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 2 mg
Form	Powder for solution for injection
MA Holder in the RMS	Accord Healthcare Limited
RMS	Netherlands
Date of last change	01.09.2020
ATC-Code	L01DC03 Mitomycin

CMS Country	Domestic Product Name
Austria	Mitomycin Accord 2 mg Pulver zur Herstellung einer Injektions- / Infusionslösung oder Lösung zur int
Belgium	Mitomycin Accord 2 mg Poeder voor oplossing voor injectie / infusie of intravesicaal gebruik
Bulgaria	Mitomycin Acoord
Cyprus	MITOMYCIN PWD FOR SOL FOR INJ
Czech Republic	MITOMYCIN ACCORD 2 MG PRÁŠEK PRO INJEKČNÍ/INFUZNÍ NEBO INTRAVEZIKÁLNÍ ROZTOK
Estonia
Finland
France
Germany	Mitomycin Accord 2 mg Pulver zur Herstellung einer Injektionslösung
Iceland
Italy
Malta	Mitomycin 2 mg Powder for solution for Injection/Infusion or Intravesical use
Poland	Mitomycin Accord
Portugal
Slovak Republic
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)