Latest hum. ProductsDetails
Product Name in the RMS: Octaplex 1000
MR Number: DE/H/0464/002
Date of outcome: 16.07.2015
| 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 |
blood coagulation factor IX human 1000 IU |
| Form | Powder and solvent for solution for injection |
| MA Holder in the RMS |
Octapharma GmbH Elisabeth-Selbert-Str. 11 40764 Langenfeld Germany |
| RMS | Germany |
| Date of last change | 06.08.2018 |
| ATC-Code |
B02BD01 Coagulation factor IX, II, VII and X in combination |
| CMS Country | Domestic Product Name |
|---|---|
| Austria | Octaplex 1000 I.E. Pulver und Lösungsmittel zur Herstellung einer Infusionslösung |
| Belgium | Octaplex 1000 UI poudre et solvant pour solution pour perfusion |
| Bulgaria | |
| Cyprus | Octaplex 1000 IU powder and solvent for solution for infusion |
| Czech Republic | Ocplex 1000 IU |
| Denmark | |
| Estonia | OCTAPLEX |
| Finland | |
| France | |
| Hungary | |
| Iceland | Octaplex 1000 a.e. Innrennslisstofn og leysir, lausn |
| Ireland | |
| Italy | |
| Latvia | Octaplex 1000 SV pulveris un šķīdinātājs infūziju šķīduma pagatavošanai |
| Lithuania | OCTAPLEX 1000 TV milteliai ir tirpiklis infuziniam tirpalui |
| Luxembourg | |
| Netherlands | Octaplex 1000 IE, poeder en oplosmiddel voor oplossing voor infusie |
| Norway | |
| Poland | |
| Portugal | |
| Romania | PRONATIV |
| Slovak Republic | |
| Slovenia | |
| Spain | |
| Sweden | |
| United Kingdom |
| Documents | |
|---|---|
| Finalised Product Information: | DE_H_0464_002_FinalPI_1of2.pdf (28.08.2017) |
| Finalised Product Information: | DE_H_0464_002_FinalPI_2of2.pdf (28.08.2017) |
