New Zealand - English - Medsafe (Medicines Safety Authority)

celgene limited - thalidomide 50mg - capsule - 50 mg - active: thalidomide 50mg excipient: gelatin magnesium stearate pregelatinised maize starch - · thalomid in combination with melphalan and prednisone is indicated for the treatment of patients with untreated multiple myeloma aged 65 years or older, 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.

United States - English - NLM (National Library of Medicine)

apopharma usa, inc. - melphalan (unii: q41or9510p) (melphalan - unii:q41or9510p) - melphalan 2 mg - alkeran tablets are indicated for the palliative treatment of multiple myeloma and for the palliation of non-resectable epithelial carcinoma of the ovary. alkeran should not be used in patients whose disease has demonstrated a prior resistance to this agent. patients who have demonstrated hypersensitivity to melphalan should not be given the drug.

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; ethanol; butan-1-ol; isopropyl alcohol; purified water; 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 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 programme.

United States - English - NLM (National Library of Medicine)

acrotech biopharma inc - melphalan hydrochloride (unii: 1vxp4v453t) (melphalan - unii:q41or9510p) - evomela is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. history of serious allergic reaction to melphalan. risk summary based on its mechanism of action, evomela can cause fetal harm when administered to a pregnant woman, including teratogenicity and/or embryo-fetal lethality [see clinical pharmacology (12.1)] . melphalan is a genotoxic drug and can cause chromatid or chromosome damage in humans [see nonclinical toxicology (13.1)] . in animal studies, melphalan was embryolethal and teratogenic in rats at doses below the recommended clinical doses [see data] . advise a pregnant woman of the potential risk to a fetus.. the background risk of major birth defects and miscarriage for the indicated populations are unknown. however, the background risk in the u.s. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. data   animal data adequate ani

United States - English - NLM (National Library of Medicine)

cenexi - bla - melphalan hydrochloride (unii: 1vxp4v453t) (melphalan - unii:q41or9510p) - evomela is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. history of serious allergic reaction to melphalan. risk summary based on its mechanism of action, evomela can cause fetal harm when administered to a pregnant woman, including teratogenicity and/or embryo-fetal lethality [see clinical pharmacology ( 12.1)] . melphalan is a genotoxic drug and can cause chromatid or chromosome damage in humans [see nonclinical toxicology ( 13.1)] . in animal studies, melphalan was embryolethal and teratogenic in rats at doses below the recommended clinical doses [see data] . advise a pregnant woman of the potential risk to a fetus.. the background risk of major birth defects and miscarriage for the indicated populations are unknown. however, the background risk in the u.s. general population of major birth def

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

aspen medical products malaysia sdn bhd - melphalan -

Singapore - English - HSA (Health Sciences Authority)

dksh singapore pte. ltd. - ibandronic acid ( as monosodium monohydrate 56.25mg) - tablet, film coated - 50mg - ibandronic acid ( as monosodium monohydrate 56.25mg) 50mg

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - azathioprine 50mg;   - film coated tablet - 50 mg - active: azathioprine 50mg   excipient: hypromellose lactose monohydrate macrogol 400 magnesium stearate opaspray orange m-1-23104 purified water starch stearic acid - imuran is used as an immunosuppressant antimetabolities, 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 procedured, is indicated to enhance the survival of organ transplants, such as renal transplants, cardiac transplants, and hepatic transplants; and to reduce the corticosteroid requirements of renal transplant recipients. imuran is indicated in the treatment of moderate to severe crohn's disease in patients in whom corticosteroid therapy is required, in patients who cannot tolerate corticosteroid therapy, or in patients whose disease is refractory to other standard first line therapy. imuran, either alone or more usually in combination with corticosteroids and/or other medicines and 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 and polymyositis · auto-immune chronic active hepatitis · permphigus vulgaris · polyarteritis nodosa · auto-immune haemolytic anaemia · chronic refractory idiopathic thrombocytopenic purpura · ulcerative colitis

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - azathioprine 50mg (as freeze-dried sodium salt);   - powder for injection - 50 mg - active: azathioprine 50mg (as freeze-dried sodium salt)   excipient: sodium hydroxide - imuran is used as an immunosuppressant antimetabolities, 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 procedured, is indicated to enhance the survival of organ transplants, such as renal transplants, cardiac transplants, and hepatic transplants; and to reduce the corticosteroid requirements of renal transplant recipients. imuran is indicated in the treatment of moderate to severe crohn's disease in patients in whom corticosteroid therapy is required, in patients who cannot tolerate corticosteroid therapy, or in patients whose disease is refractory to other standard first line therapy. imuran, either alone or more usually in combination with corticosteroids and/or other medicines and 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 and polymyositis · auto-immune chronic active hepatitis · permphigus vulgaris · polyarteritis nodosa · auto-immune haemolytic anaemia · chronic refractory idiopathic thrombocytopenic purpura · ulcerative colitis

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - ciclosporin 50mg;   - soft gelatin capsule - 50 mg - active: ciclosporin 50mg   excipient: corn oil dl-alpha tocopherol ethanol gelatin glycerol polyethylene glycol hydrogenated castor oil propylene glycol   titanium dioxide - solid organ transplantation prevention of graft rejection following kidney, liver, heart, combined heart-lung, lung or pancreas allogeneic transplantations. treatment of transplant rejection in patients previously receiving other immunosuppressive agents. bone marrow transplantation prevention of graft rejection following bone marrow transplantation. prevention or treatment of graft-versus-host disease (gvhd).