Code | 8536D | ||||||||||
MA number | EU/1/21/1577/002 | ||||||||||
Product Form: | plv iol 10x0,7 ml/0,56 mg (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | BioMarin International Limited, Ireland | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
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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: | 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: | 18.06.2024 |