Fibrin Sealant
Fibrin sealant (also called tissue adhesive) is a two-component glue consisting of components of natural blood coagulation and thus biological material. If the two components are combined at the treated site in the body, they form a blood clot.
Name | Marketing Authorisation Holder | License Number | License Date | Further Information |
---|---|---|---|---|
ARTISS |
Baxter Deutschland GmbH |
PEI.H.03593.01.1 | 05.03.2009 | |
Beriplast P Combi-Set 0,5 ml |
CSL Behring GmbH |
PEI.H.00322.01.1 | 11.08.1998 | |
Beriplast P Combi-Set 1 ml |
CSL Behring GmbH |
PEI.H.00322.02.1 | 11.08.1998 | |
Beriplast P Combi-Set 3 ml |
CSL Behring GmbH |
PEI.H.00322.03.1 | 11.08.1998 | |
EVICEL 1ml |
Omrix Biopharmaceuticals S.A. |
EU/1/08/473/001 | 06.10.2008 |
Rote-Hand-Brief: Quixil / EVICEL Lösungen für Fibrinkleber (16.08.2010) |
EVICEL 2ml |
Omrix Biopharmaceuticals S.A. |
EU/1/08/473/002 | 06.10.2008 |
Rote-Hand-Brief: Quixil / EVICEL Lösungen für Fibrinkleber (16.08.2010) |
EVICEL 5ml |
Omrix Biopharmaceuticals S.A. |
EU/1/08/473/003 | 06.10.2008 |
Rote-Hand-Brief: Quixil / EVICEL Lösungen für Fibrinkleber (16.08.2010) |
TachoSil |
Takeda Austria GmbH |
EU/1/04/277/001 -004 | 08.06.2004 | Schreiben von Takeda: TachoSil (Fibrinogen vom Menschen/Thrombin vom Menschen) (29.01.2016): neue Empfehlungen zur Reduzierung des Darmverschluss-Risikos |
TISSEEL 2ml |
Baxter Deutschland GmbH |
PEI.H.11728.01.1 | 22.08.2014 | |
TISSEEL 4ml |
Baxter Deutschland GmbH |
PEI.H.11728.02.1 | 22.08.2014 | |
TISSEEL 10ml |
Baxter Deutschland GmbH |
PEI.H.11728.03.1 | 22.08.2014 | |
VeraSeal |
Instituto Grifols, S.A., E |
EU/1/17/1239 | 10.11.2017 |
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Disclaimer
The list of medicines contains the products that have a valid marketing authorization. It contains no information as to whether the preparations are available on the market.
The information contained in the Federal Gazette, which is the official publication organ of the Paul-Ehrlich-Institut, is legally binding.
As of: PEI announcement No. 492 in BAnz AT 06.04.2022 B6.
Summary of Product Characteristics (SmPCs) and the Package Leaflet (PL)
Where the European Medicines Agency (EMA) offers further information, you will find a link to the EPAR (European public assessment report) in the table.
If user and technical information or public assessment reports are available in PharmNet.Bund, the Federal and State Pharmaceutical Information Portal, these are directly linked to PharmNet.Bund in the table.
Updated: 07.04.2022