Malta - angleščina - Medicines Authority

janssen-cilag international nv turnhoutsewes 30, b-2340 beerse, belgium - itraconazole - hard capsule - itraconazole 100 mg - antimycotics for systemic use

Irska - angleščina - HPRA (Health Products Regulatory Authority)

janssen sciences ireland uc - itraconazole - oral solution - 10 milligram(s)/millilitre - triazole derivatives; itraconazole

Irska - angleščina - HPRA (Health Products Regulatory Authority)

janssen sciences ireland uc - itraconazole - capsule, hard - 100 milligram(s) - triazole derivatives; itraconazole

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - itraconazole, quantity: 10 mg/ml - oral liquid, solution - excipient ingredients: propylene glycol; hydroxypropylbetadex; saccharin sodium; purified water; caramel; sorbitol solution (70 per cent) (non-crystallising); sodium hydroxide; hydrochloric acid; flavour - sporanox oral solution is indicated for: * the treatment of oral and/or oesophageal candidiasis in hiv-positive or other immunocompromised patients. * prophylaxis of fungal infections in neutropenic patients.

Irska - angleščina - HPRA (Health Products Regulatory Authority)

janssen sciences ireland uc - itraconazole - concentrate and solvent for solution for infusion - 10 milligram(s)/millilitre - triazole derivatives; itraconazole

Irska - angleščina - HPRA (Health Products Regulatory Authority)

athlone pharmaceuticals limited - itraconazole - oral solution - triazole derivatives; itraconazole

Velika Britanija - angleščina - MHRA (Medicines & Healthcare Products Regulatory Agency)

hra pharma uk ltd - ketoconazole - tablet - 200mg

Evropska unija - angleščina - 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.

Avstralija - angleščina - 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.

Velika Britanija - angleščina - MHRA (Medicines & Healthcare Products Regulatory Agency)

astellas pharma ltd - enzalutamide - capsule - 40mg