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 |
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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) |