Code | 8529B | ||||||||||
MA number | EU/1/14/952/004 | ||||||||||
Product Form: | tbl flm 30x800 mg (fľ.HDPE) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Sanofi B.V., Netherland | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10c informed consent application |
MA issued: | 11.02.2016 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 15.11.2019 |