| Code | 8028E | ||||||||||
| MA number | 15/0297/24-S | ||||||||||
| Product Form: | sol ijf 1x2 ml/250 mg (amp.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Noridem Enterprises Ltd., Cyprus | ||||||||||
| Therapeutic Class: | 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM) | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | glass ampoule | ||||||||||
| Route of admin.: | Intramuscular or intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 25.11.2024 |
| Validity: | 25.11.2029 |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Amikacin Noridem_sol ijf_11 2024.pdf
|
| SPC: |
SPC_Amikacin Noridem_sol ijf_11 2024.pdf
|
| Safety feature | Yes |
| Data update: | 27.11.2024 |
