Code | 8494D | ||||||||||
MA number | EU/1/21/1539/001 | ||||||||||
Product Form: | dis inf 1x50 ml (250 ml, 100 ml) (vak EVA) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 12 | ||||||||||
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: | 18.08.2021 |
Validity: | 19.03.2029 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | No |
Data update: | 26.03.2024 |