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

bayer healthcare pharmaceuticals inc. - copanlisib (unii: wi6v529fz9) (copanlisib - unii:wi6v529fz9) - copanlisib 15 mg in 1 ml - aliqopa is indicated for the treatment of adult patients with relapsed follicular lymphoma (fl) who have received at least two prior systemic therapies. none. based on findings from animal studies and the mechanism of action, aliqopa can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data in pregnant women to inform the drug-associated risk. in animal reproduction studies, administration of copanlisib to pregnant rats during organogenesis resulted in embryo-fetal death and fetal abnormalities at maternal doses approximately 12% of the recommended dose for patients (see data) . advise pregnant women of the potential risk to a fetus. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. the background risk of major birth defects and miscarriage for the indicated population are unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinicall

Israel - English - Ministry of Health

bayer israel ltd - copanlisib as dihydrochloride - powder for concentrated solution for infusion - copanlisib as dihydrochloride 60 mg/vial - copanlisib - aliqopa is indicated for the treatment of adult patients with relapsed follicular lymphoma (fl) who have received at least two prior systemic therapies.

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

novartis pharmaceuticals australia pty ltd - alpelisib, quantity: 200 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; mannitol; sodium starch glycollate; hypromellose; magnesium stearate; purified talc; macrogol 4000; iron oxide black; iron oxide red; titanium dioxide - piqray in combination with fulvestrant, is indicated for the treatment of postmenopausal women, and men, with hormone receptor positive, her2-negative, advanced or metastatic breast cancer with a pik3ca mutation as detected by a validated test following progression on or after an endocrine-based regimen

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

novartis pharmaceuticals australia pty ltd - alpelisib, quantity: 200 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; mannitol; sodium starch glycollate; hypromellose; magnesium stearate; purified talc; macrogol 4000; iron oxide black; iron oxide red; titanium dioxide - piqray in combination with fulvestrant, is indicated for the treatment of postmenopausal women, and men, with hormone receptor positive, her2-negative, advanced or metastatic breast cancer with a pik3ca mutation as detected by a validated test following progression on or after an endocrine-based regimen

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

novartis pharmaceuticals australia pty ltd - alpelisib, quantity: 150 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; mannitol; sodium starch glycollate; hypromellose; magnesium stearate; purified talc; macrogol 4000; iron oxide black; iron oxide red; titanium dioxide - piqray in combination with fulvestrant, is indicated for the treatment of postmenopausal women, and men, with hormone receptor positive, her2-negative, advanced or metastatic breast cancer with a pik3ca mutation as detected by a validated test following progression on or after an endocrine-based regimen

Israel - English - Ministry of Health

novartis israel ltd - alpelisib - film coated tablets - alpelisib 150 mg - alpelisib - piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative, pik3camutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen

Israel - English - Ministry of Health

novartis israel ltd - alpelisib - film coated tablets - alpelisib 200 mg - alpelisib - piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative, pik3camutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen

Israel - English - Ministry of Health

novartis israel ltd - alpelisib - film coated tablets - alpelisib 50 mg - alpelisib - piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative, pik3camutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen

European Union - English - EMA (European Medicines Agency)

novartis europharm limited  - alpelisib - breast neoplasms - antineoplastic agents - piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative, locally advanced or metastatic breast cancer with a pik3ca mutation after disease progression following endocrine therapy as monotherapy (see section 5.1).

Canada - English - Health Canada

novartis pharmaceuticals canada inc - alpelisib - tablet - 50mg - alpelisib 50mg - antineoplastic agents