Latest hum. ProductsDetails
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 | |
|---|---|
| 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) |
