Sør-Afrika - engelsk - South African Health Products Regulatory Authority (SAHPRA)

cipla medpro (pty) ltd - capsules - 75,0 mg - palbociclib

Sør-Afrika - engelsk - South African Health Products Regulatory Authority (SAHPRA)

cipla medpro (pty) ltd - capsules - 100,0 mg - palbociclib

Sør-Afrika - engelsk - South African Health Products Regulatory Authority (SAHPRA)

cipla medpro (pty) ltd - capsules - 125,0 mg - palbociclib

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

cipla australia pty ltd - palbociclib, quantity: 100 mg - capsule, hard - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; sodium starch glycollate type a; colloidal anhydrous silica; titanium dioxide; purified water; iron oxide yellow; iron oxide red; gelatin - cipalon is indicated for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with: ? an aromatase inhibitor as initial endocrine-based therapy ? fulvestrant in patients who have received prior therapy

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

cipla australia pty ltd - palbociclib, quantity: 125 mg - capsule, hard - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; sodium starch glycollate type a; colloidal anhydrous silica; titanium dioxide; purified water; iron oxide yellow; iron oxide red; gelatin - cipalon is indicated for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with: ? an aromatase inhibitor as initial endocrine-based therapy ? fulvestrant in patients who have received prior therapy

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

cipla australia pty ltd - palbociclib, quantity: 75 mg - capsule, hard - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; sodium starch glycollate type a; colloidal anhydrous silica; titanium dioxide; purified water; iron oxide yellow; iron oxide red; gelatin - cipalon is indicated for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with: ? an aromatase inhibitor as initial endocrine-based therapy ? fulvestrant in patients who have received prior therapy

Israel - engelsk - 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 - engelsk - 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 - engelsk - Ministry of Health

astrazeneca (israel) ltd - fulvestrant - solution for injection - fulvestrant 250 mg / 5 ml - fulvestrant - fulvestrant - monotherapyfaslodex 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 therapy faslodex 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.

Den europeiske union - engelsk - EMA (European Medicines Agency)

astrazeneca ab - fulvestrant - breast neoplasms - endocrine therapy, anti-estrogens - faslodex is indicated , as monotherapy 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 antiestrogen therapy, or disease progression on antiestrogen therapy., , , in combination with palbociclib for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. , in pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (lhrh) agonist.,