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
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	GAMBRO Lundia AB Magistratsvägen 16 S-22010 Lund Sweden
RMS	Netherlands
Date of last change	11.10.2019
ATC-Code	B05ZB Hemofiltrates

CMS Country	Domestic Product Name
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
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
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)