| Code | 2689F |
| MA number | 92/0049/26-S |
| Product Form: | gto por 1x50 ml (fľ.skl.hnedá) |
| MA Status: | R - Valid Marketing Authorisation |
| Type of procedure: | Decentralised |
| MAH, country: | Alpen Pharma GmbH, Germany |
| Therapeutic Class: | 92 - TRADIČNÉ RASTLINNÉ LIEKY |
| Shelf life: | 24 |
| Container: | brown glass bottle |
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 16a traditional use registration for herbal medicinal product |
| MA issued: | 27.02.2026 |
| Validity: | 27.02.2031 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Omelis 0,8 g_ml perorálne roztokové kvapky_02.2026.pdf
|
| SPC: |
SPC_Omelis 0,8 g_ml perorálne roztokové kvapky_02.2026.pdf
|
| Safety feature | No |
| Data update: | 27.02.2026 |
