Details

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	11.11.2021
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	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
XI

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)