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 |
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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 |
Documents | |
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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) |