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TRECONDI (Link Medical Products Pty Ltd T/A Link Pharmaceuticals)
Product name
TRECONDI
Date registered
Evaluation commenced
Decision date
Approval time
221 (255 working days)
Active ingredients
treosulfan
Registration type
NCE/NBE
Indication
Adults with acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS)
TRECONDI (treosulfan) is indicated in combination with fludarabine as part of conditioning treatment prior to allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult patients with AML or MDS at increased risk for standard conditioning therapies.
Paediatric patients aged 1 month and older with malignant and non-malignant haematological diseases
TRECONDI (treosulfan) is indicated in combination with fludarabine, with or without thiotepa, as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in paediatric patients older than one month with malignant and non-malignant diseases.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.