphoma.

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

celgene pty ltd - pomalidomide, quantity: 1 mg - capsule - excipient ingredients: sodium stearylfumarate; mannitol; pregelatinised maize starch; titanium dioxide; indigo carmine; iron oxide yellow; shellac; simethicone; propylene glycol; strong ammonia solution; isopropyl alcohol; butan-1-ol; ethanol absolute; iron oxide black; gelatin - pomalyst, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including lenalidomide. pomalyst, in combination with dexamethasone, is indicated for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

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

celgene pty ltd - pomalidomide, quantity: 3 mg - capsule - excipient ingredients: pregelatinised maize starch; mannitol; sodium stearylfumarate; iron oxide black; shellac; propylene glycol; strong ammonia solution; ethanol absolute; purified water; butan-1-ol; isopropyl alcohol; indigo carmine; iron oxide yellow; titanium dioxide; gelatin - pomalyst, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including lenalidomide. pomalyst, in combination with dexamethasone, is indicated for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.