Swissmedic Updates Guidance: Packaging Leaflets for Healthcare-Only Medicines Optional
Effective December 1, 2025, Swissmedic, Switzerland’s therapeutic products regulator, has announced a significant change to its packaging guidance for human…
Switzerland
Switzerland updates on medical device regulation and quality.
24 articles
24 articles in Switzerland
Europe
Europe
Important Patient-Level Recall: Algifor Junior Suspension 200 ml and Algifor Dolo Junior Suspension 200 ml
Swissmedic issues a patient-centric recall for specific batches of Algifor Junior Suspension 200 ml and Algifor Dolo Junior Suspension 200…
Europe
Swissmedic Expands Use of Breyanzi®: Updated Authorization Details
On November 22, 2025, Swissmedic announced the extension of the therapeutic indication for Breyanzi® (lisocabtagene maraleucel). This change has important…
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 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 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 for Enhertu®. This update…
Europe
Swissmedic Opens Bids for Advanced Document and Records Management System: A Regulatory Update
On November 3, 2025, Swissmedic, the Swiss agency for therapeutic products, announced its initiative to procure a state-of-the-art Document and…
Europe
Swissmedic Publishes November Safety Updates for Healthcare Professionals
Swissmedic has issued new safety-related updates this November 2025, designed to inform healthcare professionals and regulatory teams about important changes…
Europe
Swissmedic Updates Key Information on Drug Safety Reporting – What You Need to Know
Swissmedic has announced an update to its Drug Safety Reporting Duties in Switzerland information sheet. The adjustments include revised contact…
Europe
Swissmedic Updates Signal Management Guidance in PSUR Reporting
Swissmedic has released an update to its guidance document regarding the Authorisation PSUR Signal Management TAM process, effective November 1,…
Europe
Safety Alert: Recall of NaCl B. Braun Infusion Solution Batch
Swissmedic has issued an announcement regarding the immediate recall of batch number 251347651 of NaCl B. Braun infusion solution. This…
Europe
Swissmedic Expands Therapeutic Indication for Palforzia®
Swissmedic, Switzerland’s agency for the authorization and supervision of therapeutic products, has announced an extension of the therapeutic indication for…
Loading more articles…