Paul-Ehrlich-Institut

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

EPAR EVI­CEL

Rote-Hand-Brief: Quix­il / EVI­CEL Lö­sun­gen für Fib­rin­kle­ber (16.08.2010)

Rote-Hand-Brief: Evi­cel (07.12.2012)

EVI­CEL 2ml

Om­rix Bio­phar­ma­ceu­ti­cals S.A.

EU/1/08/473/002 06.10.2008

EPAR EVI­CEL

Rote-Hand-Brief: Quix­il / EVI­CEL Lö­sun­gen für Fib­rin­kle­ber (16.08.2010)

Rote-Hand-Brief: Evi­cel (07.12.2012)

EVI­CEL 5ml

Om­rix Bio­phar­ma­ceu­ti­cals S.A.

EU/1/08/473/003 06.10.2008

EPAR EVI­CEL

Rote-Hand-Brief: Quix­il / EVI­CEL Lö­sun­gen für Fib­rin­kle­ber (16.08.2010)

Rote-Hand-Brief: Evi­cel (07.12.2012)

TachoSil

Take­da Aus­tria GmbH

EU/1/04/277/001 -004 08.06.2004

EPAR TachoSil

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

EPAR Ve­raSeal

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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. 477 in BAnz AT 16.02.2021 B7.

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: 01.03.2021