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., Italien |
EU/1/14/987 | 17.02.2015 |
|
|
MACI |
Genzyme Europe B.V., NL |
EU/1/13/847 | 27.06.2013 |
PEI-Sicherheitsinformation: |
|
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 | |
|
t2c001, autologous bone marrow-derived progenitor cells |
t2cure GmbH, Frankfurt |
PEI.A.11517.01.1 | 31.03.2014 |
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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: 03.06.2022
