77 In the second place, as regards the comparison between Trecondi-treosulfan and cyclophosphamide-based medicinal products, first, it must be noted that, according to the SmPCs for the latter medicinal products, as authorised in Germany, which have been placed in the file by the applicant, they are indicated, other than for chemotherapy treatment of certain conditions, for ‘conditioning prior to bone marrow transplantation’ in the case of certain pathological conditions that are exhaustively listed (severe aplastic anaemia; acute myeloid leukaemia and acute lymphoblastic leukaemia; chronic myelogenous leukaemia), in contrast, therefore, to the SmPC of Trecondi-treosulfan which covers conditioning treatment prior to an HSC transplantation for all types of malignant and non-malignant pathological conditions in adults.
Olen ollut kirjastossaEuroParl2021 EuroParl2021