Code | 9133C | ||||||||||
MA number | EU/1/18/1301/001 | ||||||||||
Product Form: | con inf 1x5 ml/10 mg (liek.skl.) | ||||||||||
MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Ultragenyx Germany GmbH, Germany | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | glass container | ||||||||||
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: | 23.08.2018 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 18.08.2023 |