Europese Unie - Engels - EMA (European Medicines Agency)

novartis europharm limited - nilotinib - leukemia, myelogenous, chronic, bcr-abl positive - antineoplastic agents - tasigna is indicated for the treatment of:adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myelogenous leukaemia (cml) in the chronic phase,paediatric patients with philadelphia chromosome positive cml in chronic phase with resistance or intolerance to prior therapy including imatinib.tasigna is indicated for the treatment of:adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myelogenous leukaemia (cml) in the chronic phase,adult patients with chronic phase and accelerated phase philadelphia chromosome positive cml with resistance or intolerance to prior therapy including imatinib. efficacy data in patients with cml in blast crisis are not available,paediatric patients with chronic phase philadelphia chromosome positive cml with resistance or intolerance to prior therapy including imatinib.

Israël - Engels - 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.

Israël - Engels - Ministry of Health

novartis israel ltd - nilotinib as hydrochloride monohydrate - capsules - nilotinib as hydrochloride monohydrate 150 mg - nilotinib - nilotinib - treatment of adult patients with newly diagnosed philadelphia chromosome positive chronic myelogenous leukemia in chronic phase.

Nieuw-Zeeland - Engels - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - nilotinib hydrochloride monohydrate 165.45mg equivalent to 150 mg nilotinib anhydrous free base;  ;   - capsule - 150 mg - active: nilotinib hydrochloride monohydrate 165.45mg equivalent to 150 mg nilotinib anhydrous free base     excipient: colloidal silicon dioxide crospovidone gelatin iron oxide red iron oxide yellow lactose monohydrate magnesium stearate opacode ink black s-1-277002 poloxamer 188 titanium dioxide - tasigna is indicated for the: · treatment of adult patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukemia (ph+ cml) in chronic phase, · treatment of chronic phase and accelerated phase philadelphia chromosome positive chronic myelogenous leukaemia (cml) in adult patients resistant to or intolerant to at least one prior therapy including imatinib.

Nieuw-Zeeland - Engels - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - nilotinib hydrochloride monohydrate 220.6mg equivalent to 200 mg nilotinib anhydrous free base;   - capsule - 200 mg - active: nilotinib hydrochloride monohydrate 220.6mg equivalent to 200 mg nilotinib anhydrous free base   excipient: colloidal silicon dioxide crospovidone gelatin iron oxide yellow lactose monohydrate magnesium stearate poloxamer 188 tekprint red sw-1102 titanium dioxide - tasigna is indicated for the: · treatment of adult patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+ cml) in chronic phase, · treatment of chronic phase and accelerated phase philadelphia chromosome positive chronic myelogenous leukaemia (cml) in adult patients resistant to or intolerant to at least one prior therapy including imatinib.

Australië - Engels - 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.

Australië - Engels - 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.

Singapore - Engels - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - nilotinib hydrochloride monohydrate 220.6 mg eqv nilotinib anhydrous - capsule - 200mg - nilotinib hydrochloride monohydrate 220.6 mg eqv nilotinib anhydrous 200mg

Singapore - Engels - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - nilotinib hcl monohydrate 165.45mg eqv nilotinib - capsule - 150mg - nilotinib hcl monohydrate 165.45mg eqv nilotinib 150mg

Australië - Engels - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - nilotinib hydrochloride monohydrate; nilotinib -