| Code | 9059E | ||||||||||
| MA number | 26/0044/25-S | ||||||||||
| Product Form: | tbl ent 48x100 mg (blis.Al/Al) | ||||||||||
| 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: | 
 | ||||||||||
| 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: |  | 
| PIL: |  | 
| Safety feature | Yes | 
| Data update: | 21.03.2025 |