On November 27, 2025, Swissmedic announced an immediate recall of batch number 100062289 of Azelastin-Fluticason-Mepha Nasal…
Category: Switzerland
Switzerland updates on medical device regulation and quality.
Urgent Swissmedic Batch Recall: Lexotanil 3mg Tablets
On 26 November 2025, Swissmedic issued an official notice regarding the immediate recall of batch 1653102…
Swissmedic Grants Initial Authorisation for Tepezza®: Key Implications for Regulatory Teams
Swissmedic announces the first authorisation of Tepezza®. This development is significant for quality, clinical, and regulatory…
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,…