Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - fulvestrant (unii: 22x328qoc4) (fulvestrant - unii:22x328qoc4) - fulvestrant 50 mg in 1 ml - monotherapy faslodex is indicated for the treatment of: combination therapy faslodex is indicated for the treatment of: faslodex 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 faslodex [see adverse reactions (6.2)]. risk summary based on findings from animal studies and its mechanism of action, faslodex 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 risk to a fetus. the estimated backg

Ameerika Ühendriigid - inglise - 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

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

bluepoint laboratories - 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, have been re

Iisrael - inglise - Ministry of Health

teva israel ltd - fulvestrant - solution for injection - fulvestrant 50 mg/ml - fulvestrant - monotherapyfulvestrant teva is indicated for the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:* not previously treated with endocrine therapy,or* with disease relapse on or after adjuvant endocrine therapy, or* with disease progression on endocrine therapy.combination therapyfulvestrant teva is indicated for the treatment of:- hr-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in men and postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy.- hr- positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.

Iisrael - inglise - Ministry of Health

novartis israel ltd - fulvestrant - solution for injection - fulvestrant 50 mg/ml - fulvestrant - monotherapyfulvestrant sandoz® is indicated for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:- not previously treated with endocrine therapy, or - with disease relapse on or after adjuvant endocrine therapy; or - disease progression on endocrine therapycombination therapy with palbociclibfulvestrant sandoz® 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.

Euroopa Liit - inglise - EMA (European Medicines Agency)

mylan pharmaceuticals limited - fulvestrant - breast neoplasms - endocrine therapy - fulvestrant is indicated for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:not previously treated with endocrine therapy, orwith disease relapse on or after adjuvant anti-estrogen therapy, or disease progression on antiestrogen therapy.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

interpharma pty ltd - fulvestrant, quantity: 50 mg/ml - injection, solution - excipient ingredients: benzyl alcohol; benzyl benzoate; castor oil; ethanol - fulvestrant ever pharma is indicated for the treatment of postmenopausal women with: ? hormone-receptor (hr) positive, human epidermal growth factor receptor 2(her2) negative, locally advanced or metastatic breast cancer who have not been previously treated with endocrine therapy. ? hr positive, locally advanced or metastatic breast cancer who have progressive disease following prior endocrine (anti-oestrogen or aromatase inhibitor) therapy.

Iirimaa - inglise - HPRA (Health Products Regulatory Authority)

ever valinject gmbh - fulvestrant - solution for injection in pre-filled syringe - 250 milligram(s) - fulvestrant

Malta - inglise - Malta Medicines Authority

teva b.v. swensweg 5, 2031 ga haarlem, netherlands - fulvestrant - solution for injection in a pre-filled syringe - fulvestrant 250 mg - endocrine therapy

Iisrael - inglise - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - fulvestrant - solution for injection - fulvestrant 50 mg/ml - fulvestrant - monotherapy fulvestrant is indicated for the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, or - with disease relapse on or after adjuvant endocrine therapy; or - disease progression on endocrine therapy combination therapy fulvestrant is indicated for the treatment of: - hr-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in men and postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy. - hr-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.