| Code | 89458 | ||||||||||
| MA number | 43/0317/10-S | ||||||||||
| Product Form: | tbl flm 100x500 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | National | ||||||||||
| MAH, country: | Dr. Falk Pharma GmbH, Germany | ||||||||||
| 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 8(3) application - known active substance |
| MA issued: | 19.05.2010 |
| SPC: |
SPC_Ursofalk 500 mg tbl_Feb 2016.docx
|
| PIL: |
PIL_Ursofalk 500 mg tbl flm_Feb 2016.docx
|
| Safety feature | Yes |
| Data update: | 15.04.2019 |
