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) |