| Code | 28784 | ||||||||||
| MA number | 68/0148/99-S | ||||||||||
| Product Form: | tbl obd 30x25 mg (blist.PVC/PVDC) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | National | ||||||||||
| MAH, country: | Teva B.V., Netherland | ||||||||||
| Therapeutic Class: | 68 - ANTIPSYCHOTICA (NEUROLEPTICA) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 42 | ||||||||||
| Container: | blister PVC/PVDC | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 28.10.1999 |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Zoleptil 25mg_03.2020.doc
|
| PIL: |
PIL_Zoleptil 25mg_03.2020.doc
|
| Safety feature | Yes |
| Data update: | 24.05.2018 |
