Code | 6157E | ||||||||||
MA number | EU/1/23/1788/001 | ||||||||||
Product Form: | tbl flm 30x200 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: |
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Safety feature | Yes |
Data update: | 17.05.2024 |