Code | 5846B | ||||||||||
MA number | EU/1/15/1023/001 | ||||||||||
Product Form: | cps dur 6x10 mg (blis.PVC/PCTFE/Al) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Pharmaand GmbH, Austria | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 48 | ||||||||||
Container: | blister PVC/CTFE/Alu | ||||||||||
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: | 28.08.2015 |
SmPC + PL: |
|
Safety feature | Yes |
Data update: | 12.10.2022 |