Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astellas pharma malaysia sdn bhd - tacrolimus -

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

Israel - English - Ministry of Health

astellas pharma international b.v., israel - micafungin as sodium - powder for concentrate for solution for infusion - micafungin as sodium 100 mg - micafungin - adults, adolescents ≥ 16 years of age and elderly:- treatment of invasive candidiasis.- treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate.- prophylaxis of candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation.children (including neonates) and adolescents < 16 years of age:- treatment of invasive candidiasis.- prophylaxis of candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation.the decision to use mycamine should take into account a potential risk for the development of liver tumours. mycamine should therefore only be used if other antifungals are not appropriate.

European Union - English - EMA (European Medicines Agency)

astellas pharma europe b.v. - mirabegron - urinary bladder, overactive - urologicals - symptomatic treatment of urgency.increased micturition frequency and / or urgency incontinence as may occur in adult patients with overactive-bladder syndrome.

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.

European Union - English - EMA (European Medicines Agency)

astellas pharma europe b.v. - gilteritinib fumarate - leukemia, myeloid, acute - antineoplastic agents - xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (aml) with a flt3 mutation.,

European Union - English - EMA (European Medicines Agency)

astellas pharma europe b.v. - micafungin - candidiasis - antimycotics for systemic use - mycamine is indicated for:adults, adolescents ≥ 16 years of age and elderlytreatment of invasive candidiasis;treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate;prophylaxis of candida infection in patients undergoing allogeneic haematopoietic stem-cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µl) for 10 or more days.children (including neonates) and adolescents < 16 years of agetreatment of invasive candidiasis.prophylaxis of candida infection in patients undergoing allogeneic haematopoietic stem-cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µl) for 10 or more days.the decision to use mycamine should take into account a potential risk for the development of liver tumours. mycamine should therefore only be used if other antifungals are not appropriate.

European Union - English - EMA (European Medicines Agency)

astellas pharma europe b.v. - tacrolimus - graft rejection - immunosuppressants - prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients.treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.

Ireland - English - HPRA (Health Products Regulatory Authority)

astellas pharma co. limited - tacrolimus - capsule, hard - 0.5 milligram(s) - calcineurin inhibitors; tacrolimus

Ireland - English - HPRA (Health Products Regulatory Authority)

astellas pharma co. limited - tacrolimus - concentrate for solution for infusion - 5 milligram(s)/millilitre - calcineurin inhibitors; tacrolimus