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
europe updates on medical device regulation and quality.
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39 articles in Europe
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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…
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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,…
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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…
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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…
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Swissmedic Advisory: Reduced Shelf Life for Lecigon (Carbidopa/Entacapone/Levodopa)
Swissmedic has issued a health professional communication regarding a change in the shelf life of Lecigon, a medication containing carbidopa,…
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Critical Updates: Field Safety Notices Issued for Medical Devices (13–17 October 2025)
Field Safety Notices (FSNs) issued between 13 and 17 October 2025 have been published, bringing critical updates for clinical, quality,…
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Swissmedic Update: Revised EU Medical Device Regulations Explained
On October 21, 2025, Swissmedic announced updates to key sections related to EU legal acts for medical devices. These revisions…
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Urgent Recall Issued for Nobivac DHPPi Veterinary Injection for Dogs
On October 15, 2025, Swissmedic announced a batch recall of the veterinary medicine Nobivac DHPPi, a lyophilisate designed for the…
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Swissmedic Announces First Authorization for Blenrep®
Swissmedic has officially announced the first authorization of Blenrep®, marking a significant regulatory milestone in its approval process. Clinical, quality,…
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Swissmedic Opens Clinical Assessor Positions: A Vital Role in Regulatory Oversight
Swissmedic has officially announced openings for Clinical Assessors within its Division of Clinical Assessment, offering employment opportunities at an 80-100%…
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Swissmedic Issues Recall for Select Batches of ASS Cardio Spirig HC 100 mg Film-Coated Tablets
On October 8, 2025, Swissmedic issued an immediate recall for specified batches of ASS Cardio Spirig HC 100 mg film-coated…
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