Swissmedic announces the first authorisation of Tepezza®. This development is significant for quality, clinical, and regulatory…
Category: Switzerland
Switzerland updates on medical device regulation and quality.
Swissmedic Authorizes Temporary Distribution of Glucose 5% Infusion Solution in German Packaging
Swissmedic has announced a temporary approval for the distribution of Glucose 5% B. Braun Infusionslösung in…
Swissmedic Approves Temporary Distribution of NaCl 0.9% Infusion in Foreign Packaging
On November 26, 2025, Swissmedic announced the temporary approval for distribution of NaCl 0.9% infusion solution…
Swissmedic Announces Financial Consolidation Plan Amid Regulatory Priorities
Swissmedic, Switzerland’s key regulatory authority for therapeutic products, has outlined measures to strengthen its financial position.…
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).…