Code | 6279D | ||||||||||
MA number | EU/1/20/1493/001 | ||||||||||
Product Form: | dis inf 1-X x 10-20 ml (vak EVA) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Orchard Therapeutics (Netherlands) B.V., Netherland | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
|
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Shelf life: | 6 | ||||||||||
Container: | bag ethylene vinyl acetate (EVA) | ||||||||||
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: | 17.12.2020 |
Validity: | 17.12.2025 |
SmPC + PL: |
|
Safety feature | No |
Data update: | 19.02.2024 |