On December 12, 2025, Swissmedic announced the addition of two new members to its Agency Council,…
Category: Europe
europe updates on medical device regulation and quality.
Critical Updates: Field Safety Notices Issued from 1 to 5 December 2025
Clinical, quality, and regulatory teams should take note of the latest Field Safety Notices issued during…
Safety Notice: Flamingo Pharma UK Updates Required in Amitriptyline Hydrochloride PILs
Flamingo Pharma UK Ltd has issued a Class 4 Medicines Defect Notification for Amitriptyline Hydrochloride tablets.…
Swissmedic Announcement: Expanded Indication for Sarclisa®
Swissmedic has issued an important update for healthcare and regulatory professionals regarding Sarclisa®. An extension of…
Swissmedic Launches 2025 Oversight Fee Self-Declaration: Key Details for Medical Device Professionals
Swissmedic, Switzerland’s authority for therapeutic products, has announced the self-declaration deadline for the 2025 oversight fee.…
Swissmedic Expands Therapeutic Indication for Jemperli®
On December 5, 2025, Swissmedic announced an extension to the therapeutic indication for Jemperli®, emphasizing its…
Swissmedic Announces New Extension of Indication for Tevimbra®
On December 5, 2025, Swissmedic published an update regarding the therapeutic indication of Tevimbra®. This regulatory…
Swissmedic Expands Tevimbra® Indication: Key Regulatory Update
Swissmedic, the Swiss Agency for Therapeutic Products, has officially announced the approval of an extended therapeutic…
Swissmedic Warns of Particle Contamination in Rhophylac® (Anti-D Immunoglobulin)
Swissmedic has issued an important update regarding Rhophylac® (human anti-D immunoglobulin), alerting healthcare professionals of a…
Swissmedic Expands Therapeutic Indication for Welireg®
Swissmedic, Switzerland’s medical regulatory authority, has announced an extension of the approved therapeutic indication for the…