Swissmedic Warns of Particle Contamination in Rhophylac® (Anti-D Immunoglobulin)
Swissmedic has issued an important update regarding Rhophylac® (human anti-D immunoglobulin), alerting healthcare professionals of a contamination risk associated with…
Switzerland
Switzerland updates on medical device regulation and quality.
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156 articles in Switzerland
Europe
Europe
Swissmedic Expands Therapeutic Indication for Welireg®
Swissmedic, Switzerland’s medical regulatory authority, has announced an extension of the approved therapeutic indication for the cancer treatment Welireg®. This…
Europe
Swissmedic Opens Recruitment for Experienced Software Architect in Regulatory IT
Swissmedic, Switzerland’s key authority for the oversight of therapeutic products, has recently issued a call for an experienced Software Architect…
Europe
Swissmedic Opens Role for Cloud Engineering Expertise in Medical Device Regulation
Swissmedic, Switzerland’s authority for medical devices and therapeutic products, announces an exciting cloud engineering position. Key stakeholders in clinical, quality,…
Europe
Swissmedic Updates Guidance: Packaging Leaflets for Healthcare-Only Medicines Optional
Effective December 1, 2025, Swissmedic, Switzerland’s therapeutic products regulator, has announced a significant change to its packaging guidance for human…
Europe
Temporary Approval Announced for Sales of Opdivo 240 mg Infusion Solution in Italian Packaging
Swissmedic has issued a temporary approval enabling the distribution of Opdivo 240 mg/24 ml concentrate for infusion solution in Italian-language…
Europe
Swissmedic Grants Temporary Approval for Nemluvio Injection Pen Packaging in German
Swissmedic has announced the temporary authorization of Nemluvio—or Nemluvio Pulver und Lösungsmittel zur Herstellung einer Injektionslösung im Fertigpen—for distribution within…
Europe
International Council for Harmonisation Convenes: Regulatory Updates for Pharmaceuticals Highlighted
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) convened its Assembly meeting in Singapore…
Europe
Important Patient-Level Recall: Algifor Junior Suspension 200 ml and Algifor Dolo Junior Suspension 200 ml
Swissmedic issues a patient-centric recall for specific batches of Algifor Junior Suspension 200 ml and Algifor Dolo Junior Suspension 200…
Europe
Swissmedic Announces New Therapeutic Indication for Tepkinly®
Swissmedic has announced an update to the therapeutic indications for Tepkinly®. This regulatory approval marks an extension of the product’s…
Europe
Swissmedic Approves Enhertu® for Extended Therapeutic Indications
Swissmedic has granted authorization for the extension of therapeutic indications for Enhertu® as of November 28, 2025. This update marks…
Europe
Temporary Authorization Alert: Ringerfundin B. Braun Infusion Solution Distribution Update
Swissmedic, the Swiss Agency for Therapeutic Products, has granted a temporary approval for the distribution of Ringerfundin B. Braun Infusion…
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