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	24.04.2018
ATC-Code	L01XX32 Bortezomib

CMS Country	Domestic Product Name
Bulgaria	Bortezomib Actavis
Croatia
Czech Republic	Bortezomib Actavis 3,5 mg
Estonia
Hungary
Iceland	Bortezomib Actavis 3,5 mg Stungulyfsstofn, lausn
Latvia
Lithuania	Bortezomib Actavis 3,5 mg milteliai injekciniam tirpalui
Malta	Vortezomib Actavis
Poland
Romania
Slovak Republic
Slovenia

Documents
PAR:	DK_H_2395_001_PAR.pdf (09.06.2015)
PARSummary:	DK_H_2395_001_PARSummary.pdf (09.06.2015)
Finalised Product Information:	DK_H_2395_001_FinalPI.pdf (11.08.2016)