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Dear Doctor Letter (Rote-Hand-Brief) on Ceplene^® (0.5 mg/0.5 ml solution for injection): Contamination of the diluent

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) advises healthcare professionals to visually inspect the vial prior to administration of Ceplene^® in order to exclude particle contamination. The background for this recommendation is the discovery of significant shortcomings in the Good Manufacturing Practice (GMP) at Ben Venue Laboratories, the manufacturing site where Ceplene^® is produced.

A  Rote-Hand-Brief on Ceplene® (file size: 71 KB) will be circulated.