Code | 8285B | ||||||||||
MA number | EU/1/15/1058/014 | ||||||||||
Product Form: | tbl flm 14x97 mg/103 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Novartis Europharm Limited, Ireland | ||||||||||
Therapeutic Class: | 41 - CARDIACA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 19.11.2015 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 17.10.2023 |