| Code | 5919E | ||||||||||
| MA number | 15/0072/24-S | ||||||||||
| Product Form: | plo ijf 10x1 g (fľ.inj.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | AS KALCEKS, Latvia | ||||||||||
| Therapeutic Class: | 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM) | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intramuscular or intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 27.04.2024 |
| Validity: | 27.04.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Ceftriaxone Kalceks 1g a 2g prášok na injekčný_infúzny roztok_08.2024.pdf
|
| SPC: |
SPC_Ceftriaxone Kalceks 1g a 2g prášok na injekčný_infúzny roztok_08.2024.pdf
|
| Safety feature | Yes |
| Data update: | 02.05.2024 |
