On December 5, 2025, Swissmedic published an update regarding the therapeutic indication of Tevimbra®. This regulatory…
Category: Switzerland
Switzerland updates on medical device regulation and quality.
Swissmedic Expands Tevimbra® Indication: Key Regulatory Update
Swissmedic, the Swiss Agency for Therapeutic Products, has officially announced the approval of an extended therapeutic…
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…
Swissmedic Expands Therapeutic Indication for Welireg®
Swissmedic, Switzerland’s medical regulatory authority, has announced an extension of the approved therapeutic indication for the…
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…
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…
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…
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…
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…
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…