en

PRODUCT DETAIL

Zoleptil 25 mg

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:
N NERVOUS SYSTEM
N05 PSYCHOLEPTICS
N05A ANTIPSYCHOTICS
N05AX Other antipsychotics
N05AX11 Zotepine
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
eu-flag.png sk-flag.png