Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

zaphyr pharmaceuticals ireland limited, ireland - imatinib mesilate - capsule, hard - 400 mg

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

adel ahmed al-shaeir pharmaceutical company, saudi arabia - imatinib mesilate - capsule, hard - 100 mg

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

adel ahmed al-shaeir pharmaceutical company, saudi arabia - imatinib mesilate - capsule, hard - 400 mg

Ireland - English - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - imatinib mesylate - film-coated tablet - 400 milligram(s) - other antineoplastic agents - antineoplastic agents, protein kinase inhibitor - imatinib actavis group is indicated for the treatment of - paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. - paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult patients with ph+ cml in blast crisis. - adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. - adult patients with relapsed or refractory ph+ all as monotherapy. - adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. - adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr
rearrangement.

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

novartis pharmaceuticals australia pty ltd - nilotinib hydrochloride monohydrate, quantity: 165.45 mg (equivalent: nilotinib, qty 150 mg) - capsule, hard - excipient ingredients: magnesium stearate; gelatin; titanium dioxide; lactose monohydrate; colloidal anhydrous silica; poloxamer; iron oxide yellow; crospovidone; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid; industrial methylated spirit; ammonia - tasigna is indicated for the:,? treatment of adult patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (cml) in chronic phase. ? treatment of adults with chronic phase and accelerated phase philadelphia chromosome positive chronic myeloid leukaemia (cml) resistant to or intolerant of prior therapy including imatinib.

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

novartis pharmaceuticals australia pty ltd - nilotinib hydrochloride monohydrate, quantity: 220.6 mg (equivalent: nilotinib, qty 200 mg) - capsule, hard - excipient ingredients: magnesium stearate; crospovidone; titanium dioxide; iron oxide yellow; poloxamer; gelatin; lactose monohydrate; colloidal anhydrous silica; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; iron oxide red; ethanol absolute; potassium hydroxide; ammonia; industrial methylated spirit; iron oxide black; sulfuric acid; lecithin; xanthan gum; benzoic acid; sorbic acid; methylcellulose; polyethylene glycol; silica dimethicone silylate; dimeticone - tasigna is indicated for the:,? treatment of adult patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (cml) in chronic phase. ? treatment of adults with chronic phase and accelerated phase philadelphia chromosome positive chronic myeloid leukaemia (cml) resistant to or intolerant of prior therapy including imatinib.

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

arrotex pharmaceuticals pty ltd - sunitinib malate, quantity: 66.825 mg (equivalent: sunitinib, qty mg) - capsule, hard - excipient ingredients: gelatin; mannitol; magnesium stearate; titanium dioxide; purified water; croscarmellose sodium; povidone; iron oxide black; iron oxide yellow; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia; potassium hydroxide - arx-sunitinib is indicated for:,? treatment of advanced renal cell carcinoma (rcc),? treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance,? treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net).

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

arrotex pharmaceuticals pty ltd - sunitinib malate, quantity: 50.119 mg (equivalent: sunitinib, qty mg) - capsule, hard - excipient ingredients: gelatin; mannitol; magnesium stearate; titanium dioxide; purified water; croscarmellose sodium; povidone; iron oxide yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - arx-sunitinib is indicated for:,? treatment of advanced renal cell carcinoma (rcc),? treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance,? treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net).

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

arrotex pharmaceuticals pty ltd - sunitinib malate, quantity: 33.413 mg (equivalent: sunitinib, qty 25 mg) - capsule, hard - excipient ingredients: gelatin; mannitol; magnesium stearate; iron oxide red; titanium dioxide; purified water; croscarmellose sodium; povidone; iron oxide yellow; iron oxide black; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia; potassium hydroxide - arx-sunitinib is indicated for:,? treatment of advanced renal cell carcinoma (rcc),? treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance,? treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net).

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

arrotex pharmaceuticals pty ltd - sunitinib malate, quantity: 16.706 mg (equivalent: sunitinib, qty 12.5 mg) - capsule, hard - excipient ingredients: gelatin; mannitol; magnesium stearate; iron oxide red; titanium dioxide; purified water; croscarmellose sodium; povidone; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia; potassium hydroxide - arx-sunitinib is indicated for:,? treatment of advanced renal cell carcinoma (rcc),? treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance,? treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net).