Details

Product Name in the RMS: Cyclolux 0,5 mmol/ml Injektionslösung

MR Number: DE/H/4015/001
Date of outcome: 03.06.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	gadoteric acid 279,32 mg/ml
Form	Solution for injection
MA Holder in the RMS	Sanochemia Pharmazeutika GmbH Landegger Straße 7 A-2491 Neufeld an der Leitha Austria
RMS	Germany
Date of last change	15.10.2021
ATC-Code	V08CA02 Gadoteric acid

CMS Country	Domestic Product Name
Austria	Cyclolux 0,5 mmol/ml Injektionslösung im Einzeldosisbehältnis
Czech Republic	CYCLOLUX 279 MG/ML INJEKČNÍ ROZTOK
Greece	CYCLOLUX
Hungary	CYCLOLUX 0,5 mmol/ml oldatos injekció, egyadagos
Poland	Cyclolux
Slovak Republic	Cyclolux 0,5 mmol/ml injekčný roztok
Spain
XI

Documents
PAR:	DE_H_4015_001_PAR.pdf (18.09.2019)
FinalSPC:	DE_H_4015_001_FinalSPC_1of4.zip (03.06.2015)
FinalSPC:	DE_H_4015_001_FinalSPC_2of4.zip (03.06.2015)
FinalSPC:	DE_H_4015_001_FinalSPC_3of4.zip (03.06.2015)
FinalSPC:	DE_H_4015_001_FinalSPC_4of4.zip (03.06.2015)
FinalPL:	DE_H_4015_001_FinalPL_1of2.pdf (25.09.2019)
FinalPL:	DE_H_4015_001_FinalPL_2of2.pdf (25.09.2019)
Finalised Product Information:	DE_H_4015_001_FinalPI_1of4.pdf (15.10.2021)
Finalised Product Information:	DE_H_4015_001_FinalPI_2of4.pdf (15.10.2021)
Finalised Product Information:	DE_H_4015_001_FinalPI_3of4.pdf (15.10.2021)
Finalised Product Information:	DE_H_4015_001_FinalPI_4of4.pdf (15.10.2021)