| Code | 2191C | ||||||||||
| MA number | EU/1/16/1138/004 | ||||||||||
| Product Form: | tbl flm 7 (7x1)x50 mg (blis.PVC/PE/PCTFE/Al-jednotl.dávka) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | AbbVie Deutschland GmbH & Co. KG, Germany | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: | 
 | ||||||||||
| Shelf life: | 24 | ||||||||||
| Container: | blister PVC/PE/PCTFE/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: | 05.12.2016 | 
| SmPC + PL: |  | 
| Safety feature | Yes | 
| Data update: | 30.08.2023 |