| Code | 7927D | ||||||||||
| MA number | 26/0184/21-S | ||||||||||
| Product Form: | lum 1x6,6 ml (fľ.skl.s aplikátorom) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| 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: | glass bottle | ||||||||||
| Route of admin.: | Cutaneous use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 14.07.2021 |
| Validity: | 14.07.2026 |
| MA renewed: | Renewal application submitted |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Exoterin_06_2021.pdf
|
| PIL: |
PIL_Exoterin_03.2023.pdf
|
| Safety feature | No |
| Data update: | 15.07.2021 |
