Details
Product Name in the RMS: Biphozyl 22 mmol/l
MR Number: NL/H/3002/001
Date of outcome: 20.10.2014
Type of application | |
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Level 1: Level 2: Level 3: Level 4: Level 5: |
Known Active Substance Initial Application Bibliographic Chemical Substance Prescription Only |
Active Substances |
magnesium chloride hexahydrate 3,05 g/l potassium chloride 0,31 g/l sodium carbonate 2,12 g/l sodium chloride 7,01 g/l SODIUM PHOSPHATE DIBASIC dihydrate 0,19 g/l |
Form | SOLUTION FOR HAEMODIALYSIS/HAEMOFILTRATION |
MA Holder in the RMS |
Baxter Holding B.V., Kobaltweg 49, 3542CE Utrecht, The Netherlands |
RMS | Netherlands |
Date of last change | 20.08.2020 |
ATC-Code |
B05ZB Hemofiltrates |
CMS Country | Domestic Product Name |
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Austria | Biphozyl Hämodialyse-/Hämofiltrationslösung |
Belgium | Biphozyl solution pour hémodialyse/hémofiltration |
Bulgaria | Biphozyl |
Croatia | Biphozyl otopina za hemodijalizu/ hemofiltraciju |
Cyprus | CALFODIL SOL FOR HAEMODIALYSIS / HAEMOFILTRATION |
Czech Republic | BIPHOZYL ROZTOK PRO HEMODIALÝZU/HEMOFILTRACI |
Denmark | |
Estonia | BIPHOZYL |
Finland | |
France | |
Germany | Calfodil 22 mmol/1 Hämofiltrations- und Hämodialyselösung |
Greece | CALFODIL |
Hungary | BIPHOZYL hemodializáló vagy hemofiltrációs oldat |
Iceland | Biphozyl 22 mmól/l Blóðskilunar-/blóðsíunarlausn |
Ireland | |
Italy | |
Latvia | Biphozyl šķīdums hemodialīzei/hemofiltrācijai |
Lithuania | Biphozyl hemodializės ar hemofiltracijos tirpalas |
Luxembourg | |
Malta | Calfodil 22 mmol/l solution for haemofiltration and haemodialysis |
Norway | Biphozyl |
Poland | Biphozyl |
Portugal | |
Romania | Biphozyl soluţie pentru hemodializă/hemofiltrare |
Slovak Republic | Biphozyl |
Slovenia | |
Spain | |
Sweden | |
United Kingdom |
Documents | |
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PAR: | NL_H_3002_001_PAR.pdf (13.05.2015) |
PARSummary: | NL_H_3002_001_PARSummary.pdf (13.05.2015) |
FinalSPC: | NL_H_3002_001_FinalSPC.pdf (28.04.2019) |
FinalPL: | NL_H_3002_001_FinalPL.pdf (28.04.2019) |
FinalLabelling: | NL_H_3002_001_FinalLabelling.pdf (28.04.2019) |
Finalised Product Information: | NL_H_3002_001_FinalPI_1of2.pdf (22.09.2017) |
Finalised Product Information: | NL_H_3002_001_FinalPI_2of2.pdf (22.09.2017) |