Code | 8206B | ||||||||||
MA number | EU/1/15/1063/002 | ||||||||||
Product Form: | con inf 1x20 ml/500 mg (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Actavis Group PTC ehf., Iceland | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 18 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 18.01.2016 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 08.09.2020 |