| Code | 1382D | ||||||||||
| MA number | 26/0143/19-S | ||||||||||
| Product Form: | lum 1x3 ml (fľ.skl.jantárová+30 tamp.+10 špachtlí+30 pilník.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Sandoz Pharmaceuticals d.d., Slovenia | ||||||||||
| Therapeutic Class: | 26 - ANTIMYCOTICA (LOKÁLNE A CELKOVÉ) | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | amber glass bottle | ||||||||||
| Route of admin.: | Local use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 15.05.2019 |
| Validity: | 15.05.2024 |
| Pediatric warnings: | Yes |
| PIL: |
PIL_EXOROLFIN 5%_lum_01.2025.pdf
|
| SPC: |
SPC_EXOROLFIN 5%_lum_01.2025.pdf
|
| Safety feature | No |
| Data update: | 21.01.2025 |
