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

alembic pharmaceuticals inc. - fulvestrant (unii: 22x328qoc4) (fulvestrant - unii:22x328qoc4) - monotherapy fulvestrant injection is indicated for the treatment of: - hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or - hr-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. combination therapy fulvestrant injection is indicated for the treatment of: - hr-positive, her2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy. - hr-positive, her2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. fulvestrant is contraindicated in patients with a known hypersensitivity to the drug or to any of its components. hypersensitivity reactions, including urticaria and angioedema

Canada - English - Health Canada

auro pharma inc - fulvestrant - solution - 50mg - fulvestrant 50mg

Canada - English - Health Canada

formative pharma inc. - fulvestrant - solution - 50mg - fulvestrant 50mg

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

sandoz inc - fulvestrant (unii: 22x328qoc4) (fulvestrant - unii:22x328qoc4) - monotherapy fulvestrant injection is indicated for the treatment of: combination therapy fulvestrant injection is indicated for the treatment of: fulvestrant is contraindicated in patients with a known hypersensitivity to the drug or to any of its components. hypersensitivity reactions, including urticaria and angioedema, have been reported in association with fulvestrant [see adverse reactions (6.2) ]. risk summary based on findings from animal studies and its mechanism of action, fulvestrant 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 fulvestrant to pregnant rats and rabbits during organogenesis caused embryo-fetal toxicity, including skeletal malformations and fetal loss, at daily doses that were 6% and 30% of the maximum recommended human dose based on mg/m2 , respectively [see data ]. advise pregnant women of the potential

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

eugia us llc - fulvestrant (unii: 22x328qoc4) (fulvestrant - unii:22x328qoc4) - monotherapy fulvestrant injection is indicated for the treatment of: - hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or - hr-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. combination therapy fulvestrant injection is indicated for the treatment of: - hr-positive, her2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy. - hr-positive, her2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. fulvestrant is contraindicated in patients with a known hypersensitivity to the drug or to any of its components. hypersensitivity reactions, including urticaria and angioe

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

ever pharma jena gmbh - fulvestrant - solution for injection - 250mg/5ml

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - fulvestrant 50 mg/ml;  ;   - solution for injection - 250 mg/5ml - active: fulvestrant 50 mg/ml     excipient: benzyl alcohol benzyl benzoate castor oil ethanol - fulvestrant ever pharma is indicated for the treatment of locally advanced or metastatic breast cancer in postmenopausal women of any age: · previously treated with endocrine therapy (antioestrogen or aromatase inhibitor) therapy, irrespective of whether their postmenopausal status occurred naturally or was artificially induced.

New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - fulvestrant 50 mg/ml - solution for injection - 250 mg/5ml - active: fulvestrant 50 mg/ml excipient: benzyl alcohol benzyl benzoate castor oil ethanol - fulvestrant-aft is indicated for the treatment of locally advanced or metastatic breast cancer in postmenopausal women of any age previously treated with endocrine therapy (antioestrogen or aromatase inhibitor), irrespective of whether their postmenopausal status occurred naturally or was artificially induced.

Israel - English - Ministry of Health

astra zeneca (israel) ltd - fulvestrant - solution for injection - fulvestrant 250 mg / 5 ml - fulvestrant - fulvestrant - monotherapy :faslodex is indicated for the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, orwith disease relapse on or after adjuvant endocrine therapy; or disease progression on endocrine therapy.combination therapy with palbociclib: faslodex is indicated for the treatment of hr-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with palbociclib in women with disease progression after endocrine therapy

Israel - English - Ministry of Health

astra zeneca (israel) ltd - fulvestrant - solution for injection - fulvestrant 250 mg / 5 ml - fulvestrant - fulvestrant - monotherapy :faslodex is indicated for the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, orwith disease relapse on or after adjuvant endocrine therapy; or disease progression on endocrine therapy.combination therapy with palbociclib: faslodex is indicated for the treatment of hr-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with palbociclib in women with disease progression after endocrine therapy