Code | 93001 | ||||||||||
MA number | 24/0277/05-S | ||||||||||
Product Form: | tbl flm 4x5 mg (blis.Al/OPA/Al/PVC) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | UCB s.r.o., Czechia | ||||||||||
Therapeutic Class: | 24 - ANTIHISTAMINICA, HISTAMIN | ||||||||||
ATC: |
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Shelf life: | 48 | ||||||||||
Container: | blister OPA/Al/PVC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product not 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 | No |
Data update: | 22.09.2021 |