| Code | 4997C | ||||||||||
| MA number | 69/0252/17-S | ||||||||||
| Product Form: | pas ord 16x3 mg/1 mg (blis.PVC/PE/PVDC//Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
| Therapeutic Class: | 69 - OTORHINOLARYNGOLOGICA | ||||||||||
| ATC: |
|
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| Shelf life: | 48 | ||||||||||
| 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: | 23.08.2017 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| SPC: |
SPC_Septolete extra s príchuťou citrónu a bazového kvetu 3 mg/1 mg_06/2023.pdf
|
| PIL: |
PIL_Septolete extra s príchuťou citrónu a bazového kvetu 3 mg/1 mg_06/2023.pdf
|
| Safety feature | No |
| Data update: | 14.06.2023 |
