On November 18, 2025, Swissmedic announced new measures to mitigate the risk of suicidal thoughts associated…
Category: Europe
europe updates on medical device regulation and quality.
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.…
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…
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…
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…
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…
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…
Swissmedic Grants First Authorization for Pylclari®: Key Updates for Regulatory Teams
On November 14, 2025, Swissmedic officially announced the first regulatory authorization of Pylclari®, marking an important…
Swissmedic Announces Enhanced Use of Enhertu® for Extended Therapeutic Indications
Swissmedic, Switzerland’s regulatory authority for therapeutic products, has announced the authorization of an extended therapeutic indication…
Urgent Medicines Recall: Atorvastatin 20mg & 80mg Tablets from Sun Pharma Due to Stability Concerns
Sun Pharma UK Limited has issued a precautionary recall of specific batches of their Atorvastatin 20mg…