| Code | 1151F | ||||||||||
| MA number | 26/0292/25-S | ||||||||||
| Product Form: | sol inf 10x50 ml/100 mg (vak PP) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Noridem Enterprises Ltd., Cyprus | ||||||||||
| Therapeutic Class: | 26 - ANTIMYCOTICA (LOKÁLNE A CELKOVÉ) | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 23.09.2025 |
| Validity: | 23.09.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| SPC: |
SPC_Fluconazole Noridem 2 mg_ml infúzny roztok_09_2025.pdf
|
| PIL: |
PIL_Fluconazole Noridem 2 mg_ml infúzny roztok_09_2025.pdf
|
| Safety feature | Yes |
| Data update: | 25.09.2025 |
