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)

cipla australia pty ltd - erlotinib hydrochloride, quantity: 109.267 mg (equivalent: erlotinib, qty 100 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; sodium starch glycollate type a; magnesium stearate; sodium lauryl sulfate; titanium dioxide; hypromellose; hyprolose; macrogol 400 - non-small cell lung cancer erlotinib cipla is indicated for the first-line treatment of patients with advanced (stage iiib) or metasttic (stega iv) non-small cell lung cancer (nsclc) with activating egfr mutations. erlotinib cipla is indicated for matintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfr mutations who have not progressed on first-line chemotherapy. erlotinib cipla is also indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer after failure of prior chemotherapy.,pancreatic cancer erlotinib cipla in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

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

cipla australia pty ltd - erlotinib hydrochloride, quantity: 163.9 mg (equivalent: erlotinib, qty 150 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; sodium starch glycollate type a; magnesium stearate; sodium lauryl sulfate; titanium dioxide; hypromellose; hyprolose; macrogol 400 - non-small cell lung cancer erlotinib cipla is indicated for the first-line treatment of patients with advanced (stage iiib) or metasttic (stega iv) non-small cell lung cancer (nsclc) with activating egfr mutations. erlotinib cipla is indicated for matintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfr mutations who have not progressed on first-line chemotherapy. erlotinib cipla is also indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer after failure of prior chemotherapy.,pancreatic cancer erlotinib cipla in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

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

cipla australia pty ltd - erlotinib hydrochloride, quantity: 27.317 mg (equivalent: erlotinib, qty 25 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; sodium starch glycollate type a; magnesium stearate; sodium lauryl sulfate; titanium dioxide; hypromellose; hyprolose; macrogol 400 - non-small cell lung cancer erlotinib cipla is indicated for the first-line treatment of patients with advanced (stage iiib) or metasttic (stega iv) non-small cell lung cancer (nsclc) with activating egfr mutations. erlotinib cipla is indicated for matintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfr mutations who have not progressed on first-line chemotherapy. erlotinib cipla is also indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer after failure of prior chemotherapy.,pancreatic cancer erlotinib cipla in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

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

cipla australia pty ltd - fluticasone propionate, quantity: 250 microgram/actuation - inhalation, pressurised - excipient ingredients: norflurane - for use in the prophylactic management of asthma in adults and adolescents over 16 years of age.

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

cipla australia pty ltd - fluticasone propionate, quantity: 125 microgram/actuation - inhalation, pressurised - excipient ingredients: norflurane - for use in the prophylactic management of asthma in adults and adolescents over 16 years of age.

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

cipla australia pty ltd - imatinib mesilate, quantity: 119.5 mg (equivalent: imatinib, qty 100 mg) - capsule - excipient ingredients: colloidal anhydrous silica; lactose; magnesium stearate; crospovidone; titanium dioxide; purified water; iron oxide yellow; iron oxide red; gelatin; sodium lauryl sulfate - ? treatment of patients with chronic myeloid leukaemia (cml) ? treatment of adult 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).

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

cipla australia pty ltd - imatinib mesilate, quantity: 478 mg (equivalent: imatinib, qty 400 mg) - capsule - excipient ingredients: magnesium stearate; lactose; colloidal anhydrous silica; crospovidone; titanium dioxide; purified water; iron oxide yellow; iron oxide red; gelatin; sodium lauryl sulfate - ? treatment of patients with chronic myeloid leukaemia (cml) ? treatment of adult 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).

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

cipla australia pty ltd - salmeterol xinafoate, quantity: 36.32 microgram/actuation (equivalent: salmeterol, qty 25 microgram/actuation); fluticasone propionate, quantity: 250 microgram/actuation - inhalation, pressurised - excipient ingredients: norflurane - for the regular treatment of asthma, where the use of a combination product is appropriate. this may include: - patients on effective maintenance doses of long-acting beta-2 agonists and inhaled corticosteroids. - patients who are symptomatic on current inhaled corticosteroid therapy.,for the symptomatic treatment of patients with severe copd (fev1 less than 50 precent predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. fluticasone propionate/salmeterol (125 microgram/25 microgram and 250 microgram/25 microgram) is not indicated for the initiation of bronchodilator therapy in copd.

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

cipla australia pty ltd - salmeterol xinafoate, quantity: 36.32 microgram/actuation (equivalent: salmeterol, qty 25 microgram/actuation); fluticasone propionate, quantity: 125 microgram/actuation - inhalation, pressurised - excipient ingredients: norflurane - for the regular treatment of asthma, where the use of a combination product is appropriate. this may include: - patients on effective maintenance doses of long-acting beta-2 agonists and inhaled corticosteroids. - patients who are symptomatic on current inhaled corticosteroid therapy.,for the symptomatic treatment of patients with severe copd (fev1 less than 50 precent predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. fluticasone propionate/salmeterol (125 microgram/25 microgram and 250 microgram/25 microgram) is not indicated for the initiation of bronchodilator therapy in copd.