Certificates and Regulatory Documents
1. FDA Approval Certificate
This is the official FDA approval letter for Rybelsus®, confirming its regulatory clearance for the U.S. market. It outlines the approval date and the manufacturer's responsibilities.
📄 Download FDA Approval Letter (PDF)
2. EMA Authorization Document
Provided by the European Medicines Agency, this document includes the full public assessment report and product information approved across the EU region.
📄 Download EMA Authorization Document (PDF)
3. Swissmedic Scientific Assessment
This Swissmedic SwissPAR PDF contains the scientific assessment for Rybelsus in Switzerland, confirming its approval and therapeutic data analysis.
📄 Download Swissmedic Report (PDF)
4. TGA Public Assessment Report
Issued by Australia's Therapeutic Goods Administration, this AUSPAR document provides a comprehensive evaluation of Rybelsus' quality, safety, and efficacy.