Swissmedic, the Swiss agency for therapeutic products, has announced the first regulatory authorization for Ayvakyt®. This…
Category: Europe
europe updates on medical device regulation and quality.
Swissmedic Grants Initial Authorization for Wainzua®: Key Regulatory Update
Swissmedic, the Swiss agency responsible for licensing and monitoring therapeutic products, has announced the initial authorization…
Tamsulosin and Its Association with Intraoperative Floppy Iris Syndrome: Swissmedic Insights
Swissmedic has issued an important notice about the risks of intraoperative floppy iris syndrome (IFIS) among…
Swissmedic Updates on Veterinary Drug Reactions: Key Insights from 2024 Reports
The latest vigilance report from Swissmedic highlights significant findings regarding adverse reactions to veterinary medicinal products…
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,…
Duplicate GTIN and EAN Numbers Raise Concerns for Relonchem Ltd Medicines
Healthcare professionals, regulators, and distributors should take note of a critical update related to Relonchem Ltd…
Urgent Recall: Incorrect Labelling Found in Accord Healthcare’s Ipratropium Bromide Nebuliser Solution
An urgent recall has been issued for Ipratropium Bromide 500 microgram/2ml Nebuliser Solution by Accord Healthcare…
Swissmedic Approves Initial Authorization for Sogroya®: Key Details for Regulatory Professionals
Swissmedic has announced the first authorization for Sogroya®, marking a significant regulatory development. The approval introduces…
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…
Swissmedic Update: Revised EU Medical Device Regulations Explained
On October 21, 2025, Swissmedic announced updates to key sections related to EU legal acts for…