Code | 8425E | ||||||||||
MA number | EU/1/24/1866/001 | ||||||||||
Product Form: | con inf 1x20 ml/100 mg (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | AbbVie Deutschland GmbH & Co. KG, Germany | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 60 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intravenous use |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 14.11.2024 |
Validity: | 14.11.2029 |
SmPC + PL: |
|
Safety feature | Yes |
Data update: | 17.12.2024 |