Code | 5059E | ||||||||||
MA number | 15/0266/23-S | ||||||||||
Product Form: | plo ijf 10x1 g (liek.inj.skl.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | ANTIBIOTICE SA, Romania | ||||||||||
Therapeutic Class: | 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM) | ||||||||||
ATC: |
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Shelf life: | 48 | ||||||||||
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: | 19.12.2023 |
Validity: | 19.12.2028 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
PIL: | PIL_Merocarb 1 g_11_2023.pdf |
SPC: | SPC_Merocarb 1 g_11_2023.pdf |
Safety feature | Yes |
Data update: | 21.12.2023 |