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	21.08.2020
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
United Kingdom