STN: BL 125351
Proper Name: TACHOSIL® Fibrin Sealant Patch
Manufacturer: Takeda Pharma A/S, License #1894
- TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
Clinical Review Memo-TachoSil(PDF - 1013KB)
- August 5, 2015 Approval Letter - TachoSil (PDF - 45KB)
To include changes to the Full Prescribing Information.
July 20, 2015 Summary Basis for Regulatory Action - TachoSil(PDF - 71KB) June 23, 2015 Statistical Review - TachoSil(PDF - 1.6MB) April 5, 2010 Approval Letter - TachoSil Summary Basis for Regulatory Action - TachoSil, March 31, 2010(PDF - 689KB) Approval History, Letters, Reviews, and Related Documents - TachoSil[ARCHIVED]
FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
FDA Approves First Biodegradable Sealant Patch for Cardiovascular Surgery[ARCHIVED]
Press Release, Posted: 4/5/2010