Code | 9610D | ||||||||||
MA number | 15/0028/22-S | ||||||||||
Product Form: | plc ifc 1x1g (liek.inj.skl.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
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: | 17.03.2022 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Ertapenem AptaPharma 1 g prášok na koncentrát na infúzny roztok_09.2022.pdf |
SPC: | SPC_Ertapenem AptaPharma 1 g prášok na koncentrát na infúzny roztok_09.2022.pdf |
Safety feature | Yes |
Data update: | 08.11.2022 |