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PRODUCT DETAIL

Voxzogo 1,2 mg prášok a rozpúšťadlo na injekčný roztok

Code 8537D
MA number EU/1/21/1577/003
Product Form: plv iol 10x0,6 ml/1,2 mg (liek.inj.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
Therapeutic Class: 87 - VARIA I
ATC:
M MUSCULO-SKELETAL SYSTEM
M05 DRUGS FOR TREATMENT OF BONE DISEASES
M05B DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION
M05BX Other drugs affecting bone structure and mineralization
M05BX07 Vosoritide
Shelf life: 24
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: 26.08.2021
Validity: 26.08.2026
SmPC + PL: European Medicines Agency's database
Dokument: DHPC_Voxzogo_nova striekacka a ihla v baleni_17-07-2023.pdf  
Safety feature Yes
Data update: 08.09.2021
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