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PRODUCT DETAIL

ATARAX

Code 85060
MA number 70/0891/92-CS
Product Form: tbl flm 25x25 mg (blis. PVC/Al)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: National
Therapeutic Class: 70 - ANXIOLYTICA
ATC:
N NERVOUS SYSTEM
N05 PSYCHOLEPTICS
N05B ANXIOLYTICS
N05BB Diphenylmethane derivatives
N05BB01 Hydroxyzine
Shelf life: 60
Container: blister PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 30.12.1992
Pediatric posology: Yes
Pediatric warnings: Yes
Dokument: DHPC Hydroxyzine_ 20 4 2015.pdf  
PIL: PIL_ATARAX_02.2023.pdf  
SPC: SPC_ATARAX_02.2023.pdf  
Safety feature Yes
Data update: 12.04.2018
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