Israel - English - Ministry of Health

novartis israel ltd - nilotinib as monohydrate - capsules - nilotinib as monohydrate 200 mg - nilotinib - nilotinib - treatment of philadelphia chromosome positive chronic myeloid leukaemia (ph+ cml) in chronic or accelerated phase in patients resistant to or experiencing significant toxicity during treatment with imatinib.treatment of adult patients with newly diagnosed philadelphia chromosome positive chronic myelogenous leukemia in chronic phase.

Israel - English - Ministry of Health

novartis israel ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 100 mg - imatinib - imatinib - glivec is indicated for the treatment of adult patients and children 3 years of age and above with ph+ chronic myeloid leukaemia (ph+ -cml) in chronic phase accelerated phase or blast crisis. glivec is also indicated for the treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist).glivec is also indicated for the treament of : * adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) integrated with chemotherapy.* adult patients with relapsed or refractory ph + all as monotherapy.* adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. * adult patients with myelodyspiastic/myeloproliferative diseases (mds/mpd) associated with pdgfr (platelet - derived growth factor receptor ) gene re- arrangements. * adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) who have the fip1l1- pdgfralfa fusion kinase (mutational analysis or fish demonstration fo chic2 allele deletion) and for patients with hes and/or cel who are fip1l1-pdgfr alfa fusion kinase negative. * adult patients with aggressive systemic mastocytosis (asm) without the d816v c-kit mutation.* adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.

Israel - English - Ministry of Health

novartis israel ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 400 mg - imatinib - imatinib - glivec is indicated for the treatment of adult patients and children 3 years of age and above with ph+ chronic myeloid leukaemia (ph+ -cml) in chronic phase accelerated phase or blast crisis. glivec is also indicated for the treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). glivec is also indicated for the treament of : * adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) integrated with chemotherapy. * adult patients with relapsed or refractory ph + all as monotherapy. * adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. * adult patients with myelodyspiastic/myeloproliferative diseases (mds/mpd) associated with pdgfr (platelet - derived growth factor receptor ) gene re- arrangements. * adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) who have the fip1l1- pdgfralfa fusion kinase (mutational analysis or fish demonstration for chic2 allele deletion) and for patients with hes and/or cel who are fip1l1-pdgfr alfa fusion kinase negative. * adult patients with aggressive systemic mastocytosis (asm) without the d816v c-kit mutation. * adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.

European Union - English - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastic agents - sprycel is indicated for the treatment of paediatric patients with:newly diagnosed philadelphia chromosome-positive chronic myelogenous leukaemia in chronic phase (ph+ cml cp) or ph+ cml cp resistant or intolerant to prior therapy including imatinib.newly diagnosed ph+ acute lymphoblastic leukaemia (all) in combination with chemotherapy.sprycel is indicated for the treatment of adult patients with:newly diagnosed philadelphia-chromosome-positive (ph+) chronic myelogenous leukaemia (cml) in the chronic phase;chronic, accelerated or blast phase cml with resistance or intolerance to prior therapy including imatinib mesilate;ph+ acute lymphoblastic leukaemia (all) and lymphoid blast cml with resistance or intolerance to prior therapy.sprycel is indicated for the treatment of paediatric patients with:newly diagnosed ph+ cml in chronic phase (ph+ cml-cp) or ph+ cml-cp resistant or intolerant to prior therapy including imatinib.

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)

viatris pty ltd - pancreatic extract, quantity: 150 mg (equivalent: amylase, qty 8000 ph eur unit; equivalent: lipase, qty 10000 ph eur unit; equivalent: protease, qty 600 ph eur unit) - capsule, enteric - excipient ingredients: iron oxide yellow; sodium lauryl sulfate; macrogol 4000; iron oxide black; triethyl citrate; titanium dioxide; cetyl alcohol; dimeticone 1000; gelatin; iron oxide red; hypromellose phthalate - creon is indicated as pancreatic enzyme replacement in paediatric and adult patients with pancreatic exocrine insufficiency (pei). pancreatic exocrine insufficiency is often associated with, but not limited to: cystic fibrosis, chronic pancreatitis, pancreatic surgery, gastrointestinal bypass surgery (eg. bilroth ii gastroenterostomy), ductal obstruction of the pancreas or common bile duct (e.g. from neoplasm)

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

viatris pty ltd - pancreatic extract, quantity: 400 mg (equivalent: protease, qty 1600 ph eur unit; equivalent: lipase, qty 40000 ph eur unit; equivalent: amylase, qty 25000 ph eur unit) - capsule, enteric - excipient ingredients: hypromellose phthalate; iron oxide red; titanium dioxide; sodium lauryl sulfate; macrogol 4000; triethyl citrate; iron oxide black; iron oxide yellow; dimeticone 1000; gelatin; cetyl alcohol - creon is indicated as pancreatic enzyme replacement in paediatric and adult patients with pancreatic exocrine insufficiency (pei). pancreatic exocrine insufficiency is often associated with, but not limited to: cystic fibrosis, chronic pancreatitis, pancreatic surgery, gastrointestinal bypass surgery (eg. bilroth ii gastroenterostomy), ductal obstruction of the pancreas or common bile duct (e.g. from neoplasm)

Singapore - English - HSA (Health Sciences Authority)

covidien private limited - gastroenterology & urology - the digitrapper ph-z system is intended to record, store, view, and analyze esophageal and gastric ph data (and optionally, impedance levels) to diagnose reflux disorders.

Singapore - English - HSA (Health Sciences Authority)

radiance medical systems - gastroenterology & urology - the ohmega system is intended to record, store, view and analyse ph, impedance, pressure and various auxiliary input data in the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphincter of oddi, small bowel, colon and anorectal area including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. designated catheters and accessories are required for measurement in each specific area.