| 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 | ||||||||||
| MAH, country: | UCB s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 24 - ANTIHISTAMINICA, HISTAMIN | ||||||||||
| ATC: |
|
||||||||||
| 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 |
