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

novartis pharmaceuticals corporation - ribociclib succinate (unii: bg7hlx2919) (ribociclib - unii:tk8ere8p56) - ribociclib 200 mg - kisqali is indicated for the treatment of adult patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with: - an aromatase inhibitor as initial endocrine-based therapy; or - fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men. none. risk summary based on findings from animal studies and the mechanism of action, kisqali can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available human data informing the drug-associated risk. in animal reproduction studies, administration of ribociclib to pregnant animals during organogenesis resulted in increased incidences of post implantation loss and reduced fetal weights in rats and increased incidences of fetal abnormalities in rabbits at exposures 0.6 or 1.5 times the exposure in humans, respectively, at the highest recommended dose

Israel - English - Ministry of Health

novartis israel ltd - ribociclib as succinate - film coated tablets - ribociclib as succinate 200 mg - ribociclib - kisqali is indicated in combination with:* a non-steroid aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women, with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative locally advanced or metastatic breast cancer, as initial endocrine-based therapy.or* fulvestrant for the treatment of men and postmenopausal women with hr-positive, her2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.

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

novartis pharmaceuticals australia pty ltd - ribociclib succinate, quantity: 254.4 mg (equivalent: ribociclib, qty 200 mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; hyprolose; crospovidone; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin; iron oxide black; iron oxide red - kisqali is indicated for the treatment of patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer, in combination with an aromatase inhibitor or fulvestrant, as initial endocrine-based therapy or following prior endocrine therapy.

Singapore - English - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - ribociclib succinate 254.4mg eqv ribociclib - tablet, film coated - ribociclib succinate 254.4mg eqv ribociclib 200mg

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

novartis pharma produktions gmbh - ribociclib(ribociclib succinate) - tablets film-coated - 200mg

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

novartis pharma stein ag - ribociclib (ribociclib succinate) - tablets film-coated - 200mg

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

novartis pharma produktions gmbh - ribociclib(ribociclib succinate) - tablets film-coated - 200mg

Canada - English - Health Canada

novartis pharmaceuticals canada inc - ribociclib (ribociclib succinate) - tablet - 200mg - ribociclib (ribociclib succinate) 200mg - antineoplastic agents

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

novartis pharma ag - ribociclib (como succinato de ribociclib) - ribociclib (como succinato de ribociclib)....200.00 mg

European Union - English - EMA (European Medicines Agency)

novartis europharm limited - ribociclib succinate - breast neoplasms - antineoplastic agents - kisqali is indicated for the treatment of women with hormone receptor (hr)‑positive, human epidermal growth factor receptor 2 (her2)‑negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.in pre‑ or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone‑releasing hormone (lhrh) agonist.