Code | 9351C | ||||||||||
MA number | 15/0285/18-S | ||||||||||
Product Form: | plo ijf 1x2 g (liek.inj.skl.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Noridem Enterprises Ltd., Cyprus | ||||||||||
Therapeutic Class: | 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM) | ||||||||||
ATC: |
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Shelf life: | 30 | ||||||||||
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: | 12.10.2018 |
Validity: | 12.10.2023 |
MA renewed: | Renewal application submitted |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
PIL: | PIL_Cefepím Noridem 1 g a 2 g prášok na injekčný_infúzny roztok_02.2024.pdf |
SPC: | SPC_Cefepím Noridem 1 g a 2 g prášok na injekčný_infúzny roztok_02.2024.pdf |
Safety feature | Yes |
Data update: | 09.11.2018 |