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258 articles in Europe
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Swissmedic Announces Recall of Ringerfundin B. Braun Batch Due to Quality Issues

On January 10, 2026, Swissmedic issued an official recall notice regarding specific batches of Ringerfundin B. Braun Infusionslösung. This recall…

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Swissmedic Announces Recall of Specific Batches of Esomeprazol MUT Sandoz Tablets

On January 10, 2026, Swissmedic issued an announcement concerning the recall of designated batches of Esomeprazol MUT Sandoz gastro-resistant tablets.…

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Swissmedic Expands Therapeutic Indication Approval for Pemazyre®

Swissmedic, the Swiss agency responsible for the authorisation and supervision of therapeutic products, recently approved an extension for the therapeutic…

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Temporary Approval for Sevelamer Carbonate 800 mg Tablets in German Packaging

Swissmedic has issued a temporary marketing authorization for Sevelamercarbonate Salmon Pharma 800 mg film-coated tablets in German packaging. This development…

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Swissmedic Announces Paper Leaflet Alternatives for Veterinary Medicines Starting 2026

Swissmedic has announced a significant change in packaging requirements for certain veterinary medicinal products. Starting January 1, 2026, it will…

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European Pharmacopoeia 12.1 Enforcement Date Announced: Key Implications for Compliance

On January 1, 2026, the European Pharmacopoeia version 12.1 officially comes into force. Regulatory professionals, quality assurance teams, and clinical…

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Revised Annex 7 TPLRO Variations Take Effect February 2026

A key regulatory development for the healthcare sector is set to take place early next year. A revised list of…

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Swissmedic Authorizes Temporary Distribution of Xenpozyme in Taiwanese Packaging

On January 10, 2026, Swissmedic announced the temporary authorization for the distribution of Xenpozyme Pulver zur Herstellung einer Lösung zur…

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Swissmedic Highlights Medication Mix-Up: Phosphonorm® Erroneously Administered Instead of Phoscap

In a recent pharmacovigilance update dated January 10, 2026, Swissmedic reported an important issue regarding a specific medication mix-up involving…

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Swissmedic Opens Recruitment for Product Owner Role in Regulatory Operations

Swissmedic, the Swiss agency responsible for therapeutic products, is seeking a Product Owner to join its Operational Support Services division.…

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Swissmedic Offers Targeted GMP/GDP Consultations for Regulatory Clarity

On January 10, 2026, Swissmedic announced a dedicated platform for addressing specific questions related to Good Manufacturing Practices (GMP) and…

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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 distinct packaging formats from…

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