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Prescribing Information SmPC

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Libmeldy: Ex vivo autologous HSC gene therapy for early-onset MLD

Libmeldy is an autologous haematopoietic stem cell (HSC) gene therapy product for early-onset MLD made specifically for each patient using the patient’s own blood stem cells.1

See indication

Abbreviations
ARSA, arylsulfatase A; cDNA, complementary DNA; HSC, haematopoietic stem cell; MLD, metachromatic leukodystrophy

For any medical questions, please contact medinfo@orchard-tx.com

▼ This medicinal product is subject to additional monitoring.
Healthcare professionals are asked to report any suspected adverse events. Further information about local reporting details can be found in Section 4.8 of the Summary of Product Characteristics.

Please also report any adverse events to Orchard Therapeutics at: drugsafety@orchard-tx.com

References

  1. Libmeldy, Summary of Product Characteristics. March 2021
  2. Rosenberg JB, et al. J Neurosci Res 2016; 94(11): 1169-1179.

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IMPORTANT: Product information on this website is based on the European Summary of Product Characteristics (EU SmPC)
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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions according to their national guidelines.