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258 articles
258 articles in Europe
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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 radiopharmaceutical applications. Clinical teams,…

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Swissmedic Expands Therapeutic Indication for Ryeqo®

On 17 December 2025, Swissmedic announced an important regulatory update concerning the medication Ryeqo®. The approval marks an extension of…

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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 in French-language packaging within…

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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 December 2025. These updates…

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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 5mg Soluble Tablets as…

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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 significant development in its…

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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 mg powder for concentrate…

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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 units of Urapidil Stragen…

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Swissmedic Announces Appointment of Two New Members to Agency Council for 2026–2029 Term

On December 12, 2025, Swissmedic announced the addition of two new members to its Agency Council, marking a crucial step…

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Critical Updates: Field Safety Notices Issued from 1 to 5 December 2025

Clinical, quality, and regulatory teams should take note of the latest Field Safety Notices issued during the first week of…

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Safety Notice: Flamingo Pharma UK Updates Required in Amitriptyline Hydrochloride PILs

Flamingo Pharma UK Ltd has issued a Class 4 Medicines Defect Notification for Amitriptyline Hydrochloride tablets. The Patient Information Leaflets…

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Swissmedic Announcement: Expanded Indication for Sarclisa®

Swissmedic has issued an important update for healthcare and regulatory professionals regarding Sarclisa®. An extension of the therapeutic indication has…

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