Latest hum. ProductsDetails
Product Name in the RMS: Prothromplex TOTAL 600 I.E.
MR Number: AT/H/0373/001
Date of outcome: 07.07.2010
| Type of application | |
|---|---|
|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Known Active Substance Initial Application Full Dossier Biological: Blood Product Prescription Only |
| Active Substances |
blood coagulation factors II, VII, IX, X in combination (Prothrombin complex) 600 IU/20 ml |
| Form | Powder and solvent for solution for injection |
| MA Holder in the RMS |
Baxter AG Industriestraße 67 A-1221 Vienna |
| RMS | Austria |
| Date of last change | 29.10.2020 |
| ATC-Code |
B02BD01 Coagulation factor IX, II, VII and X in combination |
| CMS Country | Domestic Product Name |
|---|---|
| Belgium | |
| Bulgaria | |
| Czech Republic | Prothromplex Total NF |
| Denmark | |
| Estonia | PROTHROMPLEX TOTAL |
| Germany | Prothromplex TOTAL 600 I.E. |
| Greece | PROTHROMPLEX TOTAL |
| Hungary | PROTHROMPLEX TOTAL 600 NE por és oldószer oldatos injekcióhoz |
| Ireland | |
| Italy | |
| Latvia | Prothromplex 600 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai |
| Lithuania | Prothromplex 600 TV milteliai ir tirpiklis injekciniam tirpalui |
| Luxembourg | |
| Malta | Prothromplex Total 600 IU powder and solvent for solution for injection |
| Netherlands | |
| Norway | |
| Poland | |
| Portugal | |
| Romania | Prothromplex TOTAL 600 UI pulbere şi solvent pentru soluţie injectabilă |
| Slovak Republic | |
| Slovenia | |
| Spain | |
| United Kingdom |
| Documents | |
|---|---|
| PAR: | AT_H_0373_001_PAR.pdf (25.03.2020) |
| FinalSPC: | AT_H_0373_001_FinalSPC.pdf (01.09.2015) |
| FinalPL: | AT_H_0373_001_FinalPL.pdf (14.02.2020) |
| FinalLabelling: | AT_H_0373_001_FinalLabelling.pdf (07.08.2017) |
| Finalised Product Information: | AT_H_0373_001_FinalPI.pdf (29.10.2020) |
