| Code | 8504D | ||||||||||
| MA number | EU/1/19/1385/004 | ||||||||||
| Product Form: | sol por 2x50 ml (fľ.skl.jantár.) | ||||||||||
| MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Bayer AG, Germany | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 19.09.2019 |
| Validity: | 23.09.2025 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 05.08.2024 |
