Details

Product Name in the RMS: Ulcamed 120 mg Filmtabletten

MR Number: AT/H/0598/001
Date of outcome: 02.10.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Initial Application Bibliographic Chemical Substance Prescription Only
Active Substances	bismuth subcitrate 120 mg
Form	Film coated tablet
MA Holder in the RMS	Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
RMS	Austria
Date of last change	29.12.2020
ATC-Code	A02BX05 Bismuth subcitrate

CMS Country	Domestic Product Name
Bulgaria	Ulcamed
Croatia	Ulcamed 120 mg filmom obložene tablete
Czech Republic	Ulcamed
Estonia
Hungary	Ulcamed 120 mg filmtabletta
Lithuania	Ulcamed 120 mg plėvele dengtos tabletės
Poland	Ulcamed
Romania	Ulcamed 120 mg comprimate filmate
Slovak Republic	Ulcamed 120 mg filmom obalené tablety
Slovenia

Documents
PAR:	AT_H_0598_001_PAR.pdf (23.10.2020)
FinalSPC:	AT_H_0598_001_FinalSPC.pdf (27.10.2020)
FinalPL:	AT_H_0598_001_FinalPL.pdf (27.10.2020)
FinalLabelling:	AT_H_0598_001_FinalLabelling.pdf (27.10.2020)
Finalised Product Information:	AT_H_0598_001_FinalPI.pdf (05.09.2016)