| Code | 3875D | ||||||||||
| MA number | 15/0066/20-S | ||||||||||
| Product Form: | sol inf 10x50 ml (fľ.LDPE) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Fresenius Kabi s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM) | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | bottle LDPE | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 03.04.2020 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Amikacin Fresenius Kabi 5 mg_ml_sol inf_04.2024.pdf
|
| SPC: |
SPC_Amikacin Fresenius Kabi 5 mg_ml_sol inf_04.2024.pdf
|
| Safety feature | Yes |
| Data update: | 05.08.2024 |
