| Code | 0539F | ||||||||||
| MA number | 69/0221/25-S | ||||||||||
| Product Form: | pas ord 8x3 mg/1 mg (blis. PVC/PE/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
| Therapeutic Class: | 69 - OTORHINOLARYNGOLOGICA | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | blister PVC/PE/PVDC/Al | ||||||||||
| Route of admin.: | Oromucosal use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 04.07.2025 |
| Validity: | 04.07.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| SPC: |
SPC_Septolete extra s príchuťou koly 3 mg/1 mg tvrdé pastilky_pas ord_07/2025_REG.pdf
|
| PIL: |
PIL_Septolete extra s príchuťou koly 3 mg/1 mg tvrdé pastilky_pas ord_07/2025_REG.pdf
|
| Safety feature | No |
| Data update: | 09.07.2025 |
