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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 GmbH, Leipzig

PEI.A.11507.01.1 12.12.2013

Holoclar

Holostem S.r.l., Ital­ien

EU/1/14/987 17.02.2015

EPAR: Holoclar

NOVO­CART 3D

TETEC AG

PEI.A.11511.01.1 29.08.2014 Rote-Hand-Brief: NOVO­CART 3D - au­tologe Chon­drozyten (19.10.2022)

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 GmbH

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

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. 514 in BAnz AT 01.03.2024 B8.

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: 04.03.2024