Code | 0832C | ||||||||||
MA number | EU/1/15/1060/003 | ||||||||||
Product Form: | plv ifo 1x30 mg (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Amgen Europe B.V., Netherland | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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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: | 19.11.2015 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 14.04.2022 |