Code | 8498D | ||||||||||
MA number | EU/1/21/1574/004 | ||||||||||
Product Form: | tbl flm 12x1x100 mg (blis.PVC/Al - jednotk.bal.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Astellas Pharma Europe B.V., Netherland | ||||||||||
Therapeutic Class: | 12 - ANTIANAEMICA | ||||||||||
ATC: |
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Shelf life: | 48 | ||||||||||
Container: | blister PVC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 18.08.2021 |
Validity: | 18.08.2026 |
SmPC + PL: |
|
Safety feature | Yes |
Data update: | 06.07.2023 |