Code | 9050E | ||||||||||
MA number | 26/0044/25-S | ||||||||||
Product Form: | tbl ent 48x1x100 mg (blis.PVC/PCTFE-Al - jednotk.bal.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | MSN LABS EUROPE Limited, Malta | ||||||||||
Therapeutic Class: | 26 - ANTIMYCOTICA (LOKÁLNE A CELKOVÉ) | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 14.03.2025 |
Validity: | 14.03.2030 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
PIL: |
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PIL: |
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Safety feature | Yes |
Data update: | 21.03.2025 |