Ireland - English - HPRA (Health Products Regulatory Authority)

astellas pharma co. limited - solifenacin succinate - oral suspension - 1 milligram(s)/millilitre - drugs for urinary frequency and incontinence; solifenacin - urologicals, drugs for urinary frequency and incontinence - symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.

United States - English - NLM (National Library of Medicine)

astellas pharma us, inc. - gilteritinib fumarate (unii: 5rzz0z1gjt) (gilteritinib - unii:66d92mgc8m) - xospata is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (aml) with a fms-like tyrosine kinase 3 (flt3) mutation as detected by an fda-approved test. xospata is contraindicated in patients with hypersensitivity to gilteritinib or any of the excipients. anaphylactic reactions have been observed in clinical trials [see adverse reactions (6) and description (11)] . risk summary based on findings from animal studies (see data) and its mechanism of action, xospata can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on xospata use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, administration of gilteritinib to pregnant rats during organogenesis caused adverse developmental outcomes including embryo-fetal lethality, suppressed fetal growth, and teratogenicity at maternal exposures (auc24 ) approximately 0.4 times the auc

Israel - English - Ministry of Health

astellas pharma international b.v., israel - tacrolimus as monohydrate - capsules prolonged release - tacrolimus as monohydrate 0.5 mg - tacrolimus - prophylaxis of transplant rejection in adult kidney or liver allograft recipients.treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult kidney or liver allograft recipient patients.

Israel - English - Ministry of Health

astellas pharma international b.v., israel - tacrolimus as monohydrate - capsules prolonged release - tacrolimus as monohydrate 1 mg - tacrolimus - prophylaxis of transplant rejection in adult kidney or liver allograft recipients.treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult kidney or liver allograft recipient patients.

Israel - English - Ministry of Health

astellas pharma international b.v., israel - tacrolimus as monohydrate - capsules prolonged release - tacrolimus as monohydrate 3 mg - tacrolimus - prophylaxis of transplant rejection in adult kidney or liver allograft recipients.treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult kidney or liver allograft recipient patients.

Israel - English - Ministry of Health

astellas pharma international b.v., israel - tacrolimus as monohydrate - capsules prolonged release - tacrolimus as monohydrate 5 mg - tacrolimus - prophylaxis of transplant rejection in adult kidney or liver allograft recipients.treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult kidney or liver allograft recipient patients.

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

Philippines - English - FDA (Food And Drug Administration)

for: astellas pharma, inc.; importer: astellas pharma corporation; distributor: zuellig pharma corporation - ramosetron (as hydrochloride) - solution for i.v. injection - 150mcg/ ml (300mcg/ 2ml)

European Union - English - EMA (European Medicines Agency)

astellas pharma gmbh - tacrolimus - dermatitis, atopic - other dermatological preparations - treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).

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

astellas pharma australia pty ltd - tacrolimus, quantity: 5 mg - capsule, modified release - excipient ingredients: lactose monohydrate; titanium dioxide; hypromellose; sodium lauryl sulfate; iron oxide red; magnesium stearate; iron oxide yellow; ethylcellulose; gelatin; hyprolose; butan-1-ol; purified water; industrial methylated spirit; simethicone; lecithin; ethanol; shellac; strong ammonia solution; sulfuric acid - prograf-xl is indicated for use as an adjunct to liver, kidney, lung or heart allograft transplantation in adults and children.