| Code | 0753F | ||||||||||
| MA number | 15/0254/25-S | ||||||||||
| Product Form: | tbl flm 5x200 mg (blis.Al/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Sandoz Pharmaceuticals d.d., Slovenia | ||||||||||
| Therapeutic Class: | 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM) | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | blister Al/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 30.07.2025 |
| Validity: | 30.07.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
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| SPC: |
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| Safety feature | Yes |
| Data update: | 01.08.2025 |