Code | 1146E | ||||||||||
MA number | EU/1/17/1235/005 | ||||||||||
Product Form: | tbl flm 84x1x100 mg (blis. OPA/Al/PVC/Al/vinyl/akryl-jednotk.bal.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister PCTFE/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: | 16.11.2017 |
SmPC + PL: |
|
Safety feature | Yes |
Data update: | 04.08.2022 |