Details

Product Name in the RMS: Bortezomib Pliva 3,5 prašak za otopinu za injekciju

MR Number: HR/H/0102/002
Date of outcome: 29.06.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Initial Application Generic Chemical Substance Prescription Only
Active Substances	BORTEZOMIB 3,5 mg
Form	Powder for solution for injection
MA Holder in the RMS	Pliva Hrvatska d.o.o. Prilaz baruna Filipovića 25 10000 Zagreb
RMS	Croatia
Date of last change	24.06.2021
ATC-Code	L01XX32 Bortezomib

CMS Country	Domestic Product Name
Austria
Belgium
Cyprus
Denmark	Bortezomib Teva
Estonia	BORTEZOMIB TEVA
France
Germany	Bortezomib-ratiopharm 3,5 mg Pulver zur Herstellung einer Injektionslösung
Greece
Hungary
Ireland
Italy
Luxembourg
Norway
Portugal
Slovenia
Spain
Sweden
XI

Documents
PAR:	HR_H_0102_002_PAR.pdf (08.09.2015)
PARSummary:	HR_H_0102_002_PARSummary.pdf (08.09.2015)
FinalSPC:	HR_H_0102_002_FinalSPC.pdf (25.04.2019)
FinalPL:	HR_H_0102_002_FinalPL.pdf (25.04.2019)
Finalised Product Information:	HR_H_0102_002_FinalPI.pdf (29.06.2015)