| Code | 2189B | ||||||||||
| MA number | EU/1/14/945/001 | ||||||||||
| Product Form: | cps dur 90x140 mg (fľ. HDPE) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Janssen - Cilag International N.V., Belgium | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: | 
                
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| Shelf life: | 36 | ||||||||||
| 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: | 21.10.2014 | 
| SmPC + PL: | 
                                                 | 
                
| Safety feature | Yes | 
| Data update: | 12.01.2021 |