| Code | 5060E | ||||||||||
| MA number | 15/0265/23-S | ||||||||||
| Product Form: | plo ijf 10x500 mg (liek.inj.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Antibiotice S.A, 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 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Merocarb 500 mg_11_2023.pdf
|
| SPC: |
SPC_Merocarb 500 mg_11_2023.pdf
|
| Safety feature | Yes |
| Data update: | 21.12.2023 |
