Code | 3983B | ||||||||||
MA number | 42/0154/15-S | ||||||||||
Product Form: | sol inf 5x100 ml/500 mg (liek.inj.skl.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
Therapeutic Class: | 42 - CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 22.04.2015 |
Pediatric contraindication: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Levalox 5 mg_ml_sol inf_01_2024.pdf |
SPC: | SPC_Levalox 5 mg_ml_sol inf_01_2024.pdf |
Safety feature | Yes |
Data update: | 30.12.2019 |