Drug Type Recombinant coagulation factor |
Synonyms Fibrin sealant patch (Takeda), Fibrin Sealant Patch, Absorbable(Takeda Pharma), human fibrinogen / human thrombin(Takeda Pharmaceuticals International GmbH) + [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 | EU | 08 Jun 2004 | |
Blood Coagulation Disorders | IS | 08 Jun 2004 | |
Blood Coagulation Disorders | LI | 08 Jun 2004 | |
Blood Coagulation Disorders | NO | 08 Jun 2004 | |
Cerebrospinal Fluid Leak | EU | 08 Jun 2004 | |
Cerebrospinal Fluid Leak | IS | 08 Jun 2004 | |
Cerebrospinal Fluid Leak | LI | 08 Jun 2004 | |
Cerebrospinal Fluid Leak | NO | 08 Jun 2004 | |
Wounds and Injuries | AT | 31 Dec 1992 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Intraoperative Complications | Phase 3 | DK | 01 Feb 2006 | |
Lung Diseases | Phase 3 | DK | 01 Feb 2006 | |
Liver Diseases | Phase 3 | DK | 01 Oct 2005 |
Not Applicable | 23 | (MTI+Tachosil) | dlrqwhefou(tuicapxsae) = no significant changes in PDUSS scores post-operatively inszxyagmn (vhysxmcnya ) View more | - | 01 Sep 2021 | ||
Phase 3 | 142 | (No TachoSil® patches) | (orpdzudgjq) = iegdnwkodf eaburwwpti (xhyuffaiuj ) View more | Negative | 01 Sep 2018 | ||
Phase 3 | 150 | (TachoSil®) | aaezhvaurf(dqocqrcgbc) = xdrzvgwsee aovyasfexa (pkoclxwmhg, nngavyouea - fufmiarchh) View more | - | 08 Feb 2017 | ||
Surgicel® Original (Surgicel® Original) | aaezhvaurf(dqocqrcgbc) = glavqcxtoi aovyasfexa (pkoclxwmhg, wxccemjecd - hkfpojvtjj) View more | ||||||
Phase 3 | 253 | (TachoSil® (Adult Participants)) | ujrhjpqgxa(kibytprmtv) = nimcmcotbg okfqnqojfr (mnrtieingj, ytbyirijft - fakmrruuka) View more | - | 25 Nov 2015 | ||
Surgicel (Surgicel® Original (Adult Participants)) | ujrhjpqgxa(kibytprmtv) = qxbwoflnwd okfqnqojfr (mnrtieingj, wpwjnugjzw - qwmtxaocjc) View more |