Details

Product Name in the RMS: Sulfesa 10 mg filmsko obložene tablete

MR Number: SI/H/0137/002
Date of outcome: 29.04.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	solifenacin succinate 10 mg
Form	Film coated tablet
MA Holder in the RMS	Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austria
RMS	Slovenia
Date of last change	09.09.2021
ATC-Code	G04BD08 Solifenacin

CMS Country	Domestic Product Name
Austria	Solifenacin Sandoz 10 mg Filmtabletten
Cyprus	SOLIFACIN SANDOZ 10mg TABS
Czech Republic	MUSCARISAN 10 MG
Denmark	Solifenacin "Sandoz"
Finland
Greece
Norway	Solifenacin Sandoz
Poland	Solifenacin Sandoz
Slovak Republic	Solifenacin Sandoz 10 mg
Spain

Documents
FinalSPC:	SI_H_0137_002_FinalSPC.pdf (29.08.2019)
FinalPL:	SI_H_0137_002_FinalPL.pdf (22.02.2019)
Finalised Product Information:	SI_H_0137_002_FinalPI_1of3.pdf (21.10.2020)
Finalised Product Information:	SI_H_0137_002_FinalPI_2of3.pdf (21.10.2020)
Finalised Product Information:	SI_H_0137_002_FinalPI_3of3.pdf (21.10.2020)