| Code | 0396F | ||||||||||
| MA number | 69/0158/25-S | ||||||||||
| Product Form: | pas ord 36x0,6 mg/1,2 mg (blis. PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | MAPAEX CONSUMER HEALTHCARE (IRELAND) PRIVATE LIMITED, Ireland | ||||||||||
| Therapeutic Class: | 69 - OTORHINOLARYNGOLOGICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 48 | ||||||||||
| 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: | 18.07.2025 |
| Validity: | 18.07.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| PIL: |
PIL_Voxsill s príchuťou medu a citrónu_06.2025.pdf
|
| SPC: |
SPC_Voxsill s príchuťou medu a citrónu_06.2025.pdf
|
| Safety feature | No |
| Data update: | 24.07.2025 |
