Code | 5117A | ||||||||||
MA number | 42/0171/13-S | ||||||||||
Product Form: | sol inf 10x100 ml (fľ.PE) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Fresenius Kabi s.r.o., Czechia | ||||||||||
Therapeutic Class: | 42 - CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 26.04.2013 |
Pediatric posology: | Yes |
Pediatric contraindication: | Yes |
SPC: | SPC_Levofloxacin Kabi 5 mg_ml, sol inf_10.2023.pdf |
PIL: | PIL_Levofloxacin Kabi 5 mg_ml_sol inf_03.2024.pdf |
Safety feature | Yes |
Data update: | 14.02.2018 |