Code | 4377C | ||||||||||
MA number | 15/0178/17-S | ||||||||||
Product Form: | plc ifc 10x1 g (liek.inj.skl.) | ||||||||||
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: | 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: | 16.06.2017 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Ertapenem Fresenius Kabi 1 g_plc ifc_08.2022.pdf |
SPC: | SPC_Ertapenem Fresenius Kabi 1 g_plc ifc_08.2022.pdf |
Safety feature | Yes |
Data update: | 14.01.2021 |