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)