Code | 53549 | ||||||||||
MA number | 43/0543/08-S | ||||||||||
Product Form: | sus por 2x250 ml (fľ.skl.hnedá) | ||||||||||
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: |
|
||||||||||
Shelf life: | 48 | ||||||||||
Container: | brown glass bottle | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 15.10.2008 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric contraindication: | Yes |
PIL: | PIL_Ursofalk 250 mg_5ml suspenzia_november2020.docx |
SPC: | SPC_Ursofalk 250 mg_5ml suspenzia_november2020.docx |
Safety feature | Yes |
Data update: | 15.04.2019 |