| Code | 45749 | ||||||||||
| MA number | EU/1/07/415/032 | ||||||||||
| Product Form: | tbl oro 14x5 mg | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
| Therapeutic Class: | 68 - ANTIPSYCHOTICA (NEUROLEPTICA) | ||||||||||
| ATC: | 
 | ||||||||||
| Shelf life: | 60 | ||||||||||
| 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: | 27.09.2007 | 
| SmPC + PL: |  | 
| Safety feature | Yes | 
| Data update: | 21.06.2018 |