On 26 January 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Trecondi. The marketing authorisation holder for this medicinal product is medac Gesellschaft für klinische Spezialpräparate mbH.
The CHMP adopted an extension to an existing indication to include treatment of non-malignant diseases in paediatric patients undergoing allogeneic haematopoietic stem cell transplantation. For information, the full indication for Trecondi will therefore be as follows:1
Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients with malignant and non‑malignant diseases, and in paediatric patients older than one month with malignant and non‑malignant diseases.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
1 New text in bold, removed text as strikethrough
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Hematopoietic Stem Cell Transplantation
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
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