Code | 84132 | ||||||||||
MA number | EU/1/09/591/003 | ||||||||||
Product Form: | tbl flm 60x400 mg (blis.PVC/Al) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Sanofi Winthrop Industrie, France | ||||||||||
Therapeutic Class: | 13 - ANTIARRYTHMICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister PVC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 26.11.2009 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 27.09.2019 |