Code | 8874D | ||||||||||
MA number | 24/0261/06-S | ||||||||||
Product Form: | sol por 1x150 ml/75 mg (fľ.skl.jantárová+10ml kalibr.str.) | ||||||||||
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: | 24 | ||||||||||
Container: | amber glass bottle | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 21.06.2006 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_Xyzal 5 mg_10 ml perorálny roztok_12 2022.pdf |
PIL: | PIL_Xyzal 5 mg_10 ml _04/2024.pdf |
Safety feature | Yes |
Data update: | 25.10.2021 |