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PRODUCT DETAIL

Givlaari 189 mg/ml injekčný roztok

Code 3726D
MA number EU/1/20/1428/001
Product Form: sol inj 1x1 ml/189 mg (liek.inj.skl.)
MA Status: E - Valid centralised marketing authorisation
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
A16AX16 Givosiran
Shelf life: 36
Container: glass vial
Route of admin.: Subcutaneous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 02.03.2020
Validity: 02.03.2025
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 08.09.2021
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