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Stem Cell Preparations

These include stem cell preparations from cord blood, peripheral blood, and bone marrow used for the reconstitution of bone marrow as haematopoetic or immunological organ, i.e. for the purpose of haematopoetic reconstitution.

Non-targeted allogeneic stem cell preparations from cord blood, i.e. preparations from donations not intended for a particular recipient are subject to the obligation to maintain a marketing authorisation pursuant to Section 21 AMG (Arzneimittelgesetz, Medicinal Products Act).

Targeted allogeneic stem cell preparations as well as autologous stem cell preparations from cord blood, peripheral blood and bone-marrow are subject to an authorisation pursuant to Section 21a, subsection 1 AMG. For the first placing of the stem cell preparations from member states of the EU on the German market, a certification pursuant to Section 21a, subsection 9, AMG is required.

These include stem cell preparations from cord blood, peripheral blood, and bone marrow used for the reconstitution of bone marrow as haematopoetic or immunological organ, i.e. for the purpose of haematopoetic reconstitution.

Non-targeted allogeneic stem cell preparations from cord blood, i.e. preparations from donations not intended for a particular recipient are subject to the obligation to maintain a marketing authorisation pursuant to Section 21 AMG (Arzneimittelgesetz, Medicinal Products Act).

Targeted allogeneic stem cell preparations as well as autologous stem cell preparations from cord blood, peripheral blood and bone-marrow are subject to an authorisation pursuant to Section 21a, subsection 1 AMG. For the first placing of the stem cell preparations from member states of the EU on the German market, a certification pursuant to Section 21a, subsection 9, AMG is required.

The table below lists stem cell preparations which have a valid marketing authorisation pursuant to Section 25, subsection 1 AMG, a valid authorisation pursuant to Section 21a, subsection 1 AMG, or a certification pursuant to Section 21, subsection 9. Preparation that have been granted a marketing authorisation can be recognised by their marketing authorisation number which begins with the characters: PEI.H.xxxxx.xx.x. Preparations that have been granted an authorisation/certification bear numbers starting: PEI.G.xxxxx.xx.x..

The list does not provide information as to whether the products are also 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. Official publications of the Paul-Ehrlich-Institut appear in the Bundesanzeiger (Federal Gazette).

Where the European Medicines Agency (EMA) provides further information, you will find a link called EPAR.

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 with the term PharmNet.

The most recent publication included in the section "Medicinal Products" is Federal Gazette publication No 438 (BAnz AT 13.10.2017 B6).

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Search results 1 to 25 from a total of 351 (15 pages)

Search results 1 to 25 from a total of 351 (15 pages)

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