| Code | 8557D | ||||||||||
| MA number | 43/0230/21-S | ||||||||||
| Product Form: | tbl flm 20x400mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| Therapeutic Class: | 43 - CHOLERETICA, CHOLEKINETICA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 12.09.2021 |
| Validity: | 12.09.2026 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| PIL: |
PIL_URSOSAN 400 mg filmom obalené tablety_tbl flm_09/2021_REG.pdf
|
| SPC: |
SPC_URSOSAN 400 mg filmom obalene tablety_08_2022.pdf
|
| Safety feature | Yes |
| Data update: | 27.08.2022 |
