Code | 8560D | ||||||||||
MA number | 43/0230/21-S | ||||||||||
Product Form: | tbl flm 60x400mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | PRO.MED.CS Praha a.s., Czechia | ||||||||||
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 |