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…
Switzerland
Switzerland updates on medical device regulation and quality.
156 articles
156 articles in Switzerland
Europe
Europe
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,…
Europe
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…
Europe
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…
Europe
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…
Europe
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…
Europe
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…
Europe
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…
Europe
Swissmedic Launches 2025 Oversight Fee Self-Declaration: Key Details for Medical Device Professionals
Swissmedic, Switzerland’s authority for therapeutic products, has announced the self-declaration deadline for the 2025 oversight fee. Medical device manufacturers, clinical…
Europe
Swissmedic Expands Therapeutic Indication for Jemperli®
On December 5, 2025, Swissmedic announced an extension to the therapeutic indication for Jemperli®, emphasizing its crucial role in the…
Europe
Swissmedic Announces New Extension of Indication for Tevimbra®
On December 5, 2025, Swissmedic published an update regarding the therapeutic indication of Tevimbra®. This regulatory decision expands the scope…
Europe
Swissmedic Expands Tevimbra® Indication: Key Regulatory Update
Swissmedic, the Swiss Agency for Therapeutic Products, has officially announced the approval of an extended therapeutic indication for Tevimbra®. This…
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