| Code | 4861B | ||||||||||
| MA number | EU/1/15/1009/010 | ||||||||||
| Product Form: | tbl 98x10 mg (blis.OPA/Al/PVC/Al) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Zentiva k.s., Czechia | ||||||||||
| Therapeutic Class: | 68 - ANTIPSYCHOTICA (NEUROLEPTICA) | ||||||||||
| ATC: | 
                
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| Shelf life: | 24 | ||||||||||
| Container: | blister OPA/Al/PVC/Al | ||||||||||
| Route of admin.: | Oral use | 
| Prescription Status: | Medicinal product subject to medical prescription. | 
| Legal basis: | Article 10(1) generic application | 
| MA issued: | 25.06.2015 | 
| SmPC + PL: | 
                                                 | 
                
| Safety feature | Yes | 
| Data update: | 19.06.2020 |