| Code | 8346B | ||||||||||
| MA number | 69/0002/16-S | ||||||||||
| Product Form: | pas ord 36x0,60 mg/1,20 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Dr. Max Pharma s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 69 - OTORHINOLARYNGOLOGICA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/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: | 25.02.2016 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Orasept mentol_pas ord_12_2022.pdf
|
| PIL: |
PIL_Orasept mentol_08/2024.pdf
|
| Safety feature | No |
| Data update: | 02.12.2020 |
