Details
Product Name in the RMS: Berinert 1500
MR Number: DE/H/0481/002
Date of outcome: 23.12.2014
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Known Active Substance Additional Strength/Form Full Dossier Biological: Blood Product Prescription Only |
Active Substances |
C1-esterase inhibitor human 1500 IU |
Form | Powder and solvent for solution for injection |
MA Holder in the RMS |
CSL Behring GmbH Emil-von-Behring-Str. 76 35041 Marburg, Germany |
RMS | Germany |
Date of last change | 02.12.2020 |
ATC-Code |
B06AC01 c1-inhibitor, plasma derived |
CMS Country | Domestic Product Name |
---|---|
Austria | |
Belgium | Berinert® 1500 eenheden poeder en oplosmiddel voor oplossing voor injectie of infusie |
Bulgaria | |
Cyprus | |
Czech Republic | |
Denmark | |
Finland | |
France | |
Greece | BERINERT |
Hungary | BERINERT 1500 NE por és oldószer oldatos injekcióhoz |
Iceland | |
Italy | |
Luxembourg | |
Malta | Berinert 1500IU Powder and solvent for solution for injection |
Norway | |
Poland | |
Portugal | |
Romania | Berinert 1500 1500 UI pulbere si solvent pentru soluţie injectabilă |
Slovak Republic | Berinert 1500 |
Slovenia | |
Spain | |
Sweden | 50666 |
United Kingdom |
Documents | |
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PAR: | DE_H_0481_002_PAR.pdf (11.08.2020) |
Finalised Product Information: | DE_H_0481_002_FinalPI_1of17.pdf (25.08.2017) |
Finalised Product Information: | DE_H_0481_002_FinalPI_2of17.pdf (25.08.2017) |
Finalised Product Information: | DE_H_0481_002_FinalPI_3of17.pdf (25.08.2017) |
Finalised Product Information: | DE_H_0481_002_FinalPI_4of17.pdf (25.08.2017) |
Finalised Product Information: | DE_H_0481_002_FinalPI_5of17.pdf (25.08.2017) |
Finalised Product Information: | DE_H_0481_002_FinalPI_6of17.pdf (25.08.2017) |
Finalised Product Information: | DE_H_0481_002_FinalPI_7of17.pdf (25.08.2017) |
Finalised Product Information: | DE_H_0481_002_FinalPI_8of17.pdf (25.08.2017) |
Finalised Product Information: | DE_H_0481_002_FinalPI_9of17.pdf (25.08.2017) |
Finalised Product Information: | DE_H_0481_002_FinalPI_10of17.pdf (25.08.2017) |
Finalised Product Information: | DE_H_0481_002_FinalPI_11of17.pdf (25.08.2017) |
Finalised Product Information: | DE_H_0481_002_FinalPI_12of17.pdf (25.08.2017) |
Finalised Product Information: | DE_H_0481_002_FinalPI_13of17.pdf (25.08.2017) |
Finalised Product Information: | DE_H_0481_002_FinalPI_14of17.pdf (25.08.2017) |
Finalised Product Information: | DE_H_0481_002_FinalPI_15of17.pdf (25.08.2017) |
Finalised Product Information: | DE_H_0481_002_FinalPI_16of17.pdf (25.08.2017) |
Finalised Product Information: | DE_H_0481_002_FinalPI_17of17.pdf (25.08.2017) |