Paul-Ehrlich-Institut

Tis­sue En­gi­neered Prod­ucts

A tissue engineered product (TEP) is a biological medicinal product that contains bioengineered cells or tissues or consists of the latter. It serves the regeneration, restoration, or replacement of human tissue.

Name Mar­ket­ing Au­tho­ri­sa­tion Hold­er Li­cense Num­ber Li­cense Date Further Information

BioSeed-C Au­tolo­ges 3D-Chon­drozy­ten­trans­plan­tat, 28,8 Mio. Zellen pro Ein­heit

Bi­o­Tis­sue Tech­no­log­ics GmbH

PEI.A.11485.01.1 04.06.2014

co.don chon­dro­sphere, 10-70 Sphäroide/cm2, ma­trix­as­sozi­ierte Zellen zur Im­plan­ta­tion

co.don AG, Tel­tow

PEI.A.11507.01.1 12.12.2013

Holoclar

Holostem Ter­apie Avan­zate (HTA) S.r.l., Macao

EU/1/14/987 17.02.2015

EPAR: Holoclar

MACI

Gen­zyme Eu­rope B.V., NL

EU/1/13/847 27.06.2013

PEI-Sicher­heits­in­for­ma­tion:
Ruhen der Zu­las­sung (siehe Bekan­nt­machung Nr. 404 vom 08.12.2014)

EPAR: MACI

MukoCell

Muko­Cell GmbH

PEI.A.11491.01.1 23.12.2013

NOVO­CART 3D

TETEC AG

PEI.A.11511.01.1 29.08.2014

NOVO­CART In­ject

TETEC AG

PEI.A.11763.01.1 27.06.2016

Ob­ni­tix

medac Gesellschaft für klin­is­che Spezial­prä­parate mbH

PEI.A.11748.01.1 24.08.2016

Spherox

co.don AG, Tel­tow

EU/1/17/1181 10.07.2017

EPAR: Spherox

t2c001, au­tol­o­gous bone mar­row-de­rived pro­gen­i­tor cells

t2cure GmbH, Frank­furt

PEI.A.11517.01.1 31.03.2014

Hints

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. 482 in BAnz AT 15.07.2021 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: 15.07.2021