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 | 14.01.2021 |
ATC-Code |
L01XX32 Bortezomib |
CMS Country | Domestic Product Name |
---|---|
Austria | |
Belgium | |
Cyprus | |
Czech Republic | BORTEZOMIB TEVA 3,5 MG PRÁŠEK PRO INJEKČNÍ ROZTOK |
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 | |
United Kingdom |
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) |