Code | 4327E | ||||||||||
MA number | 15/0164/23-S | ||||||||||
Product Form: | plo ijf 1x2 g (liek.inj.skl.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Apta Medica Internacional d.o.o., Slovenia | ||||||||||
Therapeutic Class: | 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM) | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
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: | 14.09.2023 |
Validity: | 14.09.2028 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
PIL: | PIL_Cefepime AptaPharma_09_2023.pdf |
SPC: | SPC_Cefepime AptaPharma_09_2023.pdf |
Safety feature | Yes |
Data update: | 18.09.2023 |