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Switzerland updates on medical device regulation and quality.

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Swissmedic Highlights New Adverse Effect for Neptra Veterinary Eardrops

Swissmedic has issued an important update regarding Neptra eardrops for veterinary use in dogs, emphasizing a newly identified adverse effect…

Europe

Regulatory Update: Temporary Approval for Betaseptic Alcoholic Povidone-Iod Solution 1000 ml in Austria

Swissmedic has announced the temporary authorization for the distribution of Betaseptic Alcoholic Povidone-Iod Solution 1000 ml in Austrian packaging. This…

Europe

Swissmedic Announces Urgent Recall of Veterinary Medicine Buserol Across Multiple Batches

Swissmedic has issued a recall notice for specific batches of the veterinary injectable solution Buserol. The affected batches are 24D167,…

Europe

Critical Batch Recall of Spersallerg SDU 20 Single-Dose Units: Swissmedic Notification

Swissmedic has issued an official recall for specific batches of Spersallerg SDU 20 monodose eye drops. This recall applies to…

Europe

Temporary Approval Granted for Imjudo Infusion Solution in German Packaging

Swissmedic has announced a temporary market authorization for Imjudo, a concentrate used in the preparation of an infusion solution. This…

Europe

Urgent Veterinary Recall: Revozyn RTU 400 mg/ml for Cattle Affected

Swissmedic has issued an urgent announcement concerning the recall of a specific batch of the veterinary medicine Revozyn RTU 400…

Europe

Swissdamed UDI Devices Module Adds Discard Functionality for Compliance Teams

On October 2, 2025, Swissmedic announced a key update to the Swissdamed UDI Devices module. The new discard functionality enables…

Europe

Swissmedic Introduces Preliminary Decision Clarification Meetings for Human Medicinal Products

Swissmedic has announced an important update for stakeholders involved in authorisation procedures for human medicinal products. Starting soon, a new…

Europe

Swissmedic Introduces Horizon Scanning Platform to Enhance Regulatory Oversight

Swissmedic has unveiled a new horizon scanning website to improve proactive regulatory measures. This initiative aims to streamline the identification…

Europe

Scemblix® Gains Extended Therapeutic Indication Approval from Swissmedic

Swissmedic has officially announced an extension of the therapeutic indications for Scemblix®, a drug that plays a pivotal role in…

Europe

Regulatory Update: Swissmedic Confirms Safety of Paracetamol Use During Pregnancy

Swissmedic, Switzerland’s regulatory authority for therapeutic products, has reaffirmed its position on the use of medicines containing paracetamol during pregnancy.…

Europe

Swissmedic Grants Initial Authorisation for VANFLYTA®: Impact on Clinical and Regulatory Practices

Swissmedic has officially authorised VANFLYTA®, marking its initial regulatory approval. This announcement, dated September 30, 2025, highlights a significant development…

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