Libmeldy 2-10 x 106 cells / mL dispersion for infusion
- Licence status
- Active substances
- Autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the Human Arylsulfatase a Gene
- Dosage Form
- Dispersion for infusion
- Licence number
- EU/1/20/1493/001
- Licence holder
- Orchard Therapeutics (Netherlands) B.V.
Product documents
Licence information
- ATC code
- A16AB21 atidarsagene autotemcel
- Legal supply status
- Product subject to prescription which may not be renewed (A)
- Place of sale
- Supply through pharmacies only
- Conditions of Licence
- Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
- Marketing availability
- Unknown
- Advertising conditions
- Advertising to healthcare professionals only
- Licence issued
- 17/12/2020