Libtayo (cemiplimab) 350 mg concentrate for solution for infusion: Batch / lot number and expiry date may become illegible following sanitisation and wiping of vial label.
Summary:

• The batch / lot number and expiry date on the Libtayo® 350 mg vial label may become illegible upon sanitisation / disinfection followed by physical wiping of the vial during the initial preparation of the infusion.
• The Libtayo batch / lot number and expiry date should be recorded from the vial label before sanitisation / disinfection.
• Neither product efficacy nor patient safety is impacted by this issue.