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PRODUCT DETAIL

Elfabrio 2 mg/ml koncentrát na infúzny roztok

Code 3588E
MA number EU/1/23/1724/001
Product Form: con inf 1x10 ml/20 mg (liek.inj.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
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
A16AB20 Pegunigalsidase alfa
Shelf life: 48
Container: glass vial
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: 04.05.2023
Validity: 04.05.2028
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 10.05.2023
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