| Code | 5780A | ||||||||||
| MA number | 26/0249/13-S | ||||||||||
| Product Form: | tbl flm 2x200 mg (blis.PVC/PVDC/Al) | ||||||||||
| 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: | 24 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 10.06.2013 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
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| PIL: |
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| Safety feature | Yes |
| Data update: | 31.01.2019 |