| Code | 5703D | ||||||||||
| MA number | 43/0231/20-S | ||||||||||
| Product Form: | cps dur 100(10x10x250 mg) (blis.PVC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| Therapeutic Class: | 43 - CHOLERETICA, CHOLEKINETICA | ||||||||||
| ATC: |
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| Shelf life: | 48 | ||||||||||
| Container: | blister PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 04.11.2020 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| PIL: |
PIL_Ursogrix_250mg_tvrdé kapsuly_12_2021.pdf
|
| SPC: |
SPC_Ursogrix_250mg_tvrdé kapsuly_12_2021.pdf
|
| Safety feature | Yes |
| Data update: | 12.01.2022 |
