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GMP shortcomings at Ben Venue Laboratories (BVL), manufacturer of the active substance: Several centrally authorised oncology medicines concerned

Due to considerable shortcomings in adhering to Good Manufacturing Practice (GMP) at the Ben Venue Laboratories in the USA, the manufacturer of the active substance, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) assessed and in part recalled the centrally authorised medicinal products Busilvex^®, Caelyx^®, Velcade^® and Vidaza^®.

risk information - full text (available in German only)