Details

Product Name in the RMS: Mitomycin 20 mg, Powder for Solution for Injection

MR Number: NL/H/3104/003
Date of outcome: 15.12.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Additional Strength/Form Generic Chemical Substance Prescription Only
Active Substances	mitomycin 20 mg
Form	Powder for solution for injection
MA Holder in the RMS	Accord Healthcare Limited
RMS	Netherlands
Date of last change	26.01.2019
ATC-Code	L01DC03 Mitomycin

CMS Country	Domestic Product Name
Austria
Belgium	Mitomycin Accord 20 mg Poeder voor oplossing voor injectie / infusie of intravesicaal gebruik
Bulgaria	Mitimycin Accord
Cyprus	MITOMYCIN PWD FOR SOL FOR INJ
Czech Republic	MITOMYCIN ACCORD 20 MG PRÁŠEK PRO INJEKČNÍ/INFUZNÍ NEBO INTRAVEZIKÁLNÍ ROZTOK
Finland
France
Germany	Mitomycin Accord 20 mg Pulver zur Herstellung einer Injektionslösung
Italy
Poland	Mitomycin Accord
Portugal
Slovak Republic	Mitomycín Accord 20 mg
Slovenia
Spain
United Kingdom

Documents
PAR:	NL_H_3104_003_PAR.pdf (24.11.2016)
PARSummary:	NL_H_3104_003_PARSummary.pdf (24.11.2016)
FinalSPC:	NL_H_3104_003_FinalSPC.pdf (22.12.2015)
FinalPL:	NL_H_3104_003_FinalPL.pdf (22.12.2015)
FinalLabelling:	NL_H_3104_003_FinalLabelling.pdf (22.12.2015)
Finalised Product Information:	NL_H_3104_003_FinalPI_1of2.pdf (02.02.2017)
Finalised Product Information:	NL_H_3104_003_FinalPI_2of2.pdf (02.02.2017)