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

accord healthcare pty ltd - temozolomide, quantity: 20 mg - capsule, hard - excipient ingredients: titanium dioxide; colloidal anhydrous silica; sodium starch glycollate; lactose; iron oxide yellow; gelatin; tartaric acid; purified water; stearic acid; propylene glycol; butan-1-ol; isopropyl alcohol; ethanol; shellac; strong ammonia solution; potassium hydroxide; iron oxide black - treatment of newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment.,treatment of recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy.,temozolomide is also indicated as a first-line treatment for patients with advanced metastatic malignant melanoma.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - entecavir - hepatitis b, chronic - antivirals for systemic use - entecavir accord is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with: , compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis., decompensated liver disease. , for both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with hbeag positive and hbeag negative hbv infection. with respect to patients with lamivudine-refractory hepatitis b. entecavir accord is also indicated for the treatment of chronic hbv infection in nucleoside naive paediatric patients from 2 to

Malta - English - Medicines Authority

accord healthcare limited - nevirapine, anhydrous - prolonged-release tablet - nevirapine, anhydrous 400 mg - antivirals for systemic use

Malta - English - Medicines Authority

accord healthcare limited - midazolam - solution for injection - midazolam 5 mg/ml - psycholeptics

Malta - English - Medicines Authority

accord healthcare limited - olanzapine - film-coated tablet - olanzapine 2.5 mg - psycholeptics

Malta - English - Medicines Authority

accord healthcare limited - olanzapine - film-coated tablet - olanzapine 5 mg - psycholeptics

Malta - English - Medicines Authority

accord healthcare limited - olanzapine - film-coated tablet - olanzapine 7.5 mg - psycholeptics

Malta - English - Medicines Authority

accord healthcare limited - olanzapine - film-coated tablet - olanzapine 10 mg - psycholeptics

Malta - English - Medicines Authority

accord healthcare limited - olanzapine - film-coated tablet - olanzapine 15 mg - psycholeptics

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - caspofungin acetate - candidiasis; aspergillosis - antimycotics for systemic use - treatment of invasive candidiasis in adult or paediatric patients.treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin b, lipid formulations of amphotericin b and/or itraconazole. refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.empirical therapy for presumed fungal infections (such as candida or aspergillus) in febrile, neutropaenic adult or paediatric patients.