Details
Product Name in the RMS: Pemetrexed-ratiopharm 1000 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
MR Number: DE/H/5019/003
Date of outcome: 03.12.2015
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Abridged Initial Application Other Chemical Substance Prescription Only |
Active Substances |
pemetrexed 1000 mg |
Form | POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION |
MA Holder in the RMS |
ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany |
RMS | Germany |
Date of last change | 20.08.2020 |
ATC-Code |
L01BA04 Pemetrexed |
CMS Country | Domestic Product Name |
---|---|
Austria | |
Belgium | Pemetrexed Teva 1000 mg poeder voor concentraat voor oplossing voor intraveneuze infusie |
Croatia | Pemetreksed Pliva 1000 mg prašak za koncentrat za otopinu za infuziju |
France | |
Hungary | PEMETREXED TEVA 1000 mg por oldatos infúzióhoz való koncentrátumhoz |
Latvia | Pemetrexed Teva 1000 mg pulveris infūziju šķīduma koncentrāta pagatavošanai |
Luxembourg | |
Romania | PEMETREXED TEVA 1000 mg pulbere pentru concentrat pentru soluţie injectabilă |
Slovenia | |
United Kingdom |
Documents | |
---|---|
PAR: | DE_H_5019_003_PAR.pdf (13.08.2019) |
FinalSPC: | DE_H_5019_003_FinalSPC_1of3.pdf (04.12.2015) |
FinalSPC: | DE_H_5019_003_FinalSPC_2of3.pdf (04.12.2015) |
FinalSPC: | DE_H_5019_003_FinalSPC_3of3.pdf (04.12.2015) |
FinalPL: | DE_H_5019_003_FinalPL.pdf (04.12.2015) |
FinalLabelling: | DE_H_5019_003_FinalLabelling_1of6.pdf (04.12.2015) |
FinalLabelling: | DE_H_5019_003_FinalLabelling_2of6.pdf (04.12.2015) |
FinalLabelling: | DE_H_5019_003_FinalLabelling_3of6.pdf (04.12.2015) |
FinalLabelling: | DE_H_5019_003_FinalLabelling_4of6.pdf (04.12.2015) |
FinalLabelling: | DE_H_5019_003_FinalLabelling_5of6.pdf (04.12.2015) |
FinalLabelling: | DE_H_5019_003_FinalLabelling_6of6.pdf (04.12.2015) |
Finalised Product Information: | DE_H_5019_003_FinalPI_1of4.pdf (04.04.2019) |
Finalised Product Information: | DE_H_5019_003_FinalPI_2of4.pdf (04.04.2019) |
Finalised Product Information: | DE_H_5019_003_FinalPI_3of4.pdf (04.04.2019) |
Finalised Product Information: | DE_H_5019_003_FinalPI_4of4.pdf (04.04.2019) |