| Code | 7812E | ||||||||||
| MA number | 26/0249/24-S | ||||||||||
| Product Form: | shp 1x60 g (fľ.HDPE) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Dr. Max Pharma s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 26 - ANTIMYCOTICA (LOKÁLNE A CELKOVÉ) | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Cutaneous use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 14.11.2024 |
| Validity: | 14.11.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Ketokonazol Dr. Max_11.2024.pdf
|
| SPC: |
SPC_Ketokonazol Dr. Max_11.2024.pdf
|
| Safety feature | No |
| Data update: | 20.11.2024 |
