Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

astellas pharma us, inc. - enzalutamide (unii: 93t0t9gknu) (enzalutamide - unii:93t0t9gknu) - enzalutamide 40 mg - xtandi® is indicated for the treatment of patients with: none. risk summary the safety and efficacy of xtandi have not been established in females. based on animal reproductive studies and mechanism of action, xtandi can cause fetal harm and loss of pregnancy. there are no human data on the use of xtandi in pregnant females. in animal reproduction studies, oral administration of enzalutamide in pregnant mice during organogenesis caused adverse developmental effects at doses lower than the maximum recommended human dose (see data). data animal data in an embryo-fetal developmental toxicity study in mice, enzalutamide caused developmental toxicity when administered at oral doses of 10 or 30 mg/kg/day throughout the period of organogenesis (gestational days 6-15). findings included embryo-fetal lethality (increased post-implantation loss and resorptions) and decreased anogenital distance at ≥ 10 mg/kg/day, and cleft palate and absent palatine bone at 30 mg/kg/day. doses of 30 mg/kg/day caused maternal toxicity.

Īrija - angļu - HPRA (Health Products Regulatory Authority)

rowex ltd - enzalutamide - film-coated tablet - enzalutamide

Īrija - angļu - HPRA (Health Products Regulatory Authority)

rowex ltd - enzalutamide - film-coated tablet - enzalutamide

Malta - angļu - Medicines Authority

adalvo limited malta life sciences park, building 1, level 4 sir temi zammit san gwann industrial est, sgn 3000 san gwann, malta - lenalidomide - soft capsule - enzalutamide 40 mg - endocrine therapy

Malaizija - angļu - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

dr. reddy`s laboratories malaysia sdn. bhd. - enzalutamide -

Malta - angļu - Medicines Authority

sandoz pharmaceuticals d.d. verovškova ulica 57, si-1000 ljubljana, slovenia - film-coated tablet - enzalutamide 40 mg - endocrine therapy

Malta - angļu - Medicines Authority

sandoz pharmaceuticals d.d. verovškova ulica 57, si-1000 ljubljana, slovenia - film-coated tablet - enzalutamide 80 mg - endocrine therapy

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

astellas pharma australia pty ltd - enzalutamide, quantity: 40 mg - capsule, soft - excipient ingredients: gelatin; purified water; caprylocaproyl macrogolglycerides; butylated hydroxyanisole; butylated hydroxytoluene; titanium dioxide; sorbitol; glycerol; propylene glycol; ethyl acetate; ethanol; isopropyl alcohol; strong ammonia solution; iron oxide black; macrogol 400; polyvinyl acetate phthalate - xtandi is indicated for:,? the treatment of patients with metastatic hormone-sensitive prostate cancer.,? the treatment of patients with non-metastatic castration-resistant prostate cancer (see prosper, section 5.1 clinical trials).,? the treatment of patients with metastatic castration resistant prostate cancer following failure of androgen deprivation therapy in whom chemotherapy is not yet indicated.,? the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.

Izraēla - angļu - Ministry of Health

astellas pharma international b.v., israel - enzalutamide - capsules soft - enzalutamide 40 mg - enzalutamide - xtandi is indicated for:• the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc).• the treatment of adult men with metastatic crpc who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.• the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.

Izraēla - angļu - Ministry of Health

astellas pharma international b.v., israel - enzalutamide - capsules soft - enzalutamide 40 mg - enzalutamide - xtandi is indicated for:•the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc). •the treatment of adult men with metastatic crpc who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. •the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.• the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy