Details

Product Name in the RMS: Regiocit

MR Number: NL/H/2979/001
Date of outcome: 01.10.2014

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	sodium chloride 140 mmol/l sodium citrate 18 mmol/l
Form	Solution for haemofiltration
MA Holder in the RMS	GAMBRO Lundia AB Magistratsvägen 16 S-22010 Lund Sweden
RMS	Netherlands
Date of last change	30.06.2021
ATC-Code	B05ZB Hemofiltrates

CMS Country	Domestic Product Name
Austria
Belgium
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
Norway
Poland
Portugal
Romania
Slovak Republic
Slovenia
Spain
Sweden
XI

Documents
PAR:	NL_H_2979_001_PAR.pdf (17.02.2015)
PARSummary:	NL_H_2979_001_PARSummary.pdf (17.02.2015)
FinalSPC:	NL_H_2979_001_FinalSPC.pdf (25.03.2019)
FinalPL:	NL_H_2979_001_FinalPL.pdf (04.05.2021)
FinalLabelling:	NL_H_2979_001_FinalLabelling.pdf (27.03.2019)