European Union - English - EMA (European Medicines Agency)

astellas pharma europe b.v. - enzalutamide - prostatic neoplasms - endocrine therapy - xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (see section 5.1).the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc) (see section 5.1).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 (see section 5.1).the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.

Canada - English - Health Canada

astellas pharma canada inc - enzalutamide - capsule - 40mg - enzalutamide 40mg - antineoplastic agents

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

astellas pharma ltd - enzalutamide - capsule - 40mg

Israel - English - 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.

Israel - English - 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

Singapore - English - HSA (Health Sciences Authority)

astellas pharma singapore pte. ltd. - enzalutamide - capsule, liquid filled - enzalutamide 40.0 mg

Malta - English - 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

Israel - English - Ministry of Health

astellas pharma international b.v., israel - enzalutamide - film coated tablets - 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

Israel - English - Ministry of Health

astellas pharma international b.v., israel - enzalutamide - film coated tablets - enzalutamide 80 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 ofandrogen 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 docetaxeltherapy.• the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy

Malta - English - Medicines Authority

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