On January 10, 2026, Swissmedic announced a dedicated platform for addressing specific questions related to Good…
Category: Europe
europe updates on medical device regulation and quality.
Swissmedic Approves Temporary Distribution of Enrylaze 10 mg Injection in Select EU Packaging
Swissmedic has granted a temporary authorization for the distribution of Enrylaze 10 mg/vial injection solution in…
Swissmedic Issues Recall of Locametz 25 mcg Multidose Kits for Radiopharmaceutical Use
Swissmedic has announced a precautionary recall of specific batches of Locametz 25 mcg Multidose Kits for…
Swissmedic Expands Therapeutic Indication for Ryeqo®
On 17 December 2025, Swissmedic announced an important regulatory update concerning the medication Ryeqo®. The approval…
Swissmedic Approves Temporary Distribution of Hibidil Sterile Solution in French Packaging
On December 17, 2025, Swissmedic approved a temporary measure allowing the distribution of Hibidil sterile solution…
Critical Updates: Field Safety Alerts Issued for Medical Devices (8–12 December 2025)
Medical device professionals should be aware of the latest Field Safety Notices (FSNs) published between 8–12…
Critical Recall Alert: Prednisolone 5mg Soluble Tablets by Activase Pharmaceuticals
Activase Pharmaceuticals Limited has issued a Class 3 medicines recall for two specific batches of Prednisolone…
Swissmedic Announces Therapeutic Expansion for Blenrep®: Key Updates for Regulatory Teams
On December 13, 2025, Swissmedic announced the extension of the therapeutic indication for Blenrep®, signaling a…
Urgent Recall: Hameln Pharma Ltd Issues Safety Notice for Clarithromycin 500mg Infusion Powder
Hameln Pharma Ltd has issued a Class 2 Medicines recall for specific batches of Clarithromycin 500…
Swissmedic Alerts on Compromised Originality Seals for Urapidil Stragen i.v. – Critical Notice for Healthcare Providers
On December 12, 2025, Swissmedic issued an important notice regarding compromised originality seals on specific packaging…