Product Approval Information
Proper Name: C1 Esterase Inhibitor (Human)
Tradename: CINRYZE
Manufacturer: Lev Pharmaceuticals, Inc., License #. 1780
STN: 125267/0
Approval Date: October 20, 2008
Note: Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®.
Approval information/letter/labeling
Memorandum/Reviews
- Analytical Method Validation Memo
- Bioresearch Monitoring Final Review memo
- BLA Acknowledgement Letter
- BLA Filing Meeting Memo
- Clinical Pharmacology Review (PDF - 201 KB)
- Evaluation Review Memo
- Filing Letter
- Final Clinical Review (PDF - 729 KB)
- Final Review Memo
- Meeting Summary
- Mid Cycle Review Meeting Memo
- Pharmacology/Toxicology Review Memo (PDF- 194 KB)
- Resubmission Letter
- Review Letter
- Review Decision
- Review of Sponsor’s Responses to CR Letter
- Statistical Review and Evaluation
Administrative Documents