Between 10 and 14 November 2025, significant Field Safety Notices (FSNs) were announced, carrying potential implications…
Category: Europe
europe updates on medical device regulation and quality.
Swissmedic Confirms First Authorisation for Lutathera®: Key Regulatory Update
On November 22, 2025, Swissmedic published an important regulatory update announcing the first authorisation of Lutathera®,…
Swissmedic Expands Use of Breyanzi®: Updated Authorization Details
On November 22, 2025, Swissmedic announced the extension of the therapeutic indication for Breyanzi® (lisocabtagene maraleucel).…
Swissmedic Authorizes 18F-PSMA-1007 ZRP®: Key Insights for Regulatory and Clinical Teams
On November 22, 2025, Swissmedic officially granted the first authorization of 18F-PSMA-1007 ZRP®. This approval represents…
Swissmedic Grants First Authorisation of Radelumin®: A Regulatory Milestone
Swissmedic has announced the first authorisation of Radelumin®, marking a significant regulatory achievement. Effective November 22,…
Swissmedic Update: Expanded Indication Approval for NexoBrid®
Swissmedic, Switzerland’s medical regulatory authority, has announced an important update regarding NexoBrid®. On November 22, 2025,…
Swissmedic Issues DHPC for DIBASE® 10’000 to Address Handling Errors
On November 22, 2025, Swissmedic released a Direct Healthcare Professional Communication (DHPC) concerning DIBASE® 10’000 (cholecalciferolum).…
Precautionary Recall of Fingolimod SUN 0.5mg by Sun Pharma: Capsule Breakage Risk Emerges
Sun Pharma UK Limited has issued a precautionary recall for one batch of Fingolimod SUN 0.5…
Feedback Requested: Consultation on SaMD ‘Predetermined Change Control Plans’ Closing December 2025
The Software as a Medical Device (SaMD) Working Group has invited stakeholders to review and comment…
Temporary Approval Issued for Selectol 200 mg Tablets in French Packaging
Swissmedic has issued a temporary authorization allowing the distribution of Selectol 200 mg film-coated tablets in…