Date: 2011-12-19
Type of information: Granting of a Market Authorisation in the EU
Product name: ATG-Fresenius S
Compound: polyclonal antibody
Therapeutic area: Transplantation
Action mechanism: The preparation’s mode of action, which mainly targets activated T-cells, includes complement-mediated cytolysis and apoptotic induction of T-cells and antigen-presenting cells. ATG-Fresenius S prevents the adhesion of T-cells to the endothelium, minimizes T-cell infiltration and blocks numerous signal transmission paths within the immune system.
Company: Fresenius Biotech (Germany)
Disease: prophylaxis of graft-versus-host disease (GVHD) for unrelated stem cell transplant donors in adults
Latest news: ATG-Fresenius S has been approved for GVHD prophylaxis in stem cell transplantations in Germany. Germany is now the fourth country to approve the preparation in this indication, after Argentina, Portugal and Thailand. This polyclonal antibody has already been approved for use in treatment and prophylaxis of acute rejection reactions in the transplantation of solid organs in more than 45 countries. Austria has approved the product on June 6, 2011,
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Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
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UE authorization:
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Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
