Swissmedic has issued a health professional communication regarding a change in the shelf life of Lecigon,…
Category: Europe
europe updates on medical device regulation and quality.
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…
Temporary Authorization Issued for Seroquel XR 50 mg Tablets in Italian Packaging
On October 20, 2025, Swissmedic announced a temporary resolution to the supply shortage of Seroquel XR…
Swissmedic Grants Initial Approval for Imcivree®: What You Need to Know
Swissmedic has officially granted the initial authorisation for Imcivree®. This significant regulatory decision is vital for…
Swissmedic Announces Limited Distribution Approval for Opdivo 40 mg/4 ml Infusion Concentrate Amid Supply Challenges
Swissmedic has issued a temporary authorization permitting the distribution of Opdivo 40 mg/4 ml Konzentrat zur…
Urgent Recall of Similasan Schnupfen Globuli Batch 17900 Announced by Swissmedic
On October 16, 2025, Swissmedic issued an urgent announcement regarding the recall of batch 17900 of…