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New medicines and opinions: human

Human medicines European public assessment report (EPAR): Winlevi, clascoterone, Status: Opinion
Human medicines European public assessment report (EPAR): Syfovre, pegcetacoplan, Status: Application withdrawn
Human medicines European public assessment report (EPAR): Dazublys, trastuzumab, Date of authorisation: 30/06/2025, Status: Authorised
Human medicines European public assessment report (EPAR): Nurzigma, pridopidine, Status: Opinion under re-examination
Human medicines European public assessment report (EPAR): Jelrix, autologous cartilage-derived articular chondrocytes, in-vitro expanded, Status: Opinion under re-examination

Green Lumber Holding, LLC Issues Consumer Alert on Counterfeit Products Following FDA Findings
Breathing Circuit Set Recall: Hamilton Medical, Inc. Removes Coaxial Breathing Circuit Set Due to Possible Inner Blue Tube Cracks That May Impact Ventilation
Manual Resuscitator Recall: Ambu Inc. Removes SPUR II Resuscitators Due to Blocked Manometer Port
Mobile Power Unit AC Power Cord Recall: Abbott Medical Removes AC Power Cord Associated with HeartMate Mobile Power Unit (MPU) Due to Potential Risk of the Cord Not Locking into Place
Applicator Recall: Integra LifeSciences Removes Extended Tip Applicator Due to Potential Sterility and Endotoxin Concerns

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