Code | 4370C | ||||||||||
MA number | 43/0122/17-S | ||||||||||
Product Form: | tbl flm 20x500 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
Therapeutic Class: | 43 - CHOLERETICA, CHOLEKINETICA | ||||||||||
ATC: |
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Shelf life: | 48 | ||||||||||
Container: | blister PVC/PVDC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 15.06.2017 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric contraindication: | Yes |
SPC: | SPC_URSOSAN FORTE 500 mg filmom obalené tablety_07_2019.docx |
PIL: | PIL_URSOSAN FORTE 500 mg filmom obalené tablety_07_2019.docx |
Safety feature | Yes |
Data update: | 23.12.2021 |