Details
Product Name in the RMS: Octaplex 1000
MR Number: DE/H/0464/002
Date of outcome: 16.07.2015
Type of application | |
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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 | 30.12.2020 |
ATC-Code |
B02BD01 Coagulation factor IX, II, VII and X in combination |
CMS Country | Domestic Product Name |
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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 | OCTAPLEX 1000 NE por és oldószer oldatos infúzióhoz |
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 | Octaplex |
Portugal | |
Romania | PRONATIV 1000 UI, pulbere şi solvent pentru soluţie perfuzabilă |
Slovak Republic | |
Slovenia | |
Spain | |
Sweden | |
United Kingdom |
Documents | |
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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) |