| Code | 6158E | ||||||||||
| MA number | EU/1/23/1788/002 | ||||||||||
| Product Form: | tbl flm 30x400 mg (fľ.HDPE) | ||||||||||
| MA Status: | Ex - Conditional centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Vifor France S.A., France | ||||||||||
| Therapeutic Class: | 41 - CARDIACA | ||||||||||
| ATC: |
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| Shelf life: | 48 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 19.04.2024 |
| Validity: | 19.04.2025 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 17.05.2024 |
