Details

Product Name in the RMS: Zegomib

MR Number: NL/H/3176/001
Date of outcome: 27.05.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	BORTEZOMIB 1 mg
Form	Powder for solution for injection
MA Holder in the RMS	Egis Pharmaceuticals Plc, Budapest, H-1106, Kereszturi ut 30-38 Hungary
RMS	Netherlands
Date of last change	10.05.2021
ATC-Code	L01XX32 Bortezomib

CMS Country	Domestic Product Name
Bulgaria	Bortegis
Hungary	ZEGOMIB 1 mg por oldatos injekcióhoz
Lithuania	Binila 1 mg milteliai injekciniam tirpalui
Romania	ZEGOMIB 1 mg pulbere pentru soluție injectabilă
Slovak Republic	Zegomib 1 mg

Documents
PAR:	NL_H_3176_001_PAR.pdf (24.03.2016)
PARSummary:	NL_H_3176_001_PARSummary.pdf (24.03.2016)
FinalPL:	NL_H_3176_001_FinalPL_1of2.pdf (04.06.2019)
FinalPL:	NL_H_3176_001_FinalPL_2of2.pdf (04.06.2019)
Finalised Product Information:	NL_H_3176_001_FinalPI_1of3.pdf (13.12.2016)
Finalised Product Information:	NL_H_3176_001_FinalPI_2of3.pdf (13.12.2016)
Finalised Product Information:	NL_H_3176_001_FinalPI_3of3.pdf (13.12.2016)