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PRODUCT DETAIL

Libmeldy

Code 6279D
MA number EU/1/20/1493/001
Product Form: dis inf 1-X x 10-20 ml (vak EVA)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
MAH, country: Orchard Therapeutics (Netherlands) B.V., Netherland
Therapeutic Class: 87 - VARIA I
ATC:
A ALIMENTARY TRACT AND METABOLISM
A16 OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16A OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16AB Enzymes
A16AB21 Atidarsagene autotemcel
Shelf life: 6
Container: bag ethylene vinyl acetate (EVA)
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 17.12.2020
Validity: 17.12.2025
SmPC + PL: European Medicines Agency's database
Safety feature No
Data update: 19.02.2024
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