Code | 0518E | ||||||||||
MA number | EU/1/21/1615/002 | ||||||||||
Product Form: | plc ifc 1x30 mg (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Astellas Pharma Europe B.V., Netherland | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 36 | ||||||||||
Container: | glass vial | ||||||||||
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: | 13.04.2022 |
Validity: | 13.04.2027 |
SmPC + PL: |
|
Safety feature | Yes |
Data update: | 22.04.2022 |