Product Details for: Lenmeldy

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Suspension
Intravenous
2 x 10^6 to 11.8 x 10^6CELL/ML
Bag
351(a)
Lenmeldy
Rx
Proper Name
atidarsagene autotemcel
BLA Number
125758
Applicant
Orchard Therapeutics (Europe) Ltd.
Original Approval Date
March 18, 2024
Date of First Licensure
03/18/2024
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