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

specialised therapeutics pharma pty ltd - lurbinectedin, quantity: 4 mg - injection, powder for - excipient ingredients: sucrose; sodium hydroxide; (s)-lactic acid - zepzelca is indicated for the treatment of patients with metastatic small cell lung cancer (sclc) that has progressed on or after prior platinum-containing therapy. this indication was approved via the provisional approval pathway, based on objective response rate and duration of response in a single arm trial. continued approval for this indication depends on verification and description of clinical benefit in a confirmatory trial.

Reino Unido - inglés - MHRA (Medicines & Healthcare Products Regulatory Agency)

lupin healthcare (uk) ltd - valproate semisodium - gastro-resistant tablet - 500mg

Reino Unido - inglés - MHRA (Medicines & Healthcare Products Regulatory Agency)

lupin healthcare (uk) ltd - valproate semisodium - gastro-resistant tablet - 250mg