| Code | 4023E | ||||||||||
| MA number | EU/1/23/1742/002 | ||||||||||
| Product Form: | con inf 1x10 ml/10 mg (liek.inj.skl.) | ||||||||||
| MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Roche Registration GmbH, Germany | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
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| Shelf life: | 30 | ||||||||||
| 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: | 07.07.2023 |
| Validity: | 10.07.2025 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Columvi_Karta pacienta.pdf
|
| Dokument: |
Columvi_Prirucka pre zdravotnickych pracvnikov.pdf
|
| Safety feature | Yes |
| Data update: | 18.06.2024 |
