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PRODUCT DETAIL

NULIBRY 9,5 mg prášok na injekčný roztok

Code 2039E
MA number EU/1/22/1684/001
Product Form: plv ino 1x9,5 mg (liek.inj.skl.)
MA Status: Ev - Valid centralised marketing authorisation under exceptional circumstances
Type of procedure: EU Orphan
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
A16AX Various alimentary tract and metabolism products
A16AX19 Fosdenopterin
Shelf life: 24
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: 15.09.2022
Validity: 15.09.2027
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 26.09.2022
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