en

PRODUCT DETAIL

Xyzal

Code 93010
MA number 24/0277/05-S
Product Form: tbl flm 90x5 mg (blis.Al/OPA/Al/PVC)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Mutual recognition procedure
Therapeutic Class: 24 - ANTIHISTAMINICA, HISTAMIN
ATC:
R RESPIRATORY SYSTEM
R06 ANTIHISTAMINES FOR SYSTEMIC USE
R06A ANTIHISTAMINES FOR SYSTEMIC USE
R06AE Piperazine derivatives
R06AE09 Levocetirizine
Shelf life: 48
Container: blister OPA/Al/PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - known active substance
MA issued: 23.08.2005
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
SPC: SPC_Xyzal tbl_12 2022.pdf  
PIL: PIL_Xyzal 5 mg_otc_04/2024.pdf  
PIL: PIL_Xyzal 5mg_rx_04/2024.pdf  
Safety feature Yes
Data update: 22.09.2021
eu-flag.png sk-flag.png