| Code | 5625D |
| MA number | 92/0222/20-S |
| Product Form: | sir 1x150 ml (fľ.skl.hnedá+odmerka) |
| MA Status: | R - Valid Marketing Authorisation |
| Type of procedure: | Decentralised |
| MAH, country: | Opella Healthcare Slovakia s.r.o., Slovakia |
| Therapeutic Class: | 92 - TRADIČNÉ RASTLINNÉ LIEKY |
| Shelf life: | 24 |
| Container: | 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: | 14.10.2020 |
| Validity: | 14.10.2025 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Skorocelový sirup_07.2021.pdf
|
| PIL: |
PIL_Skorocelový sirup_03.2025.pdf
|
| Safety feature | No |
| Data update: | 16.01.2023 |
