Paul-Ehrlich-Institut Permits the Import of Atgam with French Labelling
Atgam is a medicinal product used in adults and children aged 2 years and older to treat acquired moderate to severe aplastic anaemia of known or suspected immunological aetiology. It is used as part of standard immunosuppressive therapy in patients who are unsuitable for haematopoietic stem cell transplantation (HSCT) or for whom an appropriate donor of haematopoietic stem cells (HSC) is not available. Atgam contains anti-human T-lymphocyte immunoglobulin derived from horses. The supply shortage is expected to last from 2 July 2025 to 30 November 2025. In order to ensure the availability of the medicinal product during this time, the Paul-Ehrlich-Institut has permitted the marketing authorisation holder Pfizer Pharma GmbH, pursuant to section 10 subsection 1a and section 11 subsection 1c of the Medicinal Products Act (Arzneimittelgesetz, AMG), to place packs of Atgam 50 mg/ml concentrate for the preparation of an infusion solution on the market in Germany in the period from 15 August 2025 to 30 November 2025. The product is expected to be available on the German market from 15 September 2025. These products are pharmaceutically identical to the product with German labelling and differ only in their packaging.
Details
- The commercial name of this French-labelled product is also "Atgam".
- The text on the syringe label, in the package leaflet, and on the folding box is in French.
- The medicinal products are in their original packaging, which does not contain a German package leaflet.
- The German package leaflet and the summary of product characteristics are available for download on this page.
- German product name: Atgam 50 mg/ml Konzentrat zur Herstellung einer Infusionslösung
- Special PZN: 20131170
- Batch number: LT7111
- Expiration date: 30 September 2026
French-labelled product Atgam.
Source: Pfizer Pharma GmbH
Background
The Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines, is the higher federal authority responsible in Germany for the quality, safety, efficacy, and official batch release of vaccines and biomedicines. It also advocates for the availability of these medicinal products, which include immunoglobulins.