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 an important milestone in…
Switzerland
Switzerland updates on medical device regulation and quality.
156 articles
156 articles in Switzerland
Europe
Europe
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, 2025, this authorisation introduces…
Europe
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 extended the therapeutic…
Europe
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). This announcement highlights crucial…
Europe
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 French-language packaging. This regulatory…
Europe
Swissmedic Updates: New Measures to Address Suicide Risk with Finasteride and Dutasteride
On November 18, 2025, Swissmedic announced new measures to mitigate the risk of suicidal thoughts associated with the use of…
Europe
Swissmedic’s Multilingual Initiative: Vigilance-News Now Available in Four Languages
Swissmedic has announced an important update to its Vigilance-News publication, ensuring accessibility for a broader audience. Starting with Edition 35,…
Europe
Swissmedic Releases Haemovigilance Annual Report 2024 With Key Findings on Transfusion Safety
Swissmedic, the Swiss agency for therapeutic products, has published its Haemovigilance Annual Report for the year 2024. The report evaluates…
Europe
Swissmedic Issues Recall for GlucoSaline B. Braun Infusion Solution Batch
Swissmedic has announced a recall of batch number 242867651 for the product GlucoSaline B. Braun Infusion Solution. This action affects…
Europe
Swissmedic Updates: Safety Revisions to Product Information Starting November 2025
Swissmedic has announced a significant update regarding the publication of safety-related revisions to product information. Effective November 2025, clinicians, regulatory…
Europe
Swissmedic Announces Initial Authorisation of ZYNYZ® – Key Updates for Industry Professionals
Swissmedic has granted the first authorisation for ZYNYZ®, marking a significant regulatory milestone. This development signals an important step for…
Europe
Swissmedic Grants First Authorization for DATROWAY®: A Regulatory Milestone
On November 14, 2025, Swissmedic officially announced the first authorization of DATROWAY®, marking an important step in regulatory approvals for…
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