| Code | 2452F |
| MA number | 92/0030/26-S |
| Product Form: | tbl obd 50 (blis.PVC/PVDC/Al) |
| MA Status: | R - Valid Marketing Authorisation |
| Type of procedure: | Mutual recognition procedure |
| MAH, country: | Bionorica SE, Germany |
| Therapeutic Class: | 92 - TRADIČNÉ RASTLINNÉ LIEKY |
| Shelf life: | 48 |
| Container: | blister PVC/PVDC/Al |
| 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: | 14.02.2026 |
| Validity: | 14.02.2031 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
|
| SPC: |
|
| Safety feature | No |
| Data update: | 16.02.2026 |