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Advanced Therapy Medicinal Products (ATMP)

The term "advanced therapy medicinal products" (ATMP) comprises gene therapy medicinal products, somatic cell therapy medicinal products, and tissue engineered products.

The table below lists ATMP which have a valid centralised marketing authorisation for the EU and those which have been exempted from the centralised marketing authorisation and have a national authorisation pursuant to the special provisions of Section 4b AMG.

Products that have been granted a centralised marketing authorisation can be recognised by their marketing authorisation number which begins with the characters EU/…. If the European Medicines Agency (EMA) provides further information in the form of a European Public Assessment Report (EPAR), you will find the corresponding link in the table.

ATMP which have been granted a national authorisation pursuant to Section4b AMG can be recognised by their authorisation number which begins with the characters PEI.A.xxxxx.xx.x.

The table below does not provide any information as to whether the products are available on the market. The information provided here is supplied without liability for errors or omissions. For information which is legally binding, please refer to the relevant marketing authorisation certificate or national authorisation certification. Official publications of the Paul-Ehrlich-Institut appear in the Bundesanzeiger (Federal Gazette).

If SPCs, package leaflets or public assessment reports are available in PharmNet, the gateway for information on medicinal products of the Federal Republic of Germany and the Länder (German Federal states), these are linked in the table directly with the term PharmNet.

The most recent publication included in the section "Medicinal Products" is Federal Gazette publication No 441 (BAnz AT 30.01.2018 B5).

Gene therapy medicinal products

Somatic cell therapy medicinal products

Tumor Vaccines

Tissue engineered products

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