Code | 8013D | ||||||||
MA number | EU/1/21/1551/001 | ||||||||
Product Form: | con inf 1x2,3 ml/345 mg (liek.inj.skl.) | ||||||||
MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||
Type of procedure: | EU | ||||||||
MAH, country: | Ultragenyx Germany GmbH, Germany | ||||||||
ATC: |
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Shelf life: | 36 | ||||||||
Container: | glass vial | ||||||||
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: | 17.06.2021 |
Validity: | 17.06.2026 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 26.04.2022 |