| Code | 4682C | ||||||||||
| MA number | EU/1/15/1063/004 | ||||||||||
| Product Form: | con inf 1x34 ml/850 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: |
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| Safety feature | Yes |
| Data update: | 08.09.2020 |