| Code | 3025E | ||||||||||
| MA number | 44/0062/23-S | ||||||||||
| Product Form: | sol inj 1x1 ml/2,5 mg (liek.inj.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | EVER Valinject GmbH, Austria | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Subcutaneous and intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 11.03.2023 |
| Validity: | 11.03.2028 |
| PIL: |
PIL_Bortezomib EVER Pharma 2,5 mg_ml injekčný roztok_10.2023.pdf
|
| SPC: |
SPC_Bortezomib EVER Pharma 2,5 mg_ml injekčný roztok_04.2024.pdf
|
| Safety feature | Yes |
| Data update: | 08.04.2024 |
