Code | 2218D | ||||||||||
MA number | EU/1/18/1341/002 | ||||||||||
Product Form: | plc ifc 1x420 mg (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Biosimilar Collaborations Ireland Limited, Ireland | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 48 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(4) similar biological application |
MA issued: | 12.12.2018 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 09.08.2023 |