USA - engelsk - 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 - engelsk - 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 - engelsk - 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.

Den europeiske union - dansk - EMA (European Medicines Agency)

novartis europharm limited - ribociclibsuccinat - bryst neoplasmer - antineoplastiske midler - kisqali er indiceret til behandling af kvinder med hormon receptor (hr)‑positiv, human epidermal growth factor receptor 2 (her2)‑negative lokalt fremskreden eller metastatisk brystkræft i kombination med en aromatasehæmmer eller fulvestrant som indledende endokrine-baseret behandling, eller hos kvinder, der har modtaget før den endokrine terapi. i præ‑ eller perimenopausal kvinder, den endokrine behandling bør kombineres med en luteiniserende hormon‑releasing hormon (lhrh) agonist.

Singapore - engelsk - 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 - engelsk - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

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

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

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

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

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

Sveits - italiensk - Swissmedic (Swiss Agency for Therapeutic Products)

novartis pharma schweiz ag - ribociclibum - compresse rivestite con film - ribociclibum 200 mg ut ribociclibi succinas 254.40 mg, cellulosum microcristallinum, hydroxypropylcellulosum substitutum humile, crospovidonum, magnesii stearas, silica colloidalis anhydrica, Überzug: poly(alcohol vinylicus), talcum, lecithinum, xanthani gummi, e 171, e 172, pro compresso obducto. - carcinoma della mammella - synthetika

Canada - fransk - Health Canada

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