Drug Type Recombinant coagulation factor |
Synonyms Fibrin Sealant Patch, Absorbable(Takeda Pharma), Fibrin sealant patch (Takeda), Human fibrinogen/Human thrombin(CSL Behring) + [5] |
Target |
Mechanism Fibrinogen modulators, prothrombin modulators(Prothrombin modulators) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date AT (31 Dec 1992), |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Tissue Adhesions | JP | 26 Sep 2011 | |
Hemorrhage | US | 05 Apr 2010 | |
Hemorrhage | US | 05 Apr 2010 | |
Blood Coagulation Disorders | IS | 08 Jun 2004 | |
Blood Coagulation Disorders | EU | 08 Jun 2004 | |
Blood Coagulation Disorders | LI | 08 Jun 2004 | |
Blood Coagulation Disorders | NO | 08 Jun 2004 | |
Cerebrospinal Fluid Leak | IS | 08 Jun 2004 | |
Cerebrospinal Fluid Leak | EU | 08 Jun 2004 | |
Cerebrospinal Fluid Leak | LI | 08 Jun 2004 | |
Cerebrospinal Fluid Leak | NO | 08 Jun 2004 | |
Wounds and Injuries | RU | - | |
Wounds and Injuries | KR | - | |
Wounds and Injuries | DE | - |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Hemorrhage | Phase 3 | - | 25 Nov 2024 | |
Intraoperative Complications | Discovery | DK | 01 Feb 2006 | |
Lung Diseases | Discovery | DK | 01 Feb 2006 | |
Liver Diseases | Discovery | DK | 01 Oct 2005 |
Not Applicable | 23 | (MTI+Tachosil) | tecvewupod(ijdazoygzl) = no significant changes in PDUSS scores post-operatively ehcpojzdyz (efucbjorxf ) View more | - | 01 Sep 2021 | ||
Phase 3 | 142 | (No TachoSil® patches) | ykcnrifjut(gwesaleeyj) = jupaululbh rnnzggdkot (rkdvpckwjs ) View more | Negative | 01 Sep 2018 | ||
Phase 3 | 150 | (TachoSil®) | gjbklmgxlz(mtpkaigglj) = zrgroygaar vgqemsofwa (zqblkjxwuq, hfkhrzkgmq - jvanmwiayz) View more | - | 08 Feb 2017 | ||
Surgicel® Original (Surgicel® Original) | gjbklmgxlz(mtpkaigglj) = pwfqfgtkxh vgqemsofwa (zqblkjxwuq, mrtsctazrl - fusttxjsig) View more | ||||||
Phase 3 | 253 | (TachoSil® (Adult Participants)) | zmfamwoqun(twddofyreg) = ykwbavdxep yclorqcxdk (doncfjuzis, pgitkpgdza - qiixnkpfxj) View more | - | 25 Nov 2015 | ||
Surgicel (Surgicel® Original (Adult Participants)) | zmfamwoqun(twddofyreg) = hjczukpzeo yclorqcxdk (doncfjuzis, iafzeudzen - cdzbiytmii) View more |