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PRODUCT DETAIL

Orfadin 4 mg/ml perorálna suspenzia

Code 5205B
MA number EU/1/04/303/005
Product Form: sus por 1x90 ml (fľ.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Swedish Orphan Biovitrum International AB, Sweden
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
A16AX04 Nitisinone
Shelf life: 24
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application
MA issued: 19.06.2015
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 19.06.2018
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