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Libmeldy



Orchard Therapeutics (Netherlands) B.V.EU/1/20/1493/001

Main Information

Trade NameLibmeldy
Active SubstancesAutologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex
Dosage FormDispersion for infusion
Licence HolderOrchard Therapeutics (Netherlands) B.V.
Licence NumberEU/1/20/1493/001

Group Information

ATC CodeA16AB21 atidarsagene autotemcel

Status

License statusAuthorised
Licence Issued17/12/2020
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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