Paul-Ehrlich-Institut · July 29, 2026

Recall: Libtayo (Cemiplimab) 350 mg concentrate for infusion solution, batch 8494100007, quality defect

Original title: Informationsschreiben von Regeneron GmbH: Libtayo (Cemiplimab)

Regeneron recalls one batch of Libtayo (Cemiplimab) 350 mg due to a sealing defect in the vial.

Low obligation Product class Pharmaceuticals Germany Pharmacovigilance

Rückruf von Libtayo (Cemiplimab) 350 mg Konzentrat zur Herstellung einer Infusionslösung (EU/1/19/1376/001, Charge 8494100007) aufgrund eines Qualitätsmangels: Verbördelungsfehler

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