| Code | 5044E | ||||||||||
| MA number | EU/1/23/1767/002 | ||||||||||
| Product Form: | tbl dsp 420 (2x210)x10 mg (fľ.HDPE + 2 odmerky) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 15.11.2023 |
| Validity: | 15.11.2028 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 19.12.2023 |
