| Code | 6443B | ||||||||||
| MA number | 68/0434/15-S | ||||||||||
| Product Form: | tbl oro 30x15 mg (blis.OPA/Al/PVC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
| Therapeutic Class: | 68 - ANTIPSYCHOTICA (NEUROLEPTICA) | ||||||||||
| ATC: | 
 | ||||||||||
| Shelf life: | 36 | ||||||||||
| 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: | 04.11.2015 | 
| Pediatric indication: | Yes | 
| Pediatric posology: | Yes | 
| Pediatric warnings: | Yes | 
| SPC: |  | 
| PIL: |  | 
| Safety feature | Yes | 
| Data update: | 11.11.2019 |