Dear Doctor Letter (Rote-Hand-Brief) on DepoCyte® 50 mg suspension for injection (liposomal cytarabine for intrathecal injection): Recall of the medicinal product
2012.08.29
Active substance: liposomal cytarabine
During an inspection, critical deficiencies were found at the manufacturing site of the finished product DepoCyte®. Due to the potential risk of lacking sterility the medicinal product is recalled. Patients are to be switched to alternative treatments and until further notice new treatments with DepoCyte® should not be initiated.
European Medicines Agency - Press release and FAQ
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