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

novartis pharmaceuticals australia pty ltd - asciminib hydrochloride, quantity: 43.24 mg (equivalent: asciminib, qty 40 mg) - tablet, film coated - excipient ingredients: polyvinyl alcohol; lactose monohydrate; microcrystalline cellulose; colloidal anhydrous silica; croscarmellose sodium; magnesium stearate; iron oxide black; hyprolose; lecithin; titanium dioxide; iron oxide red; xanthan gum; purified talc - scemblix is indicated for the treatment of patients 18 years of age and above with: ? philadelphia chromosome-positive chronic myeloid leukaemia (ph+ cml) in chronic phase (cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.1 clinical trials). ? ph+ cml in cp with the t315i mutation.

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

novartis pharmaceuticals australia pty ltd - asciminib hydrochloride, quantity: 21.62 mg (equivalent: asciminib, qty 20 mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; magnesium stearate; xanthan gum; titanium dioxide; lactose monohydrate; hyprolose; lecithin; microcrystalline cellulose; iron oxide red; iron oxide yellow; croscarmellose sodium; purified talc; polyvinyl alcohol - scemblix is indicated for the treatment of patients 18 years of age and above with: ? philadelphia chromosome-positive chronic myeloid leukaemia (ph+ cml) in chronic phase (cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.1 clinical trials). ? ph+ cml in cp with the t315i mutation.

European Union - English - EMA (European Medicines Agency)

novartis europharm limited - asciminib hydrochloride - leukemia, myelogenous, chronic, bcr-abl positive - antineoplastic agents - scemblix is indicated for the treatment of adult patients with philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (ph+ cml cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.1).

Canada - English - Health Canada

novartis pharmaceuticals canada inc - asciminib (asciminib hydrochloride) - tablet - 20mg - asciminib (asciminib hydrochloride) 20mg

Canada - English - Health Canada

novartis pharmaceuticals canada inc - asciminib (asciminib hydrochloride) - tablet - 40mg - asciminib (asciminib hydrochloride) 40mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - asciminib hydrochloride - oral tablet - 40mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - asciminib hydrochloride - oral tablet - 20mg

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novartis corporation (malaysia) sdn. bhd. - asciminib hydrochloride -

United States - English - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - asciminib hydrochloride (unii: c5u34s9xfv) (asciminib - unii:l1f3r18w77) - scemblix is indicated for the treatment of adult patients with: - philadelphia chromosome-positive chronic myeloid leukemia (ph+ cml) in chronic phase (cp), previously treated with two or more tyrosine kinase inhibitors (tkis). - ph+ cml in cp with the t315i mutation. none. risk summary based on findings from animal studies and the mechanism of action, scemblix can cause embryo-fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on scemblix use in pregnant women to evaluate a drug-associated risk. animal reproduction studies in pregnant rats and rabbits demonstrated that oral administration of asciminib during organogenesis induced structural abnormalities, embryo-fetal mortality, and alterations to growth (see data ). advise pregnant women and females of reproductive potential of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies i

Israel - English - Ministry of Health

novartis israel ltd - asciminib as hydrochloride - film coated tablets - asciminib as hydrochloride 20 mg - asciminib - scemblix is indicated for the treatment of adult patients with:• philadelphia chromosome-positive chronic myeloid leukemia (ph+ cml) in chronic phase (cp), previously treated with two or more tyrosine kinase inhibitors (tkis).• ph+ cml in cp with the t315i mutation