| Code | 5865B | ||||||||||
| MA number | EU/1/15/1023/009 | ||||||||||
| Product Form: | cps dur 24x20 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 |