Code | 9509B | ||||||||
MA number | EU/1/16/1097/001 | ||||||||
Product Form: | dis inf 1x50 ml (vak.etylénvinylacetát-EVA) | ||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||
Type of procedure: | EU Orphan | ||||||||
MAH, country: | Fondazione Telethon ETS, Italy | ||||||||
ATC: |
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Shelf life: | 6 hodín | ||||||||
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: | 26.05.2016 |
Validity: | 30.05.2026 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | No |
Data update: | 26.07.2023 |