Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - fulvestrant - solution for injection in pre-filled syringe - 250 mg/5ml - anti-estrogens; fulvestrant

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

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

Singapore - English - HSA (Health Sciences Authority)

sandoz singapore pte. ltd. - fulvestrant - injection, solution - fulvestrant 250mg/5ml

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.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - fulvestrant 250 mg/5 ml - solution for injection - 250 mg - fulvestrant 50 mg/ml - fulvestrant

Ireland - English - HPRA (Health Products Regulatory Authority)

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

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.

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - fulvestrant - solution for injection in pre-filled syringe - 250mg millilitre(s) - anti-estrogens; fulvestrant

Canada - English - Health Canada

sandoz canada incorporated - fulvestrant - solution - 50mg - fulvestrant 50mg - antineoplastic agents

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