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PRODUCT DETAIL

Bylvay 1200 mikrogramov tvrdé kapsuly

Code 8206D
MA number EU/1/21/1566/004
Product Form: cps dur 30x1200 µg (fľ.HDPE)
MA Status: Ev - Valid centralised marketing authorisation under exceptional circumstances
Type of procedure: EU Orphan
Therapeutic Class: 43 - CHOLERETICA, CHOLEKINETICA
ATC:
A ALIMENTARY TRACT AND METABOLISM
A05 BILE AND LIVER THERAPY
A05A BILE THERAPY
A05AX Other drugs for bile therapy
A05AX05 Odevixibat
Shelf life: 24
Container: bottle HDPE
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 16.07.2021
Validity: 16.07.2026
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 29.07.2021
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