| Code | 5163B | ||||||||||
| MA number | 69/0311/15-S | ||||||||||
| Product Form: | pas ord 8x3 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: |
|
||||||||||
| 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: | 27.07.2015 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| PIL: |
PIL_Septolete extra eukalyptus 3 mg-1 mg pas ord_03.2023.pdf
|
| SPC: |
SPC_Septolete extra eukalyptus 3 mg-1 mg pas ord_03.2023.pdf
|
| Safety feature | No |
| Data update: | 27.09.2022 |
