Details

Product Name in the RMS: Bortezomib Zentiva 3,5 mg powder for solution for injection

MR Number: NL/H/3382/002
Date of outcome: 27.05.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Additional Strength/Form Generic Chemical Substance Prescription Only
Active Substances	BORTEZOMIB 3,5 mg
Form	Powder for solution for injection
MA Holder in the RMS	Zentiva, k.s. U kabelovny 130, Prague 10 10237 Czech Republic
RMS	Netherlands
Date of last change	26.04.2021
ATC-Code	L01XX32 Bortezomib

CMS Country	Domestic Product Name
France
Germany	Bortezomib Zentiva 3,5 mg Pulver zur Herstellung einer Injektionslösung
Italy
Poland	Bortezomib Zentiva
Portugal
Romania	Bortezomib Zentiva 3,5 mg pulbere pentru soluţie injectabilă
XI

Documents
PAR:	NL_H_3382_002_PAR.pdf (23.03.2016)
PARSummary:	NL_H_3382_002_PARSummary.pdf (23.03.2016)
FinalSPC:	NL_H_3382_002_FinalSPC.pdf (26.04.2021)
FinalPL:	NL_H_3382_002_FinalPL.pdf (26.04.2021)
Finalised Product Information:	NL_H_3382_002_FinalPI.pdf (23.04.2019)