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PRODUCT DETAIL

Grandaxin

Code 03796
MA number 68/0009/77-S
Product Form: tbl 20x50 mg (fľ.skl.)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: National
Therapeutic Class: 68 - ANTIPSYCHOTICA (NEUROLEPTICA)
ATC:
N NERVOUS SYSTEM
N05 PSYCHOLEPTICS
N05B ANXIOLYTICS
N05BA Benzodiazepine derivatives
N05BA23 Tofisopam
Shelf life: 36
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 21.04.1977
PIL: PIL_Grandaxin_08_2023.pdf  
SPC: SPC_Grandaxin_05_2024.pdf  
Safety feature Yes
Data update: 03.05.2024
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