Details

Product Name in the RMS: Bortezomib Actavis

MR Number: DK/H/2395/001
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 3,5 mg
Form	Powder for solution for injection
MA Holder in the RMS	Actavis Group PTC ehf. Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland
RMS	Denmark
Date of last change	21.08.2020
ATC-Code	L01XX32 Bortezomib

CMS Country	Domestic Product Name
Bulgaria	Bortezomib Actavis
Croatia
Czech Republic	Bortezomib Actavis 3,5 mg
Estonia
Hungary	BORTEZOMIB ACTAVIS 3,5 mg por oldatos injekcióhoz
Iceland	Bortezomib Actavis 3,5 mg Stungulyfsstofn, lausn
Malta	Vortezomib Actavis
Romania	Bortezomib Actavis 3,5 mg pulbere pentru solutie injectabila
Slovenia

Documents
PAR:	DK_H_2395_001_PAR.pdf (09.06.2015)
PARSummary:	DK_H_2395_001_PARSummary.pdf (09.06.2015)
FinalSPC:	DK_H_2395_001_FinalSPC.pdf (15.05.2019)
FinalPL:	DK_H_2395_001_FinalPL.pdf (15.05.2019)
Finalised Product Information:	DK_H_2395_001_FinalPI.pdf (11.08.2016)