Details
Product Name in the RMS: Gemcitabine 40 mg/ml Concentrate for Solution for Infusion
MR Number: NL/H/2447/001
Date of outcome: 04.10.2012
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Abridged Initial Application Other Chemical Substance Prescription Only |
Active Substances |
gemcitabine hydrochloride 40 mg/ml |
Form | Concentrate for solution for infusion |
MA Holder in the RMS |
Fresenius Kabi Nederland BV Amersfoortseweg 10E 3712BC Huis ter Heide The Netherlands |
RMS | Netherlands |
Date of last change | 18.12.2020 |
ATC-Code |
L01BC05 Gemcitabine |
CMS Country | Domestic Product Name |
---|---|
Belgium | Gemcitabine Fresenius Kabi |
Denmark | |
Hungary | GEMCITABIN KABI 40 mg/ml koncentrátum oldatos infúzióhoz |
Iceland | |
Ireland | |
Norway | Gemkabi |
Portugal | |
Romania | Gemcitabina Kabi 40 mg/ml concentrat pentru soluţie perfuzabilă |
Slovak Republic | Gemcitabine Kabi 40 mg/ml infúzny koncentrát |
Spain | |
Sweden | |
United Kingdom |
Documents | |
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PAR: | NL_H_2447_001_PAR.pdf (17.09.2013) |
FinalSPC: | NL_H_2447_001_FinalSPC.pdf (14.09.2015) |
FinalPL: | NL_H_2447_001_FinalPL.pdf (14.09.2015) |