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

arrotex pharmaceuticals pty ltd - lansoprazole, quantity: 30 mg - capsule - excipient ingredients: gelatin; hypromellose; sucrose; purified talc; macrogol 300; indigo carmine; maize starch; carmoisine; methacrylic acid - ethyl acrylate copolymer (1:1); colloidal anhydrous silica; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid - adults:. apo-lansoprazole capsules are indicated for. - healing and long-term management of reflux oesophagitis. . - healing and long-term management for patients with duodenal ulcer.. - healing of benign gastric ulcer. patients whose gastric or duodenal ulcer is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. . - patients with benign peptic lesions that do not respond to h2-receptor antagonists.. - eradication of h. pylori from the upper gastrointestinal tract in patients with peptic ulcer or chronic gastritis when used in combination with appropriate antibiotics. . - relief of reflux-like and/or ulcer-like symptoms associated with acid-related dyspepsia. . paediatric and adolescent patients i to 17 years of age:. apo-lansoprazole capsules are indicated for. - treatment of gastro-oesophageal reflux disease, including all grades of oesophagitis. . - healing of erosive oesophagitis.

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

cipla australia pty ltd - lenalidomide, quantity: 25 mg - capsule - excipient ingredients: lactose; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; sorbitan monolaurate; potable water; gelatin; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; shellac glaze-45% (20% esterified) in ethanol - multiple myeloma (mm) lenalidomide is indicated for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation. lenalidomide is indicated for the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide in combination with dexamethasone is indicated for the treatment of multiple myeloma patients whose disease has progressed after one therapy.,myelodysplastic syndromes (mds) lenalidomide 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.

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

cipla australia pty ltd - lenalidomide, quantity: 20 mg - capsule - excipient ingredients: lactose; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; sorbitan monolaurate; potable water; gelatin; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; shellac glaze-45% (20% esterified) in ethanol - multiple myeloma (mm) lenalidomide is indicated for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation. lenalidomide is indicated for the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide in combination with dexamethasone is indicated for the treatment of multiple myeloma patients whose disease has progressed after one therapy.,myelodysplastic syndromes (mds) lenalidomide 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.

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

cipla australia pty ltd - lenalidomide, quantity: 15 mg - capsule - excipient ingredients: lactose; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; sorbitan monolaurate; potable water; gelatin; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; shellac glaze-45% (20% esterified) in ethanol - multiple myeloma (mm) lenalidomide is indicated for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation. lenalidomide is indicated for the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide in combination with dexamethasone is indicated for the treatment of multiple myeloma patients whose disease has progressed after one therapy.,myelodysplastic syndromes (mds) lenalidomide 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.

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

cipla australia pty ltd - lenalidomide, quantity: 10 mg - capsule - excipient ingredients: lactose; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; sorbitan monolaurate; potable water; gelatin; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; shellac glaze-45% (20% esterified) in ethanol - multiple myeloma (mm) lenalidomide is indicated for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation. lenalidomide is indicated for the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide in combination with dexamethasone is indicated for the treatment of multiple myeloma patients whose disease has progressed after one therapy.,myelodysplastic syndromes (mds) lenalidomide 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.

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

cipla australia pty ltd - lenalidomide, quantity: 5 mg - capsule - excipient ingredients: lactose; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; sorbitan monolaurate; potable water; gelatin; sodium lauryl sulfate - multiple myeloma (mm) lenalidomide is indicated for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation. lenalidomide is indicated for the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide in combination with dexamethasone is indicated for the treatment of multiple myeloma patients whose disease has progressed after one therapy.,myelodysplastic syndromes (mds) lenalidomide 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.

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

avallon pharmaceuticals pty ltd - lansoprazole, quantity: 30 mg - capsule - excipient ingredients: methacrylic acid - ethyl acrylate copolymer (1:1); hypromellose; indigo carmine; colloidal anhydrous silica; titanium dioxide; maize starch; purified talc; macrogol 300; sucrose; carmoisine; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid - adults:. lanzopran capsules are indicated for. - healing and long-term management of reflux oesophagitis. . - healing and long-term management for patients with duodenal ulcer.. - healing of benign gastric ulcer. patients whose gastric or duodenal ulcer is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. . - patients with benign peptic lesions that do not respond to h2-receptor antagonists.. - eradication of h. pylori from the upper gastrointestinal tract in patients with peptic ulcer or chronic gastritis when used in combination with appropriate antibiotics. . - relief of reflux-like and/or ulcer-like symptoms associated with acid-related dyspepsia. . paediatric and adolescent patients i to 17 years of age:. lanzopran capsules are indicated for. - treatment of gastro-oesophageal reflux disease, including all grades of oesophagitis. . - healing of erosive oesophagitis.

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

arrotex pharmaceuticals pty ltd - dimethyl fumarate, quantity: 240 mg - capsule, enteric - excipient ingredients: croscarmellose sodium; gelatin; purified talc; magnesium stearate; iron oxide yellow; silicified microcrystalline cellulose; triethyl citrate; titanium dioxide; brilliant blue fcf; methacrylic acid copolymer; colloidal anhydrous silica; iron oxide black; methacrylic acid - ethyl acrylate copolymer (1:1); propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; potassium hydroxide - dimethyl fumarate enteric coated capsules are indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

arrotex pharmaceuticals pty ltd - dimethyl fumarate, quantity: 120 mg - capsule, enteric - excipient ingredients: croscarmellose sodium; gelatin; purified talc; magnesium stearate; iron oxide yellow; silicified microcrystalline cellulose; triethyl citrate; titanium dioxide; brilliant blue fcf; methacrylic acid copolymer; colloidal anhydrous silica; iron oxide black; methacrylic acid - ethyl acrylate copolymer (1:1); propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; potassium hydroxide - dimethyl fumarate enteric coated capsules are indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

dr reddys laboratories australia pty ltd - imatinib mesilate, quantity: 119.47 mg (equivalent: imatinib, qty 100 mg) - capsule, hard - excipient ingredients: crospovidone; sodium stearylfumarate; gelatin; titanium dioxide; purified water; iron oxide yellow; sodium lauryl sulfate; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia - indicated for the: ,? treatment of patients with chronic myeloid leukaemia (cml) ,? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ,? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ,? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ,? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ,? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp). ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials)