Somatic Cell Therapy Medicinal Products
Somatic cell therapeutics consist of cells and tissues which were substantially processed so that biological and structural characteristics or physiological functions were modified. Besides, they may consist of cells or tissues, or contain such cells or tissues which essentially do not fulfil the same function in the recipient as in the donor (also called non-homologous use). These cells or tissues have pharmacological, immunological, or metabolic effects.
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.