Israel - English - 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.

Israel - English - 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.

European Union - English - 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.

Australia - English - 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

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

Malta - English - 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

Israel - English - 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.

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

accord healthcare pty ltd - fulvestrant, quantity: 250 mg - injection, solution - excipient ingredients: benzyl alcohol; castor oil; benzyl benzoate; ethanol - fulvestrant accord 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

reddy holding gmbh - fulvestrant - solution for injection in pre-filled syringe - fulvestrant

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

aft pharmaceuticals pty ltd - fulvestrant, quantity: 250 mg - injection, solution - excipient ingredients: ethanol; benzyl alcohol; benzyl benzoate; castor oil - fulvestrant-aft 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.