Details

Product Name in the RMS: Pemetrexed-ratiopharm 100 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

MR Number: DE/H/5019/001
Date of outcome: 03.12.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	pemetrexed 105 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	13.01.2021
ATC-Code	L01BA04 Pemetrexed

CMS Country	Domestic Product Name
Austria
Belgium	Pemetrexed Teva 100 mg poeder voor concentraat voor oplossing voor intraveneuze infusie
Denmark
France
Hungary	PEMETREXED TEVA 100 mg por oldatos infúzióhoz való koncentrátumhoz
Italy
Luxembourg
Netherlands	Pemetrexed Teva 100 mg, poeder voor concentraat voor oplossing voor intraveneuze infusie
Slovenia
Spain
United Kingdom

Documents
PAR:	DE_H_5019_001_PAR.pdf (13.08.2019)
FinalSPC:	DE_H_5019_001_FinalSPC_1of3.pdf (04.12.2015)
FinalSPC:	DE_H_5019_001_FinalSPC_2of3.pdf (04.12.2015)
FinalSPC:	DE_H_5019_001_FinalSPC_3of3.pdf (04.12.2015)
FinalPL:	DE_H_5019_001_FinalPL.pdf (04.12.2015)
FinalLabelling:	DE_H_5019_001_FinalLabelling_1of6.pdf (04.12.2015)
FinalLabelling:	DE_H_5019_001_FinalLabelling_2of6.pdf (04.12.2015)
FinalLabelling:	DE_H_5019_001_FinalLabelling_3of6.pdf (04.12.2015)
FinalLabelling:	DE_H_5019_001_FinalLabelling_4of6.pdf (04.12.2015)
FinalLabelling:	DE_H_5019_001_FinalLabelling_5of6.pdf (04.12.2015)
FinalLabelling:	DE_H_5019_001_FinalLabelling_6of6.pdf (04.12.2015)
Finalised Product Information:	DE_H_5019_001_FinalPI_1of4.pdf (04.04.2019)
Finalised Product Information:	DE_H_5019_001_FinalPI_2of4.pdf (04.04.2019)
Finalised Product Information:	DE_H_5019_001_FinalPI_3of4.pdf (04.04.2019)
Finalised Product Information:	DE_H_5019_001_FinalPI_4of4.pdf (04.04.2019)